[Federal Register Volume 64, Number 93 (Friday, May 14, 1999)]
[Proposed Rules]
[Pages 26330-26344]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12040]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 207, 607, and 807
[Docket No. 98N-1215]
Foreign Establishment Registration and Listing
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its regulations pertaining to the registration of foreign
establishments and the listing of human drugs, animal drugs, biological
products, and devices. The proposal would require foreign
establishments whose products are imported or offered for import into
the United States to register with FDA. The proposal would also require
foreign establishments to identify a United States agent and would
describe some of the agent's responsibilities. The agency is proposing
these changes to implement section 417 of the Food and Drug
Administration Modernization Act of 1997 (FDAMA) as it pertains to
foreign establishment registration.
DATES: Written comments by July 28, 1999. Written comments on the
information collection requirements by June 14, 1999.
ADDRESSES: Submit written comments to the Dockets Management Branch
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit written comments on the information
collection requirements to the Office of Information and Regulatory
Affairs, Office of Management and Budget (OMB), New Executive Office
Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20502, Attn: Wendy
Taylor, Desk Officer for FDA.
FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy (HF-
23), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD
20857, 301-827-3380.
SUPPLEMENTARY INFORMATION:
I. Introduction
On November 21, 1997, the President signed FDAMA into law (Pub. L.
105-115). Section 417 of FDAMA amended section 510(i) of the Federal
Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360(i)) to require,
in part, that:
(1) Any establishment within any foreign country engaged in the
manufacture, preparation, propagation, compounding, or processing of
a drug or a device that is imported or offered for import into the
United States shall register with the Secretary the name and place
of business of the establishment and the name of the United States
agent for the establishment.
(2) The establishment shall also provide the information
required by subsection (j).
* * *
(Section 510(j) of the act pertains to product listing.)
Generally speaking, before FDAMA's enactment, foreign
establishments could, but were not required to, register with FDA.
Foreign establishments were required, however, to list their products
regardless of whether the foreign establishment was registered (see,
e.g.,
[[Page 26331]]
former section 510(i) of the act, Sec. 207.40(a) (21 CFR 207.40(a)) (38
FR 6258 at 6267, March 7, 1973)). This generated confusion and resulted
in foreign establishments not complying with the listing requirement.
Moreover, in some cases, the lack of registration information on
foreign establishments made it difficult to determine the source of
specific imported products, particularly products that were impure,
counterfeit products, or products whose safety or efficacy had not been
established.
In contrast, before FDAMA was enacted, the act required--and
continues to require--all domestic establishments to register unless
they are specifically exempted from the registration requirement and to
list their products.
FDAMA changed this situation by requiring all foreign
establishments engaged in the manufacture, preparation, propagation,
compounding, or processing of a drug or a device that is imported or
offered for import into the United States to register. It also
emphasized that foreign establishments must list their products. Thus,
under the act, as revised by FDAMA, both foreign and domestic
establishments must now register and list their products.
II. Description of the Proposed Rule
The proposed rule would amend the establishment registration and
listing regulations in part 207 (21 CFR part 207) (human and animal
drugs), part 607 (21 CFR part 607) (human blood and blood products),
and part 807 (21 CFR part 807) (devices). In general, the proposal
would remove the distinctions between domestic and foreign
establishments where appropriate, would require foreign establishments
to identify a United States agent, and would describe some of the
United States agent's duties.
The proposal would also make minor technical amendments, such as
updating addresses of FDA offices and the names of marketing
applications, to be consistent with current FDA practices.
The proposed rule would not affect veterinary biologics because
such products are regulated by the U.S. Department of Agriculture.
A. Proposed Changes to Part 207 (Human Drugs and Animal Drugs)
1. Section 207.3--Definitions
a. Definition of ``commercial distribution''. Section 207.3(a)(5)
currently defines ``commercial distribution'' as:
any distribution of a human drug except for investigational use
under part 312 of this chapter, and any distribution of an animal
drug or an animal feed bearing or containing an animal drug for
noninvestigational uses, but the term does not include internal or
interplant transfer of a bulk drug substance between registered
domestic establishments within the same parent, subsidiary, and/or
affiliate company.
The proposed rule would add a new sentence to this definition to
clarify that, for foreign establishments, commercial distribution does
not include distribution of a human or animal drug that is neither
imported nor offered for import into the United States. This change is
intended to reflect the statutory language limiting the registration
requirement to those foreign establishments that are ``engaged in the
manufacture, preparation, propagation, compounding, or processing of a
drug or a device that is imported or offered for import into the United
States'' (emphasis added), as well as the definition of ``interstate
commerce'' in section 201(b) of the act (21 U.S.C. 321(b)).
b. Definition of ``United States agent''. The proposed rule would
define ``United States agent,'' at new Sec. 207.3(a)(11), as ``a person
residing or maintaining a place of business in the United States whom a
foreign establishment designates as its agent.'' Black's Law Dictionary
defines ``reside'' as ``live, dwell, abide, sojourn, stay, remain,
lodge'' and ``to settle oneself or a thing in a place, to be stationed,
to remain or stay, to dwell permanently or continuously * * *'' (see
Black's Law Dictionary 1308 (6th ed. 1990)) and defines ``place of
business,'' in part, as ``The location at which one carries on his
business or employment'' (id. at 1149). Thus, by using the term
``residing'' and referring to a ``place of business,'' proposed
Sec. 207.3(a)(11) would permit a foreign establishment to designate, as
its United States agent, either an individual who lives in the United
States or a firm or company in the United States where an individual or
individuals conduct business or are employed. The definition of United
States agent would exclude mailboxes, answering machines or services,
or other places where an individual acting as the foreign
establishment's agent is not physically present.
Additionally, FDA emphasizes that it interprets section 510(i)(1)
of the act as allowing for only one United States agent for each
foreign establishment, for purposes of section 510(i) of the act. This
interpretation is both efficient (because FDA would communicate or
interact with only one United States agent rather than multiple agents
who represent or purport to represent the same foreign establishment)
and consistent with section 510(i)(1) of the act because the act refers
to the United States agent in singular, rather than plural, terms.
2. Section 207.7--Establishment Registration and Product Listing for
Human Blood and Blood Products and for Medical Devices
Section 207.7(a) currently states, in part, that owners and
operators of human blood and blood product establishments are to
register and list their products in accordance with part 607.
The proposal would revise the address for the office in the Center
for Biologics Evaluation and Research that receives the registration
and listing information.
3. Section 207.10--Exemptions for Domestic Establishments
Currently, Sec. 207.10 exempts various domestic entities or persons
from the registration requirements. Some exemptions reflect the
statutory language in section 510(g) of the act, whereas others were
exempted by FDA because registering such persons would not be necessary
to protect the public health.
The proposed rule would amend Sec. 207.10 to delete the word
``domestic'' from its title, so that the provision pertains to
exemptions for both foreign and domestic establishments. FDA is
proposing this change because the establishment registration
requirements now apply to both domestic and foreign establishments, so
no further distinction is necessary in the heading of Sec. 207.10.
However, the exemptions currently found in Sec. 207.10(a) and (b)
(pertaining to pharmacies operating under applicable local laws and to
hospitals, clinics, and public health agencies that maintain
establishments in conformance with local laws regulating the practice
of pharmacy or medicine) would remain limited to establishments in the
United States and its territories. FDA is not proposing to extend these
exemptions to foreign pharmacies, hospitals, clinics, and public health
agencies because the statutory exemption for pharmacies in section
510(g)(1) of the act does not extend to foreign pharmacies and because
FDA has limited experience with or access to foreign laws on the
practice of pharmacy or medicine and, therefore, cannot readily
determine whether these foreign establishments are in compliance with
such laws. The agency also lacks sufficient information to make a
finding, under section 510(g)(5) of the act, that registration by such
foreign establishments is not
[[Page 26332]]
necessary to protect the public health. However, it is unlikely that
many foreign pharmacies, hospitals, clinics, or public health agencies
export or offer to export drugs or devices to the United States, so few
of these foreign establishments should be subject to the registration
requirement. Those that do export to the United States should be in
FDA's inventory of registered foreign establishments for the efficient
administration and enforcement of the act.
4. Section 207.20--Who Must Register and Submit a Drug List
Section 207.20(a) currently requires ``owners and operators of all
drug establishments, not exempt under section 510(g) of the act or
subpart D of this part 207, that engage in the manufacture,
preparation, propagation, compounding, or processing of a drug or
drugs'' to register and list every drug in commercial distribution. The
rule also states that owners and operators must register and list every
drug in commercial distribution ``whether or not the output of such
establishment or any particular drug so listed enters interstate
commerce * * *.'' However, under the current rule, drug listing is not
required ``at this time for the manufacturing, preparation,
propagation, compounding, or processing of an animal feed (including a
Type B and Type C medicated feed) bearing or containing an animal drug
* * *.''
The proposed rule would amend Sec. 207.20(a) to clarify that the
exemptions are under section 510(g) of the act or subpart B
(``Exemptions'') of part 207. The agency is making this change because
the proposed rule would place all exemptions in subpart B of part 207
and would remove all exemptions from subpart D.
The proposal would also revise Sec. 207.20(a) so that the language
requiring owners and operators to register their establishments and to
list drugs, whether or not the output of the establishment or any
particular drug so listed enters interstate commerce, would apply only
to domestic firms. FDA is proposing this change because the agency has
no intent to require foreign establishments to list drugs that do not
enter interstate commerce by being imported or offered for import into
the United States.
The proposal would also make two minor amendments to
Sec. 207.20(a). The proposed rule would delete the phrase ``at this
time'' because the phrase is unnecessary. The proposal would also move
the parenthetical language referring to Type B and Type C medicated
feed so that it refers accurately to animal feeds bearing or containing
an animal drug rather than to animal feeds generally and revise the
parenthetical language so that it refers to Type B ``or'' Type C
medicated feed. This would eliminate any misconception that the product
be both a Type B and Type C medicated feed.
Additionally, FDA notes that Sec. 207.20(a), as currently written,
permits a company to submit listing information on behalf of a parent,
subsidiary, and/or affiliate company for all establishments when
operations are conducted at more than one establishment and there
exists joint ownership and control among all the establishments. FDA
interprets this provision, and similar provisions at Secs. 607.20(a)
and 807.20(a), as including foreign establishments so long as
operations are conducted at more than one establishment and there
exists joint ownership and control among all the establishments.
The proposed rule would also add ``abbreviated new drug
applications'' and ``abbreviated new animal drug applications'' to the
list of marketing applications in Sec. 207.20(c). FDA is proposing
these actions because such applications, which were created by the Drug
Price Competition and Patent Term Restoration Act and the Generic
Animal Drug and Patent Term Restoration Act, are marketing applications
that require a registered establishment. These applications were
inadvertently omitted from previous rulemakings amending part 207. (The
agency notes that, in the Federal Register of July 31, 1998 (63 FR
40858), it published a proposed rule that would eliminate establishment
and product licenses and implement biologics licenses.)
5. Section 207.21--Times for Registration and Drug Listing
Section 207.21 currently describes when establishments should
register and submit listing information and states that an owner or
operator of an establishment that has just begun manufacturing or
processing drugs should register within 5 days after submitting a new
drug application, new animal drug application, medicated feed
application, antibiotic application, or an establishment license
application to manufacture a biological product. (The agency notes
that, in the Federal Register of July 31, 1998 (63 FR 40858), it
published a proposed rule that would eliminate establishment and
product licenses and implement biologics licenses.)
The proposed rule would add ``abbreviated new drug applications''
and ``abbreviated new animal drug applications'' to the list of
marketing applications in Sec. 207.21. As stated earlier, these
applications were inadvertently omitted from previous rulemakings
amending part 207.
6. Section 207.25--Information Required in Registration and Drug
Listing
Section 207.25(b)(2) currently requires the numbers for various
marketing applications to be included in the drug listing information
submitted to the agency. For example, if a new drug application were
assigned number 20-570, the application number that would be included
in the drug listing information would be NDA 20-570.
The proposed rule would add abbreviated new animal drug
applications to the list of marketing applications in Sec. 207.25. As
stated earlier, this action is necessary because abbreviated new animal
drug applications were inadvertently omitted from previous rulemakings
amending part 207.
7. Section 207.37--Inspection of Registrations and Drug Listings
Section 207.37(a) currently states where copies of registration
forms filed by establishments are available for inspection. In general,
the forms are available at the Center for Drug Evaluation and Research
and at FDA district offices.
The proposed rule would amend Sec. 207.37(a) to update the
addresses in the Center for Drug Evaluation and Research and would
state that copies of registration forms submitted by foreign
establishments are available for inspection at the Office of Compliance
in the Center for Drug Evaluation and Research. Copies of forms
submitted by domestic establishments would continue to be available for
inspection at FDA district offices and at the Office of Compliance in
the Center for Drug Evaluation and Research.
The proposal would also update the addresses in Sec. 207.37(b).
8. Section 207.40--Drug Listing Requirements for Foreign Drug
Establishments
Section 207.40 currently requires foreign drug establishments to
comply with drug listing requirements and prohibits the importation of
drugs that are not listed (except for investigational drugs). It also
requires foreign establishments to submit drug listing information in
English and to provide the name and address of the
[[Page 26333]]
establishment and the person responsible for submitting the drug
listing information.
Proposed Sec. 207.40(a) would revise the existing language to
require foreign establishments whose drugs are imported or offered for
import into the United States to comply with the establishment
registration and listing requirements in subpart C (``Procedures for
domestic drug establishments''), unless exempt under subpart B
(``Exemptions''). The proposal would expressly require foreign
establishments to register as required by section 510(i)(1) of the act.
Proposed Sec. 207.40(b) would prohibit the importation of drugs
from unregistered foreign establishments, in addition to prohibiting
the importation of unlisted drugs. This action is consistent with
several provisions of the act. Section 301(p) of the act (21 U.S.C.
331(p)) considers a foreign establishment's failure to register or to
submit listing information to be a prohibited act. Section 501(a)(2)(B)
of the act (21 U.S.C. 351(a)(2)(B)) considers a drug to be adulterated
if the methods used in or the facilities or controls used for the
drug's manufacture, processing, packing, or holding do not conform to
current good manufacturing practice (CGMP). Additionally, under section
801(a) of the act (21 U.S.C. 381(a)), FDA may refuse to admit into the
United States drugs that appear to be: (1) Manufactured, processed, or
packed under insanitary conditions; (2) forbidden or restricted in sale
in the country in which they are produced or from which they are
exported; or (3) adulterated, misbranded, or in violation of section
505 of the act (21 U.S.C. 355). Here, if a foreign establishment fails
to register (thereby engaging in a prohibited act), it is likely that
FDA has not inspected the establishment. As a result, FDA would be
unable to determine whether that foreign establishment meets CGMP.
Consequently, drugs from such unregistered establishments would appear
to be adulterated under section 801(a)(3) of the act. Therefore, to
enforce sections 301(p), 501(a), and 801(a) of the act effectively, in
conjunction with section 510(i) of the act as it pertains to foreign
establishment registration, the agency is proposing to amend
Sec. 207.40(b) to prohibit the importation of drugs that are not
manufactured, prepared, propagated, compounded, or processed at a
registered foreign establishment.
Moreover, this interpretation is consistent with the purpose of the
registration provision as originally enacted in 1962. While the FDAMA
legislative history is virtually silent on the purpose of foreign
registration, the Drug Amendments of 1962 make clear the connection
between registration and factory inspection. The Drug Amendments
amended the act to include, among other things, a registration
provision requiring domestic drug establishments to register and
authorizing foreign establishments to register, and a ``current good
manufacturing practice'' provision which now appears at section
501(a)(2)(B) of the act. According to the Senate Report accompanying
the amendments, the purpose of the registration provision is
to assist the [FDA] to identify and inspect all places where
drugs are being made, and to take appropriate action * * * against
those who fail to register * * * The committee believes that drugs
should not be on the market unless the [FDA] knows who is making
them, and where they are being made, and is able to inspect the
facilities in which they are being made. This will help to stop
illicit and substandard manufacturers who do not follow the methods
or establish the controls called for by good manufacturing practice.
The registration system * * * is thus a facet of * * * the
provisions on quality manufacturing controls * * *.''
S. Rept. 87-1744 (1962), reprinted in 1962 U.S.C.C.A.N., 2884, 2888-89.
Therefore, the agency believes that the act supports a prohibition on
importation of drugs manufactured by unregistered establishments.
FDA acknowledges that section 502(o) of the act (21 U.S.C. 352(o))
considers a drug to be misbranded if the drug was manufactured,
prepared, propagated, compounded, or processed in an establishment that
is not registered in any State and that FDAMA did not amend section
502(o) of the act to include language describing a similar restriction
on drugs from unregistered foreign establishments. Nevertheless, as
explained above, FDA has sufficient legal authority to prohibit the
importation of drugs from unregistered foreign establishments, as a
regulation for the efficient enforcement of the act under section
701(a) of the act (21 U.S.C. 371(a)), and such a prohibition would give
foreign establishments, like their domestic counterparts, an incentive
to register.
Proposed Sec. 207.40(b) would also require foreign establishments
to submit registration and listing information, including labels and
labeling, in English. This would be consistent with the existing
provision which requires that listing information be submitted in the
English language.
Section 207.40(c) currently requires every foreign drug
establishment to submit, as part of its drug listing, the
establishment's name and address and the name of the individual
responsible for submitting the listing information. It also directs the
foreign establishment to report any changes at specified intervals.
The proposed rule would revise Sec. 207.40(c) to require each
foreign establishment to submit the name, address, and phone number of
its United States agent as part of the establishment's initial and
updated registration information. As stated earlier, FDA interprets
section 510(i) of the act as allowing for only one United States agent
for each foreign establishment and providing a foreign establishment
the discretion to choose either an individual person or entity to serve
as its United States agent. Some establishments may prefer to select a
company or firm as the United States agent rather than depend on a
single person, and so proposed Sec. 207.40(c) would allow an entity to
be the United States agent.
Proposed Sec. 207.40(c) would also require a foreign establishment
to report changes in the United States agent's name, address, or phone
number to FDA within 5 days of the change and would require each
foreign establishment to designate only one United States agent. In
drafting this provision, FDA considered allowing such changes to be
reported either by the foreign establishment or by the United States
agent because, on rare occasions, the agency has contacted individuals
whom establishments had identified as their agent or representative
only to find that the individual had terminated its relationship with
the establishment or was unaware that the establishment had designated
the individual as its representative. Although the proposal would
permit only establishments to report changes in the United States
agent's name, address, or phone number, the agency invites comments as
to whether the rule should permit the United States agent to report
such changes as well.
Additionally, proposed Sec. 207.40(c) would require the United
States agent to reside or maintain a place of business in the United
States, and, upon request from FDA, to assist FDA in communications
with the foreign drug establishment, to respond to questions about the
establishment's products that are imported or offered for import into
the United States, and to assist FDA in scheduling inspections of the
foreign drug establishment. For example, in the event of a product
recall, the agency might ask the United States agent about the
product's distribution in the United
[[Page 26334]]
States in order to facilitate the recall (although, in many instances,
FDA will either have information on the imported product's distribution
or be able to acquire such information from other government agencies
so as to reduce the need to contact the United States agent on such
matters). The agency is proposing these requirements because its
experience indicates that communications with foreign establishments
are much better and problems or concerns are resolved much faster when
the agency can work with a person residing or maintaining a place of
business in the United States.
FDA considered, but did not propose, a requirement that the United
States agent possess sufficient knowledge of English to facilitate
communications between FDA and the foreign establishment. The agency
chose to omit such a requirement, in part, because the United States
agent, by virtue of residing or maintaining a place of business in the
United States, should be able to communicate in English or may be
assumed to have sufficient knowledge of English. Should this assumption
prove to be incorrect, FDA may revise the rule to require the United
States agent to be able to communicate in English.
The proposal would also consider information or documents provided
by FDA to the United States agent to be equivalent to providing the
same information or documents to the foreign drug establishment. This
provision would apply when the agency is unable to contact the foreign
manufacturer directly or expeditiously, including (but not limited to)
situations where FDA has been unsuccessful in contacting the foreign
establishment directly because the establishment has moved, when FDA
correspondence sent directly to the foreign establishment has been
returned to the agency because the local postal authorities cannot
locate the foreign establishment, or in emergencies. This proposed
provision, however, suggests that foreign establishments should select
their United States agent carefully. FDA is aware that some foreign
establishments have multiple distributors in the United States, but
sometimes select one distributor as the establishment's representative
or agent. This may present a problem if FDA, under proposed
Sec. 207.40(c), sought to provide certain documents or information to a
distributor-agent concerning products that might have been supplied to
or actions taken by a different distributor. For example, foreign
establishment ``A'' might have three distributors in the United States
(distributors ``B,'' ``C,'' and ``D'') and have selected distributor B
as its United States agent. If FDA, under proposed Sec. 207.40(c), were
to contact distributor B, in its capacity as the United States agent,
about problems associated with a particular import, such contact might
inadvertently present business concerns for the foreign establishment
because distributor B might be unaware of other distributors in the
United States or other products shipped to the United States, or FDA
might be unaware that the information concerned a product that had not
been shipped to distributor B. Distributor B also might not relay the
information from FDA to the foreign establishment if the failure to
relay the information would confer a competitive advantage to itself.
Contact between FDA and a United States agent might also present
issues involving trade secrets or confidential commercial information.
For example, section 301(j) of the act, with few exceptions, prohibits
the agency from disclosing trade secrets. Yet there may be instances
where the agency needs to discuss information which may involve trade
secrets or confidential commercial information. If the agency is unable
to contact the foreign manufacturer, it may not be permitted to discuss
the information with the United States agent, even if a public health
emergency exists.
Thus, FDA advises foreign establishments to choose their United
States agents carefully in order to avoid any conflict of interest or
confidentiality problems.
B. Proposed Changes to Part 607 (Human Blood and Blood Products)
1. Section 607.3--Definitions
a. Definition of ``commercial distribution''. Section 607.3(e)
currently defines ``commercial distribution,'' in part, as ``any
distribution of a blood product except pursuant to the investigational
use provisions of part 312 of this chapter * * *.''
The proposal would add a new sentence to Sec. 607.3(e) to state
that, for foreign establishments, commercial distribution does not
include distribution of any blood or blood product that is neither
imported nor offered for import into the United States. This change is
necessary because FDA does not intend to require foreign establishments
to register or to list blood products that are not imported to or
offered for import into the United States, consistent with the language
of section 510(i)(1) of the act.
b. Definition of ``United States agent''. The proposed rule would
define ``United States agent,'' in a new Sec. 607.3(j), as ``any person
residing or maintaining a place of business in the United States whom a
foreign establishment designates as its agent.'' This definition, and
FDA's interpretation of the definition, would be identical to those in
proposed Sec. 207.3(a)(11).
2. Section 607.7--Establishment Registration and Product Listing of
Blood Banks and Other Firms Manufacturing Human Blood and Blood
Products
Section 607.7(b) and (c) currently provide an address for the
Center for Biologics Evaluation and Research from which registration
forms may be obtained and to which they may be sent.
The proposed rule would amend Sec. 607.7(b) and (c) to update the
address.
3. Section 607.20--Who Must Register and Submit a Blood Product List
Section 607.20(a) currently states, in part, that an owner or
operator of an establishment that engages in the manufacture of blood
products must register and submit a list of every blood product in
commercial distribution, ``whether or not the output of such blood
product establishment or any particular blood product so listed enters
interstate commerce.''
The proposal would revise Sec. 607.20(a) so that the language
requiring owners and operators to register their establishments and to
list blood products whether or not the output of the establishment or
any particular blood product so listed enters interstate commerce
applies only to domestic firms. This change is consistent with proposed
Sec. 607.3(e).
4. Section 607.22--How and Where to Register Establishments and List
Blood Products
Section 607.22 currently describes which forms should be used for
registration and listing purposes and provides an address from which
the forms may be obtained. Section 607.22(b) further states that
listing information may be submitted on computer tapes.
The proposed rule would update FDA's addresses in Sec. 607.22(a).
The proposal would also amend Sec. 607.22(b) to delete the language
concerning tapes for computer input and the submission of proposed
formats for FDA review and approval. FDA is proposing to delete this
provision because it has never been used.
[[Page 26335]]
5. Section 607.25--Information Required for Establishment Registration
and Blood Product Listing
Section 607.25(a), in describing FDA Form FD-2830, uses the words
``post office ZIP code.''
The proposal would revise Sec. 607.25(a) to refer to a post office
code. This change reflects the fact that many foreign countries do not
use the term ``ZIP'' code.
6. Section 607.26--Amendments to Establishment Registration
Section 607.26 requires changes in individual ownership,
``corporate or partnership structure location or blood-product handling
activity'' to be reported. This provision was intended to require,
among other things, firms to report changes in corporate or partnership
structure as well as changes in location, but was occasionally
misinterpreted as applying solely to changes in location.
Consequently, the proposal would revise this language to read as
``Changes in individual ownership, corporate or partnership structure,
location, or blood-product handling activity'' to clarify that changes
in corporate or partnership structure or location or blood-product
handling activity are to be reported.
7. Section 607.31--Additional Blood Product Listing Information
Section 607.31 describes additional information that FDA may
require by letter, but states that the Commissioner will perform
various actions, such as making a request or a finding, before
requiring the additional information.
The proposal would substitute the ``Director of the Center for
Biologics Evaluation and Research'' for the ``Commissioner'' throughout
Sec. 607.31(a) because the center director, rather than the
Commissioner, performs those functions.
The proposal would also delete the text in Sec. 607.31(b)
pertaining to the voluntary reporting of information on the quantity of
blood product distributed. FDA is proposing to delete the text in
paragraph (b) because the form specified in the rule, Form FD-2831
(Blood Establishment Resource Summary), is obsolete, and the provision
has not been used.
8. Section 607.35--Notification of Registrant; Blood Product
Establishment Registration Number and NDC Labeler Code
Section 607.35(a) currently states that the Commissioner will
provide a validated copy of form FD-2830 to the location shown for the
registering establishment.
The proposal would amend Sec. 607.35(a) to state that a copy will
also be sent to the reporting official if that official is at another
address. This would accommodate those employees or representatives who
submit registration and listing information for an establishment but
are not located at that establishment.
The proposal would also substitute the ``Director of the Center for
Biologics Evaluation and Research'' for the ``Commissioner'' because
the center director, rather than the Commissioner, performs that
function.
9. Section 607.37--Inspection of Establishment Registrations and Blood
Product Listings
Section 607.37 currently lists addresses where filed forms are
available for inspection or where requests for information regarding
blood establishment registration and listing should be sent.
The proposal would update the addresses.
10. Section 607.40--Establishment Registration and Blood Product
Listing Requirements for Foreign Blood Product Establishments
Currently, Sec. 607.40, entitled ``Blood product listing
requirements for foreign blood product establishments,'' requires such
establishments to comply with blood product listing requirements and
prohibits the importation of most nonlisted blood products. The
provision also requires foreign blood product establishments to submit
listing information in English and, as part of their listing, to submit
the name and address of the establishment and the name of the
individual responsible for submitting the product listing information.
Proposed Sec. 607.40(a) would require foreign establishments to
comply with establishment registration requirements in addition to
blood product listing requirements. To complement this change, the
proposal would revise the title to Sec. 607.40 to read as
``Establishment registration and blood product listing requirements for
foreign blood product establishments.''
Proposed Sec. 607.40(b) would enable FDA to prohibit the
importation of blood products from unregistered foreign establishments,
in addition to prohibiting the importation of unlisted blood products.
This prohibition would be similar to proposed Sec. 207.40(b) because
blood and blood products are ``drugs'' within the meaning of section
201(g) of the act. As stated earlier, the prohibition is consistent
with sections 301(p), 501(a), and 801(a) of the act because, if a
foreign establishment fails to register, FDA will be unable to
determine, through an establishment inspection, whether that foreign
establishment meets CGMP. Consequently, blood and blood products from
those establishments would appear to be adulterated under section
801(a)(3) of the act. Therefore, to enforce sections 301(p), 501(a),
and 801(a) of the act effectively, in conjunction with section 510(i)
of the act as it pertains to foreign establishment registration,
proposed Sec. 607.40(b) would prohibit the importation of blood
products that are not manufactured, prepared, propagated, compounded,
or processed at a registered foreign establishment.
Proposed Sec. 607.40(b) would also add establishment registration
information to types of information that must be submitted in the
English language.
Proposed Sec. 607.40(c) would require foreign blood product
establishments to submit the name and address of the establishment and
the name of the individual responsible for submitting the establishment
registration and product listing information as part of the
establishment registration and blood product listing. Proposed
Sec. 607.40(c) would also require foreign establishments to report any
changes in their registration or listing information.
Proposed Sec. 607.40(d) would require each foreign blood product
establishment to submit the name, address, and phone number of its
United States agent as part of its initial and updated registration
information. Each foreign blood product establishment would be
permitted to designate only one United States agent. Similar to
proposed Sec. 207.40(c), proposed Sec. 607.40(d) would require the
United States agent to reside or maintain a place of business in the
United States, and, upon request from FDA, assist FDA in communications
with the foreign establishment, respond to questions concerning
imported products, and assist FDA in scheduling inspections. Proposed
Sec. 607.40(d) would also enable FDA, when it is unable to contact the
foreign manufacturer directly or expeditiously, to provide information
or documents to the United States agent and for that act to be
considered equivalent to providing the same information or documents to
the foreign establishment. Changes to the United States agent's name,
address, or phone number would, under proposed Sec. 607.40(d), be
reported to FDA within 5 days of the change.
[[Page 26336]]
11. Section 607.65--Exemptions for Blood Product Establishments
Section 607.65 lists several classes of persons who are exempt from
registration and blood product listing under part 607. These
exemptions, which currently pertain only to domestic establishments,
reflect the statutory exemptions in section 510(g) of the act or
represent a finding by the agency that registration of such persons is
not necessary for the protection of the public health. For example,
Sec. 607.65(c) exempts persons who manufacture blood products solely
for use in research, teaching, or analysis. This exemption is
consistent with section 510(g)(3) of the act. Section 607.65(d) exempts
carriers who receive, carry, hold, or deliver blood products in their
usual course of business, while Sec. 607.65(e) exempts persons who
engage solely in the manufacture of in vitro diagnostic blood products
and reagents that are not subject to licensing under section 351 of the
Public Health Service Act (42 U.S.C. 262). FDA created the exemption in
Sec. 607.65(d) because registering these persons was not necessary to
protect the public health, whereas the exemption in Sec. 607.65(e)
exists because nonlicensed, in vitro diagnostic establishments are
subject to registration under part 807 instead of part 607.
The proposed rule would amend Sec. 607.65 so that paragraphs (c),
(d), and (e) would apply to both foreign and domestic persons or
establishments. Foreign persons or establishments would not be included
in the remaining exemptions in Sec. 607.65 because those exemptions
depend on compliance with Federal, State, or local laws in the United
States and its territories and because FDA has insufficient information
to make a finding, under section 510(g)(5) of the act, that
registration by such foreign establishments is not necessary to protect
the public health. For example, Sec. 607.65(a) pertains to pharmacies
operating under applicable local laws, while Sec. 607.65(b) pertains to
practitioners licensed by law. Notwithstanding the proposed rule's
limitation of these exemptions to pharmacies and practitioners in the
United States and its territories, few foreign pharmacies or foreign
practitioners are expected to be importing or offering for import blood
and blood products into the United States, so they would not be subject
to the foreign establishment registration requirement. As with the
similar requirement in proposed Sec. 207.10, those that do import or
offer to import such products to the United States should register to
allow FDA to carry out its oversight responsibilities in this area.
Similarly, Sec. 607.65(f) (transfusion services that are part of a
facility approved for Medicare reimbursement) and Sec. 607.65(g)
(clinical laboratories approved for Medicare reimbursement) both
involve establishments approved for Medicare reimbursement; the agency
does not anticipate that many foreign establishments are approved for
Medicare reimbursement. Consequently, FDA is not proposing to extend
these exemptions to foreign establishments and does not anticipate that
many foreign transfusion services or clinical laboratories will be
subject to the statutory registration requirement.
C. Proposed Changes to Part 807 (Devices)
1. Section 807.3--Definitions
a. Definition of ``commercial distribution''. Section 807.3(b)
currently defines ``commercial distribution,'' in part, as ``any
distribution of a device intended for human use which is held or
offered for sale * * *.''
Similar to the proposed changes to Secs. 207.3 and 607.3, the
proposed rule would create a new Sec. 807.3(b)(4) to state that, for
foreign establishments, commercial distribution does not include
distribution of a device that is neither imported nor offered for
import into the United States.
b. Definition of ``United States agent''. Currently, Sec. 807.3(r)
defines a ``U.S.-designated agent'' as a person, residing in the United
States, who is ``designated and authorized by the owner or operator of
a foreign manufacturer who exports devices into the United States'' and
who is responsible for submitting medical device reports and annual
certifications, acting as the official correspondent, and submitting
registration and listing information and premarket notifications. In
the Federal Register of July 23, 1996 (61 FR 38345), FDA stayed the
effective date for this and other provisions in part 807 (and
elsewhere) that mention a U.S.-designated agent.
The proposed rule would revise Sec. 807.3(r) to define a ``United
States agent'' as ``any person residing or maintaining a place of
business in the United States whom a foreign establishment designates
as its agent.'' As stated earlier, FDA interprets the statutory
requirement of a United States agent as allowing for only one United
States agent for each foreign establishment and providing a foreign
establishment the discretion to choose either an individual person or
entity to serve as its United States agent.
Additionally, unlike the existing provision, proposed Sec. 807.3(r)
would not prescribe any duties for the United States agent. Proposed
Sec. 807.40 would describe the United States agent's responsibilities
and is discussed later in this document.
2. Section 807.20--Who Must Register and Submit a Device List
Section 807.20(a) currently requires an ``owner or operator of an
establishment not exempt under section 510(g) of the act'' or subpart D
of part 807 who is engaged in the manufacture, preparation,
propagation, compounding, assembly, or processing of a device intended
for human use to register and to submit listing information. It also
states that an owner or operator shall register and list devices
``whether or not the output of the establishments or any particular
device so listed enters interstate commerce.'' Section 807.20 also
lists persons who are subject to the registration and listing
requirements; one paragraph, at Sec. 807.20(a)(6), refers to persons
who act as the ``U.S.-designated agent.''
The proposal would amend Sec. 807.20(a) to clarify that an owner or
operator ``shall'' register and list (unless it is otherwise exempt
from such requirements). The proposal would also clarify that the
language requiring owners and operators to register their
establishments and to list devices, even if the devices do not enter
interstate commerce, applies only to domestic firms. FDA is proposing
this change because the agency has no intent to require foreign
establishments to list devices that are not imported or offered for
import into the United States, consistent with the language in section
510(i)(1) of the act.
The proposal would also amend the heading of subpart B,
``Procedures for Domestic Device Establishments,'' to remove the word
``domestic.'' This would reflect the fact that the act's registration
and listing requirements now apply both to domestic establishments and
to foreign establishments whose devices are imported or offered for
import into the United States.
The proposal would also delete Sec. 807.20(a)(6) pertaining to
persons acting as the U.S.-designated agent. This deletion would
complement changes to Secs. 807.3 and 807.40 (discussed below) which
would give a foreign establishment discretion in defining most
responsibilities of its United States agent.
[[Page 26337]]
3. Section 807.25--Information Required or Requested for Establishment
Registration and Device Listing
Section 807.25 currently states that FDA Forms FD-2891 and 2891(a)
are the approved forms for establishment registration and device
listing and that the required information includes ``post office ZIP
Code.''
The proposal would change this to read as ``post office code''
because the term ``ZIP Code'' is not used in many foreign countries.
4. Section 807.40--Establishment Registration and Device Listing for
U.S. Agents of Foreign Establishments
Currently, Sec. 807.40 requires foreign device manufacturers who
export devices to the United States to designate a person as a ``U.S.-
designated agent.'' The U.S.-designated agent is responsible for duties
such as submitting medical device reports, submitting annual
certifications, acting as the manufacturer's official correspondent,
and submitting registration and listing information and premarket
notifications. The rule also directs foreign manufacturers to provide a
statement of authorization for the U.S.-designated agent to FDA.
However, in the Federal Register of July 23, 1996 (61 FR 38345), FDA
stayed the effective date of this provision.
The proposal would delete the existing language in Sec. 807.40
entirely and replace it with general descriptions of the foreign
establishment's obligations and the United States agent's role. The
proposal would also use the term ``foreign establishment,'' rather than
``foreign manufacturer,'' and revise the heading of Sec. 807.40 to be
more consistent with section 510 of the act.
Proposed Sec. 807.40(a) would require any foreign establishment
engaged in the manufacture, preparation, propagation, compounding, or
processing of a device that is imported or offered for import into the
United States to register and list its devices in conformance with
subpart B (``Procedures for Device Establishments''). This would have
foreign establishments comply with the same procedures as domestic
establishments.
The proposal would also require the official correspondent for the
foreign establishment to facilitate communication between the
establishment's management and FDA. This change complements the
requirement for an official correspondent in Sec. 807.25(d).
Proposed Sec. 807.40(b) would require each registered foreign
establishment to submit the name, address, and phone number of its
United States agent as part of its registration information. Under the
proposal, each foreign establishment would be able to designate only
one United States agent. The proposal would also require the agent to
reside or maintain a place of business in the United States, but would
allow (rather than require) a foreign establishment to designate its
United States agent as its official correspondent. Designating the
United States agent as the official correspondent may be more efficient
than having a separate United States agent and an official
correspondent, but the proposed rule would give foreign establishments
flexibility in deciding how to allocate their resources in this area
and what the United States agent's responsibilities would be.
FDA notes that electronic product manufacturers, under Sec. 1005.25
(21 CFR 1005.25), must designate a permanent resident of the United
States as the manufacturer's agent upon whom service of process may be
made for and on behalf of the manufacturer as provided in section
360(d) of the Radiation Control for Health and Safety Act of 1968.
Manufacturers of products that are both medical devices and electronic
products, therefore, may wish to consider whether their agents, under
Sec. 1005.25, can also serve as their United States agent under
proposed Sec. 807.40 and perform the duties expected of a United States
agent.
Like proposed Secs. 207.40 and 607.40, proposed Sec. 807.40(b) also
would require the United States agent, upon request from FDA, to assist
the agency in communications with the foreign establishment, to respond
to questions regarding devices imported or offered for import, and to
assist FDA in scheduling inspections of the foreign establishment.
Proposed Sec. 807.40(b) would also enable FDA, when it is unable to
contact the foreign manufacturer directly or expeditiously, to provide
information or documents to the United States agent and for that act to
be considered equivalent to providing the same information or documents
to the foreign establishment, and would further require a foreign
establishment to report to FDA changes in the United States agent's
name, address, or phone number within 5 days of the change.
Proposed Sec. 807.40(c), like proposed Secs. 207.40(b) and
607.40(b), would prohibit the importation of devices that have not been
listed or manufactured, prepared, propagated, compounded, or processed
at a registered foreign establishment. This provision is consistent
with the act in several respects. Under section 502(o) of the act, a
device that is not included in a list is misbranded, and section
801(a)(3) of the act authorizes FDA to refuse admission of misbranded
articles. Additionally, prohibiting imports from unregistered foreign
establishments is consistent with sections 301(p), 501(h), and 801(a)
of the act because, if a foreign establishment fails to register, FDA
will be unable to determine whether that foreign establishment meets
the requirements of the CGMP/quality systems regulation. (Section
501(h) of the act considers a device to be adulterated if the device
and the methods used in, or the facilities or controls used for, the
device's manufacture, packing, storage, or installation are not in
conformity with CGMP.) Consequently, to enforce sections 301(p),
501(h), and 801(a) of the act effectively, in conjunction with section
510(i) of the act as it pertains to foreign establishment registration,
proposed Sec. 807.40(c) would prohibit the importation of devices that
are not manufactured, prepared, propagated, compounded, or processed at
a registered foreign establishment. Such a requirement is therefore
authorized under section 701(a) of the act for the efficient
enforcement of the act.
D. Other Rules Affecting Establishment Registration and Listing
The proposed rule would also revise the authority citations for
parts 207 and 807 to be consistent with other regulations published by
the agency in the Federal Register of May 13, 1998 (63 FR 26690) and
May 14, 1998 (63 FR 26744). The former would amend various FDA
regulations to delete references to the certification of insulin and to
section 506 of the act (which was repealed by FDAMA), while the latter
would require establishment registration and listing for manufacturers
of human cellular and tissue-based products.
The proposal would also add sections 201, 801, and 903 of the act
(21 U.S.C. 393) to the authority citation for parts 207, 607, and 807.
Section 201 of the act contains definitions, such as the definition of
a ``State,'' and some definitions are relevant to these regulations.
Section 801 of the act provides authority over imports, whereas section
903 of the act establishes, among other things, FDA's mission and
interagency collaboration obligations.
The proposal would further revise the authority citation for part
607 by deleting the citation for 42 U.S.C. 216, and adding 42 U.S.C.
264 and 271. The former provision concerns regulatory authority
relating to commissioned corps members and is therefore
[[Page 26338]]
inapplicable to part 607, whereas the latter provisions provide
authority to issue regulations to control communicable disease and
establish penalties for violation of quarantine laws.
E. Registration Schedules
Because part 207 applies to human drugs, animal drugs, and some
biologics, FDA intends to develop a staggered schedule for foreign
establishment registration. In general, the registration schedule would
be similar in concept to Sec. 207.21 whereby firms whose name began
with a particular letter of the alphabet would register within a
specific month. For example, a firm whose name began with the letter
``a'' or ``b'' might be requested to register by January, whereas a
firm whose name began with the letter ``c'' might be requested to
register by February. The precise dates, however, may depend upon the
date on which FDA publishes a final rule in the Federal Register.
Therefore, FDA intends to announce the schedule for foreign
establishment registration for firms subject to part 207 in the
preamble to the final rule.
Comparatively fewer foreign manufacturers are subject to the
registration requirements in parts 607 and 807. Consequently, the
agency does not intend to develop any special registration schedules
for parts 607 and 807.
III. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is consistent with the principles set out in the
Executive Order. In addition, the proposed rule is a significant
regulatory action as defined in Executive Order 12866.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant economic impact
of a rule on small entities. FDA believes that the proposed rule will
not have a significant economic impact on a substantial number of small
entities, but has conducted an initial regulatory flexibility analysis
to ensure that impacts on small entities were assessed and to alert any
potentially impacted small entities to the opportunity to submit
comments to FDA.
The proposed rule would require foreign establishments that import
or offer for import human drugs, animal drugs, biologics, blood, blood
products, and devices into the United States to register and to
identify a United States agent. Before FDAMA amended section 510 of the
act to require foreign establishment registration, many foreign
establishments voluntarily registered their establishments, but all
foreign establishments that imported or offered for import drugs, blood
and blood products, and devices into the United States were required to
list their products. The registration and listing activities used forms
prepared by FDA. (FDA plans to revise these forms in the future to
provide for the identification of a United States agent by foreign
establishments.)
Because foreign establishments were (and still are) required to
list their products, FDA can estimate the number of foreign
establishments that would be required to register under the proposed
rule. However, because all of these establishments are outside the
United States, FDA is unable to estimate accurately the number of
foreign establishments that would be considered small entities and the
extent to which these foreign establishments conduct business in the
United States.
Nevertheless, FDA is able to estimate the proposed rule's economic
impact by using time and cost estimates for registration. FDA estimates
the costs associated with establishment registration are small, ranging
from $20 per hour for device establishments, $25 per hour for blood and
blood product establishments, and $100 per hour for drug
establishments. These costs are based on information obtained primarily
from domestic establishments, and FDA is assuming that the average
costs for foreign establishments will be similar. FDA also estimates
that completing an establishment registration form will range from 15
minutes to 1 hour (depending on the form used). These estimates are
derived from the estimated registration costs for domestic
establishments and foreign establishments that voluntarily registered
before FDAMA's enactment. Thus, the proposed rule, if finalized, should
not have a significant economic impact on a substantial number of small
entities.
The agency examined, but rejected, alternatives to the proposed
rule. The registration information required by FDA in the proposal is
minimal, consisting largely of the establishment's address, names of
owners or responsible officials, and additional identifying information
on the establishment (such as type of establishment, types of products
at the establishment, type of ownership). Similarly, identification of
the United States agent would require minimal information (name,
address, phone number). An alternative that required less information
from foreign establishments would not provide sufficient information to
identify the foreign establishment's location, a responsible person at
the foreign establishment, or the type of establishment, thereby
complicating any effort to locate or contact the foreign establishment
or to determine whether the foreign establishment complied with the
appropriate statutory and regulatory requirements. An alternative that
required less frequent reporting by foreign establishments was rejected
because it would increase the likelihood that the information possessed
by FDA would be incorrect or obsolete and hinder the conduct of
regulatory actions involving foreign establishments.
The Unfunded Mandates Reform Act (Pub. L. 104-114) requires that
agencies prepare an assessment of anticipated costs and benefits before
proposing any rule that may result in an expenditure in any 1 year by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100 million or more (adjusted annually for
inflation). FDA estimates that the reporting costs for industry under
the proposed rule would total $809,820. This estimate is based on
annual projections of 4,160.5 hours for drug industry reports, 108.5
hours for blood and blood product reports, and 15,664 hours for device
reports, multiplied by hourly industry costs of $100, $20, and $25 per
report respectively. The estimated recordkeeping cost to industry is
$810,000, based on an estimated 32,400 records at $25 per hour. Thus,
because the total expenditures under the proposal will not result in a
1-year expenditure of $100 million or more, FDA is not required to
perform a cost-benefit analysis under the Unfunded Mandates Reform Act.
IV. Environmental Impact
The agency has determined, under 21 CFR 25.30(h), that this action
is of a type that does not individually or cumulatively have a
significant effect on the human environment. Therefore, neither an
environmental assessment nor an environmental impact statement is
required.
[[Page 26339]]
V. Paperwork Reduction Act of 1995
This proposed rule contains information collection provisions that
are subject to public comment and review by OMB under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3520). The title, description,
and respondent description for the information collection requirements
are shown below with an estimate of the annual reporting and
recordkeeping burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
Title: Foreign Establishment Registration and Listing.
Description: The proposed rule would require foreign establishments
that import or offer to import human drugs, animal drugs, biologics,
blood products, and devices into the United States to register and to
name a United States agent. This information is required by section
510(i)(1) of the act, as amended by section 417 of FDAMA.
Although section 510(i)(2) of the act also requires foreign
establishments to list their products at FDA, the proposed rule does
not include such a requirement because FDA's existing regulations
already require foreign manufacturers to submit such lists, and the
agency has already obtained OMB approval for the information collection
burden associated with product listing for parts 207 and 607 (for part
207, the OMB approval number is 0910-0045 and expires on April 30,
2001; for part 607, the OMB approval number is 0910-0052 and expires on
April 30, 2000). Through this notice, FDA is also seeking approval for
the device listing requirements insofar as they will be applied to
foreign establishments.
Description of Respondents: Persons and businesses, including small
businesses.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden1
----------------------------------------------------------------------------------------------------------------
No. of
21 CFR Section No. of Responses per Total Annual Hours per Total Hours
Respondents Respondent Responses Response
----------------------------------------------------------------------------------------------------------------
207.21(a) 2,463 1 2,463 0.5 1,231.5
207.22(a) and 207.40 5,630 1 5,630 0.5 2,815
207.25(b) 53 4.8 228 0.5 114
607.22(a) and 607.40 98 1 98 1 98
607.26 1 1 1 0.5 0.5
607.31 1 1 1 10 10
807.22(a) and 807.40 7,200 1 7,200 0.25 1,800
807.22(b) 27,720 1 27,720 0.5 13,860
807.31(e) 7 1 7 0.5 4
Total 19,933
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2.--Estimated Annual Recordkeeping Burden1
----------------------------------------------------------------------------------------------------------------
No. of Records
21 CFR Section No. of per Total Annual Hours per Total Hours
Recordkeepers Recordkeeper Records Record
----------------------------------------------------------------------------------------------------------------
807.31 6,480 10 64,800 0.5 32,400
Total 32,400
----------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.
In general, FDA based the above estimates on the number of foreign
establishments that currently list drugs, blood products, or devices
(as required by existing FDA regulations) and on comparable burden hour
estimates for registration by domestic establishments. Accordingly,
FDA's estimate of 30 minutes for each initial drug report
(Sec. 207.22), 1 hour for each initial biologic report (Sec. 607.22),
45 minutes for each device report (Sec. 807.22), and 30 minutes for
each additional report submitted (Sec. 807.31) is consistent with
current practices.
For proposed Secs. 207.21(a) and 207.25(b), the agency estimated
the number of respondents submitting ANDA's or ANADA's from the number
of establishments submitting listing information. For proposed
Sec. 207.21(a), FDA's drug listing records indicate that there are
2,410 firms submitting ANDA's and 53 firms submitting ANADA's, for a
total of 2,463 respondents. The proposed rule would amend
Sec. 207.25(b) to include ANADA's, and FDA records indicate that 228
ANADA's were submitted; consequently, the total number of respondents
is 53, with a total of 228 annual responses. The estimated total annual
responses and hours per response are consistent with existing figures
for other establishments subject to Secs. 207.21 and 207.25.
For proposed Secs. 607.26 and 607.31, FDA's experience reveals that
only one establishment has reported information under these provisions
in recent years. Therefore, the agency assigned an estimate of one
respondent for each provision. The agency estimated the burden hours
for these provisions by examining their complexity. Because proposed
Sec. 607.26 would require reporting changes in individual
[[Page 26340]]
ownership, corporate or partnership structure, location, or blood-
product handling activity, the agency assigned 30 minutes as the
reporting burden. In contrast, Sec. 607.31 authorizes the agency to
request additional information by letter. FDA has made no requests in
recent years, but has assigned 10 hours as a reporting burden for this
provision.
The estimated recordkeeping burden for proposed Sec. 807.31 is
based on FDA's experience with foreign device establishments. FDA's
experience indicates that there are approximately 9 owners or operators
for every 10 foreign device establishments. Consequently, the estimated
number of recordkeepers is 6,480 (7,200 x 0.9 = 6,480), and the average
frequency and average burden per record, based on comparable figures
for domestic establishments, are 10 and 30 minutes respectively. This
results in a total recordkeeping burden of 32,400 hours (6,480
recordkeepers x 10 records per recordkeeper x 0.5 hours per record =
32,400 hours).
In compliance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3507(d)), the agency has submitted the information
collection requirements of this proposed rule to OMB for review.
Interested persons are requested to send comments regarding information
collection by June 14, 1999, to the Office of Information and
Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW.,
Washington, DC 20503, Attn: Wendy Taylor, Desk Officer for FDA.
List of Subjects
21 CFR Part 207
Drugs, Reporting and recordkeeping requirements.
21 CFR Part 607
Blood.
21 CFR Part 807
Confidential business information, Imports, Medical devices,
Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR parts 207, 607, and 807 be amended as follows:
PART 207--REGISTRATION OF PRODUCERS OF DRUGS AND LISTING OF DRUGS
IN COMMERCIAL DISTRIBUTION
1. The authority citation for part 21 CFR part 207 is revised to
read as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 360b, 371,
374, 381, 393; 42 U.S.C. 262, 264, 271.
2. Section 207.3 is amended by revising paragraph (a)(5) and by
adding paragraph (a)(11) to read as follows:
Sec. 207.3 Definitions.
(a) * * *
(5) Commercial distribution means any distribution of a human drug
except for investigational use under part 312 of this chapter, and any
distribution of an animal drug or animal feed bearing or containing an
animal drug for noninvestigational uses, but the term does not include
internal or interplant transfer of a bulk drug substance between
registered establishments within the same parent, subsidiary, and/or
affiliate company. For foreign establishments, the term ``commercial
distribution'' shall have the same meaning except that the term shall
not include distribution of any drug that is neither imported nor
offered for import into the United States.
* * * * *
(11) United States agent means a person residing or maintaining a
place of business in the United States whom a foreign establishment
designates as its agent.
* * * * *
3. Section 207.7 is amended by revising paragraph (a) to read as
follows:
Sec. 207.7 Establishment registration and product listing for human
blood and blood products and for medical devices.
(a) Owners and operators of human blood and blood product
establishments shall register and list their products with the Center
for Biologics Evaluation and Research (HFM-375), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448, on Form FDA-2830 (Blood Establishment Registration and Product
Listing), in accordance with part 607 of this chapter. Such owners and
operators who also manufacture or process other drug products at the
same establishment shall, in addition, register and list all such other
drug products with the Drug Listing Branch in accordance with this
part.
* * * * *
4. Section 207.10 is amended by revising the section heading and
the introductory text to read as follows:
Sec. 207.10 Exemptions for establishments.
The following classes of persons are exempt from registration and
drug listing in accordance with this part under section 510(g)(1),
(g)(2), and (g)(3) of the act, or because FDA has found, under section
510(g)(5), that their registration is not necessary for the protection
of the public health. The exemptions in paragraphs (a) and (b) of this
section are limited to pharmacies, hospitals, clinics, and public
health agencies located in any State as defined in section 201(a)(1) of
the act.
* * * * *
5. Section 207.20 is amended by revising paragraphs (a) and (c) to
read as follows:
Sec. 207.20 Who must register and submit a drug list.
(a) Owners or operators of all drug establishments, not exempt
under section 510(g) of the act or subpart B of this part 207, that
engage in the manufacture, preparation, propagation, compounding, or
processing of a drug or drugs shall register and submit a list of every
drug in commercial distribution (except that listing information may be
submitted by the parent, subsidiary, and/or affiliate company for all
establishments when operations are conducted at more than one
establishment and there exists joint ownership and control among all
the establishments). Drug listing is not required for the
manufacturing, preparation, propagation, compounding, or processing of
an animal feed bearing or containing an animal drug (i.e., a Type B or
Type C medicated feed), nor is drug listing required for establishments
engaged in drug product salvaging. Drug products manufactured,
prepared, propagated, compounded, or processed in any State as defined
in section 201(a)(1) of the act must be listed whether or not the
output of such establishments or any particular drug so listed enters
interstate commerce. No owner or operator may register an establishment
if any part of the establishment is registered by any other owner or
operator.
* * * * *
(c) Before beginning manufacture or processing of a drug subject to
one of the following applications, an owner or operator of an
establishment is required to register before the agency approves it: A
new drug application, an abbreviated new drug application, a new animal
drug application, an abbreviated new animal drug application, a
medicated feed application, or a biologics license application.
* * * * *
Sec. 207.21 [Amended]
6. Section 207.21 Times for registration and drug listing is
amended in the second sentence of paragraph (a) by adding the phrase
``abbreviated new drug application,'' after the phrase ``new drug
application,'' and by adding the
[[Page 26341]]
phrase ``abbreviated new animal drug application,'' after the phrase
``new animal drug application,''.
Sec. 207.25 [Amended]
7. Section 207.25 Information required in registration and drug
listing is amended in paragraph (b)(2) by adding the phrase
``abbreviated new animal drug application number,'' after the phrase
``new animal drug application number,''.
8. Section 207.37 is amended by revising the introductory text of
paragraph (a) and by revising paragraph (b) to read as follows:
Sec. 207.37 Inspection of registrations and drug listings.
(a) A copy of the Form FDA-2656 (Registration of Drug
Establishment) filed by the registrant will be available for inspection
in accordance with section 510(f) of the act, at the Division of
Labeling and Non-Prescription Drug Compliance (HFD-310), Office of
Compliance, Center for Drug Evaluation and Research, Food and Drug
Administration, 7520 Standish Pl., Rockville, MD 20855. In addition,
copies of these forms for establishments located within a particular
geographic area are available for inspection at FDA district offices
responsible for that geographical area. Copies of forms submitted by
foreign drug establishments are available for inspection at the Foreign
Inspection Team (HFD-322), Office of Compliance, Center for Drug
Evaluation and Research, Food and Drug Administration, 7520 Standish
Pl., Rockville, MD 20855. Upon request and receipt of a stamped, self-
addressed envelope, the Division of Labeling and Non-Prescription Drug
Compliance, the Foreign Inspection Team, or the appropriate FDA
district office will verify registration numbers or provide the
location of a registered establishment.
* * * * *
(b) Requests for information about registrations and drug listings
of an establishment should be directed to the Information Management
Team (HFD-095), Office of Information Technology, Center for Drug
Evaluation and Research, Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857 or, with respect to the information described
in paragraph (a) of this section, to the FDA district office
responsible for the geographic area in which the establishment is
located.
9. Section 207.40 is revised to read as follows:
Sec. 207.40 Establishment registration and drug listing requirements
for foreign drug establishments.
(a) Foreign drug establishments whose drugs are imported or offered
for import into the United States shall comply with the establishment
registration and drug listing requirements in subpart C of this part,
unless exempt under subpart B of this part.
(b) No drug, unless it is listed as required in subpart C of this
part and manufactured, prepared, propagated, compounded, or processed
at a registered foreign drug establishment, may be imported or offered
for import into the United States except a drug imported or offered for
import under the investigational use provisions in part 312 of this
chapter. Foreign drug establishments shall submit all listing
information, including labels and labeling, and registration
information in the English language.
(c) Each foreign drug establishment required to register under
paragraph (a) of this section shall submit the name, address, and phone
number of its United States agent as part of its initial and updated
registration information in accordance with subpart C of this part.
Each foreign drug establishment shall designate only one United States
agent.
(1) The United States agent shall reside or maintain a place of
business in the United States.
(2) Upon request from FDA, the United States agent shall assist FDA
in communications with the foreign drug establishment, respond to
questions concerning the foreign drug establishment's products that are
imported or offered for import into the United States, and assist FDA
in scheduling inspections of the foreign drug establishment. If the
agency is unable to contact the foreign drug establishment directly or
expeditiously, FDA may provide information or documents to the United
States agent, and such an action shall be considered to be equivalent
to providing the same information or documents to the foreign drug
establishment.
(3) The foreign drug establishment shall report changes in the
United States agent's name, address, or phone number to FDA within 5
days of the change.
PART 607--ESTABLISHMENT REGISTRATION AND PRODUCT LISTING FOR
MANUFACTURERS OF HUMAN BLOOD AND BLOOD PRODUCTS
10. The authority citation for 21 CFR part 607 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 355, 360, 371, 374,
381, 393; 42 U.S.C. 262, 264, 271.
11. Section 607.3 is amended by revising paragraph (e) and by
adding paragraph (j) to read as follows:
Sec. 607.3 Definitions.
* * * * *
(e) Commercial distribution means any distribution of a blood
product except pursuant to the investigational use provisions of part
312 of this chapter, but does not include internal or interplant
transfer of a bulk product substance between registered establishments
within the same parent, subsidiary, and/or affiliate company. For
foreign establishments, the term ``commercial distribution'' shall have
the same meaning except that the term shall not include distribution of
any blood or blood product that is neither imported nor offered for
import into the United States.
* * * * *
(j) United States agent means a person residing or maintaining a
place of business in the United States whom a foreign establishment
designates as its agent.
12. Section 607.7 is amended by revising paragraphs (b) and (c) to
read as follows:
Sec. 607.7 Establishment registration and product listing of blood
banks and other firms manufacturing human blood and blood products.
* * * * *
(b) Forms for registration of an establishment are obtainable on
request from the Center for Biologics Evaluation and Research (HFM-
375), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448, or at any of the Food and Drug Administration
district offices.
(c) The completed form should be mailed to the Center for Biologics
Evaluation and Research (HFM-375), Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448.
13. Section 607.20 is amended by revising paragraph (a) to read as
follows:
Sec. 607.20 Who must register and submit a blood product list.
(a) Owners or operators of all establishments, not exempt under
section 510(g) of the act or subpart D of this part 607, that engage in
the manufacture of blood products shall register and submit a list of
every blood product in commercial distribution (except that listing
information may be submitted by the parent, subsidiary, and/or
affiliate company for all establishments when operations are conducted
at more than one establishment and there exists joint
[[Page 26342]]
ownership and control among all the establishments). Blood products
manufactured, prepared, propagated, compounded, or processed in any
State as defined in section 201(a)(1) of the act must be listed whether
or not the output of such blood product establishment or any particular
blood product so listed enters interstate commerce.
* * * * *
14. Section 607.22 is revised to read as follows:
Sec. 607.22 How and where to register establishments and list blood
products.
(a) The first registration of an establishment shall be on Form FD-
2830 (Blood Establishment Registration and Product Listing) obtainable
on request from the Center for Biologics Evaluation and Research (HFM-
375), Food and Drug Administration, 1401 Rockville Pike, suite 200N,
Rockville, MD 20852-1448, or from Food and Drug Administration district
offices. Subsequent annual registration shall also be accomplished on
Form FD-2830 which will be furnished by the Food and Drug
Administration before November 15 of each year to establishments whose
product registration for that year was validated pursuant to
Sec. 607.35. The completed form shall be mailed to the above address
before December 31 of that year.
(b) The first list of blood products and subsequent June and
December updatings shall be on Form FD-2830, obtainable upon request as
described in paragraph (a) of this section.
Sec. 607.25 [Amended]
15. Section 607.25 Information required for establishment
registration and blood product listing is amended in the second
sentence of paragraph (a) by removing the word ``ZIP''.
16. Section 607.26 is amended by revising the first sentence to
read as follows:
Sec. 607.26 Amendments to establishment registration.
Changes in individual ownership, corporate or partnership
structure, location, or blood-product handling activity shall be
submitted on Form FD-2830 (Blood Establishment Registration and Product
Listing) as an amendment to registration within 5 days of such changes.
* * *
17. Section 607.31 is amended by revising paragraph (a) and by
removing and reserving paragraph (b) to read as follows:
Sec. 607.31 Additional blood product listing information.
(a) In addition to the information routinely required by
Secs. 607.25 and 607.30, the Director of the Center for Biologics
Evaluation and Research may require submission of the following
information by letter or by Federal Register notice:
(1) For a particular blood product so listed, upon request made by
the Director of the Center for Biologics Evaluation and Research for
good cause, a copy of all advertisements.
(2) For a particular blood product so listed, upon a finding by the
Director of the Center for Biologics Evaluation and Research that it is
necessary to carry out the purposes of the act, a quantitative listing
of all ingredients.
(3) For each registrant, upon a finding by the Director of the
Center for Biologics Evaluation and Research that it is necessary to
carry out the purposes of the act, a list of each listed blood product
containing a particular ingredient.
(b) [Reserved]
18. Section 607.35 is amended by revising paragraph (a) to read as
follows:
Sec. 607.35 Notification of registrant; blood product establishment
registration number and NDC Labeler Code
(a) The Director of the Center for Biologics Evaluation and
Research will provide to the registrant a validated copy of Form FD-
2830 (Blood Establishment Registration and Product Listing) as evidence
of registration. This validated copy will be sent to the location shown
for the registering establishment, and a copy will be sent to the
reporting official if at another address. A permanent registration
number will be assigned to each blood product establishment registered
in accordance with the regulations of this subpart.
* * * * *
19. Section 607.37 is amended by revising the introductory text of
paragraph (a) and by revising paragraph (b) to read as follows:
Sec. 607.37 Inspection of establishment registrations and blood
product listings.
(a) A copy of the Form FD-2830 (Blood Establishment Registration
and Product Listing) filed by the registrant will be available for
inspection pursuant to section 510(f) of the act, at the Office of
Communication, Training and Manufacturers' Assistance (HFM-40), Center
for Biologics Evaluation and Research, Food and Drug Administration,
1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448. In addition,
for domestic firms, the same information will be available for
inspection at each of the Food and Drug Administration district offices
for firms within the geographical area of such district office. Upon
request and receipt of a self-addressed stamped envelope, verification
of registration number, or location of registered establishment will be
provided. The following information submitted pursuant to the blood
product listing requirements is illustrative of the type of information
that will be available for public disclosure when it is compiled:
* * * * *
(b) Requests for information regarding blood establishment
registrations and blood product listings should be directed to the
Office of Communication, Training and Manufacturers' Assistance (HFM-
40), Center for Biologics Evaluation and Research, Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448.
20. Section 607.40 is revised to read as follows:
Sec. 607.40 Establishment registration and blood product listing
requirements for foreign blood product establishments.
(a) Every foreign establishment shall comply with the establishment
registration and blood product listing requirements contained in
subpart B of this part, unless exempt under subpart D of this part.
(b) No blood product may be imported or offered for import into the
United States except a blood product imported or offered for import
pursuant to the investigational use provisions of part 312 of this
chapter, unless it is the subject of a blood product listing as
required under subpart B of this part and is manufactured, prepared,
propagated, compounded, or processed at a registered foreign
establishment. The establishment registration and blood product listing
information shall be in the English language.
(c) Each foreign establishment required to register under paragraph
(a) of this section shall, as part of the establishment registration
and blood product listing, submit the name and address of the
establishment and the name of the individual responsible for submitting
establishment registration and blood product listing information. Any
changes in this information shall be reported to the Food and Drug
Administration at the intervals specified for updating establishment
registration information in Sec. 607.26 and blood product listing
information in Sec. 607.30(a).
(d) Each foreign establishment required to register under paragraph
(a) of this section shall submit the name, address, and phone number of
its United States agent as part of its initial and updated registration
information in
[[Page 26343]]
accordance with subpart B of this part. Each foreign establishment
shall designate only one United States agent.
(1) The United States agent shall reside or maintain a place of
business in the United States.
(2) Upon request from FDA, the United States agent shall assist FDA
in communications with the foreign establishment, respond to questions
concerning the foreign establishment's products that are imported or
offered for import into the United States, and assist FDA in scheduling
inspections of the foreign establishment. If the agency is unable to
contact the foreign establishment directly or expeditiously, FDA may
provide information or documents to the United States agent, and such
an action shall be considered to be equivalent to providing the same
information or documents to the foreign establishment.
(3) The foreign establishment shall report changes in the United
States agent's name, address, or phone number to FDA within 5 days of
the change.
21. Section 607.65 is amended by revising the introductory text to
read as follows:
Sec. 607.65 Exemptions for blood product establishments.
The following classes of persons are exempt from registration and
blood product listing in accordance with this part 607 under the
provisions of section 510(g)(1), (g)(2), and (g)(3) of the act, or
because the Commissioner has found, under section 510(g)(4), that such
registration is not necessary for the protection of the public health.
The exemptions in paragraphs (a), (b), (f), and (g) of this section are
limited to those classes of persons located in any State as defined in
section 201(a)(1) of the act.
* * * * *
PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR
MANUFACTURERS AND DISTRIBUTORS OF DEVICES
22. The authority citation for 21 CFR part 807 is revised to read
as follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i,
360j, 371, 374, 381, 393; 42 U.S.C. 264, 271.
23. Section 807.3 is amended by revising paragraphs (b) and (r) to
read as follows:
Sec. 807.3 Definitions.
* * * * *
(b) Commercial distribution means any distribution of a device
intended for human use which is held or offered for sale but does not
include the following:
(1) Internal or interplant transfer of a device between
establishments within the same parent, subsidiary, and/or affiliate
company;
(2) Any distribution of a device intended for human use which has
in effect an approved exemption for investigational use pursuant to
section 520(g) of the act and part 812 of this chapter;
(3) Any distribution of a device, before the effective date of part
812 of this chapter, that was not introduced or delivered for
introduction into interstate commerce for commercial distribution
before May 28, 1976, and that is classified into class III under
section 513(f) of the act: Provided, That the device is intended solely
for investigational use, and under section 501(f)(2)(A) of the act the
device is not required to have an approved premarket approval
application as provided in section 515 of the act; or
(4) For foreign establishments, the distribution of any device that
is neither imported nor offered for import into the United States.
* * * * *
(r) United States agent means a person residing or maintaining a
place of business in the United States whom a foreign establishment
designates as its agent.
* * * * *
24. The heading to subpart B ``Procedures for Domestic Device
Establishments'' is revised to read as follows:
Subpart B--Procedures for Device Establishments
25. Section 807.20 is amended by revising paragraph (a) to read as
follows:
Sec. 807.20 Who must register and submit a device list.
(a) An owner or operator of an establishment not exempt under
section 510(g) of the act or subpart D of this part who is engaged in
the manufacture, preparation, propagation, compounding, assembly, or
processing of a device intended for human use shall register and submit
listing information for those devices in commercial distribution,
except that listing information may be submitted by the parent,
subsidiary, or affiliate company for all the domestic or foreign
establishments under the control of one of these organizations when
operations are conducted at more than one establishment and there
exists joint ownership and control among all the establishments. The
term ``device'' includes all in vitro diagnostic products and in vitro
diagnostic biological products not subject to licensing under section
351 of the Public Health Service Act. An owner or operator of an
establishment located in any State as defined in section 201(a)(1) of
the act shall register its name, places of business, and all
establishments and list the devices whether or not the output of the
establishments or any particular device so listed enters interstate
commerce. The registration and listing requirements shall pertain to
any person who:
(1) Initiates or develops specifications for a device that is to be
manufactured by a second party for commercial distribution by the
person initiating specifications;
(2) Manufactures for commercial distribution a device either for
itself or for another person. However, a person who only manufactures
devices according to another person's specifications, for commercial
distribution by the person initiating specifications, is not required
to list those devices;
(3) Repackages or relabels a device;
(4) Acts as an initial importer; or
(5) Manufactures components or accessories which are ready to be
used for any intended health-related purpose and are packaged or
labeled for commercial distribution for such health-related purpose,
e.g., blood filters, hemodialysis tubing, or devices which of necessity
must be further processed by a licensed practitioner or other qualified
person to meet the needs of a particular patient, e.g., a manufacturer
of ophthalmic lens blanks.
* * * * *
Sec. 807.25 [Amended]
26. Section 807.25 Information required or requested for
establishment registration and device listing is amended in the last
sentence of paragraph (a) by removing the word ``ZIP''.
27. Section 807.40 is revised to read as follows:
Sec. 807.40 Establishment registration and device listing for foreign
establishments importing or offering for import devices into the United
States.
(a) Any establishment within any foreign country engaged in the
manufacture, preparation, propagation, compounding, or processing of a
device that is imported or offered for import into the United States
shall register and list such devices in conformance with the
requirements in subpart B of this part. The official correspondent for
the foreign establishment shall facilitate communication between the
foreign establishment's management and
[[Page 26344]]
representatives of the Food and Drug Administration.
(b) Each foreign establishment required to register under paragraph
(a) of this section shall submit the name, address, and phone number of
its United States agent as part of its initial and updated registration
information in accordance with subpart B of this part. Each foreign
establishment shall designate only one United States agent and may
designate the United States agent to act as its official correspondent.
(1) The United States agent shall reside or maintain a place of
business in the United States.
(2) Upon request from FDA, the United States agent shall assist FDA
in communications with the foreign establishment, respond to questions
concerning the foreign establishment's products that are imported or
offered for import into the United States, and assist FDA in scheduling
inspections of the foreign establishment. If the agency is unable to
contact the foreign establishment directly or expeditiously, FDA may
provide information or documents to the United States agent, and such
an action shall be considered to be equivalent to providing the same
information or documents to the foreign establishment.
(3) The foreign establishment shall report changes in the United
States agent's name, address, or phone number to FDA within 5 days of
the change.
(c) No device may be imported or offered for import into the United
States except a device imported or offered for import pursuant to the
investigational use provisions of part 812 of this chapter, unless it
is the subject of a device listing as required under subpart B of this
part and is manufactured, prepared, propagated, compounded, or
processed at a registered foreign establishment. The establishment
registration and device listing information shall be in the English
language.
Dated: January 26, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-12040 Filed 5-13-99; 8:45 am]
BILLING CODE 4160-01-F