[Federal Register Volume 69, Number 227 (Friday, November 26, 2004)]
[Proposed Rules]
[Pages 68831-68838]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-26234]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Chapter 1
[Docket No. 2002N-0434]
Withdrawal of Certain Proposed Rules and Other Proposed Actions
AGENCY: Food and Drug Administration, HHS.
ACTION: Withdrawal of proposed rules.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
withdrawal of certain advance notice of proposed rulemakings (ANPRMs),
proposed rules, and other proposed actions that published in the
Federal Register more than 5 years ago. These proposals are no longer
considered viable candidates for final action at this time. FDA is
taking this action to reduce its regulatory backlog and focus its
resources on current public health issues. The FDA's actions are part
of an overall regulatory reform strategy initiated by Health and Human
Services (HHS) Secretary Tommy G. Thompson.
DATES: The proposed rules are withdrawn as of November 26, 2004.
FOR FURTHER INFORMATION CONTACT: Lisa M. Helmanis, Regulations Policy
and Management Staff (HF-26), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-827-3480.
SUPPLEMENTARY INFORMATION:
I. Background
On June 8, 2001, Secretary Thompson announced his regulatory reform
initiative designed to reduce regulatory burdens in health care and
respond faster to the concerns of health care providers, State and
local governments, and individual Americans who are affected by HHS
rules. In December 2001, the Secretary announced the membership of his
Regulatory Reform Committee designed to carry out his initiative. In
November 2002, the Committee released its final report with over 255
specific recommendations for simplifying, streamlining, and generally
reducing the regulatory burden while
[[Page 68832]]
continuing to require accountability by those doing business with HHS
and its agencies. Over 25 of the recommendations have been adopted, and
the Secretary charged the Office of the Assistant Secretary for
Planning and Evaluation to continue the efforts of the Regulatory
Reform Committee. FDA's continuing efforts to finalize or withdraw
regulations that have been proposed but not finalized are part of this
overall initiative.
In 1990, FDA began this process of conducting periodic,
comprehensive reviews of its regulations process that included
reviewing the backlog of ANPRMs, notices of proposed rulemaking, and
other notices for which no final action or withdrawal notice had been
issued. In the Federal Register of December 30, 1991 (56 FR 67440), FDA
issued its first notice withdrawing 89 proposed rules that had
published before December 31, 1985, but had never been finalized. Then
again, in the Federal Register of January 20, 1994 (59 FR 3042), the
agency withdrew an additional nine outstanding proposed rules.
Once again, on April 22, 2003, FDA published a notice in the
Federal Register (68 FR 19766) announcing its intent to withdraw 84
proposed rules and other proposed actions that had published in the
Federal Register more than 5 years ago, but that had never been
finalized. Included in this list were 19 proposed rules that were
originally proposed for withdrawal in 1991, but at that time the agency
decided to defer its decision to withdraw or finalize them until a
later date.
The agency undertook this most recent review because it believes
that the backlog of pending proposals dilutes its ability to
concentrate on higher priority regulations that are mandated by statute
or are necessary to address current public health issues. Because of
the agency's limited resources and changing priorities, FDA has been
unable to: (1) Consider, in a timely manner, the issues raised by the
comments on these proposals and (2) complete the action on them.
Additionally, because many of the proposals have become outdated in the
time that has elapsed since their publication, the agency would need to
obtain further comment on them before proceeding to final action. FDA
has determined that the proposals identified in this document are lower
in priority than those on the Unified Agenda and the Regulatory Plan.
It is unlikely that the agency will have sufficient resources in the
foreseeable future to further consider or prioritize these proposed
rules. Although not required to do so by the Administrative Procedure
Act or by regulations of the Office of the Federal Register, the agency
believes the public interest is best served by withdrawing the
proposals identified in this document. In some instances, the agency
has already completed action on alternatives (e.g., the issuance of
guidance or inclusion of provisions in related regulations) that have
obviated the need to complete the proposed action. In addition, the
agency notes that upon reviewing the comments and other records related
to the rulemaking, the agency found that ``Amend Animal Care
Regulations'' (Docket No. 89P-0320 (July 3, 1990, 55 FR 27476)) was the
subject of a petition, and the agency assigned another docket number to
that action. This action was finalized on July 15, 1991 (56 FR 32087),
and therefore it is not necessary to be included in this withdrawal
notice.
The withdrawal of the proposals identified in this document does
not preclude the agency from reinstituting proceedings to issue rules
concerning the issues addressed in the proposals listed in table 1 of
this document. Should FDA decide to undertake such a rulemaking
sometime in the future, it will repropose the actions and provide new
opportunities for comment.
The agency notes that withdrawal of a proposal is not intended to
affect whatever utility the preamble statements may currently have as
indications of FDA's position on a matter at the time the proposal was
published, and in some cases the preambles of these proposals may still
reflect the current position of FDA on the matter addressed. Anyone
unsure whether a statement in one of the preambles reflects the
agency's current thinking should contact FDA.
II. Summary of and Responses to Comments
FDA received a total of 37 letters, each containing 1 or more
comments, in response to its notice of intent to withdraw certain
proposed rules. The following is a discussion of the comments and the
agency's response to those comments.
A. General Comments
(Comment 1) One comment provided recommendations on FDA's overall
withdrawal process and the way information in the notice of intent was
presented to the public. The comment requested that the agency identify
how it intended to handle each individual item included in the notice
of intent including reasons for withdrawal and future actions. The
comment also requested that the agency identify which preambles will
continue to reflect the agency's current thinking even after the
proposed rule has been withdrawn. Finally, the comment thought that FDA
should have made all the proposed actions listed in the notice of
intent available on FDA's Web site for easy access to all interested
parties.
(Response) The agency disagrees with these comments. The agency's
decisions on the items proposed to be withdrawn were based on the
general factors described in the notice of intent and whether the
proposals fell within the listed factors. When the agency published the
notice of intent, it did not have definite future plans for any of the
items listed. The reason the agency stated that it may take future
action was to emphasize that the withdrawals were based on resources
and priorities. A withdrawal does not prevent the agency from taking
action in the future on its own initiative or as a result of being
prompted by the public. Also, a withdrawal of a proposed rule neither
affirms nor rejects the views contained in the preamble. If someone
wants a clarification of any agency policy or position, they should
contact FDA.
While not providing copies on its Web site, the agency provided the
title, docket number, and Federal Register publication date and cite.
The agency believes that, in most cases, this information was
sufficient to allow readers to find the documents whether online or in
a library. Also, the agency provided the name, address, and phone
number of an FDA contact who was prepared to provide copies of each
proposal, if requested. Therefore, none of these issues raised by this
comment would have affected the ability of the public to comment on the
items listed in the notice of intent.
(Comment 2) One comment opposed the withdrawal of all the proposed
generally recognized as safe (GRAS) actions listed in the notice of
intent unless FDA could provide assurance that the agency would
continue to permit the use of these food ingredients as detailed in the
preamble statements.
(Response) This withdrawal does not affect the regulatory status of
the ingredients listed in these documents. Furthermore, the comment did
not raise any issues not considered by FDA before publication of the
notice of intent to withdraw. Therefore, FDA is withdrawing all the
GRAS proposed rules listed in the notice of intent.
(Comment 3) One comment recommended that the agency withdraw an
ANPRM on hearing aids (58 FR 59695, November 10, 1993) that was not
included in the notice of intent.
[[Page 68833]]
(Response) While the agency agrees that this ANPRM is a good
candidate for withdrawal, because it was not included in the original
notice of intent, we will withdraw or take other action with respect to
this proposal separately, in a future Federal Register notice.
B. Specific Comments
The agency received specific comments on 17 of the documents listed
in the notice of intent. These comments generally supported FDA's
attempt at streamlining the regulations process, and in some cases,
supported the agency's decision to withdraw a certain proposed rule.
However, several of these comments opposed the agency's decision to
withdraw a proposal. The specific comments received, and the agency's
responses are as follows:
1. Cosmetic Products Containing Certain Hormone Ingredients--Docket
No. 91N-0245, September 9, 1993, 58 FR 47611
FDA received 9 comments opposing the withdrawal of this proposed
rule.
(Comment 4) These comments argued that the withdrawal of this
proposed rule would call into question the findings presented in the
proposed rule and possibly change the marketing status of cosmetic
products containing hormone ingredients.
(Response) With regard to the first concern, as stated previously
in this document, this withdrawal neither affirms nor rejects
statements contained in the preamble. With regard to the second
concern, the proposed rule was never finalized, and therefore
withdrawal of the proposed rule does not affect the marketing status of
these products. The agency intends to issue a new proposed rule
regarding these products in the future.
2. Caffeine in Nonalcoholic Carbonated Beverages--Docket No. 82N-
0318, May 20, 1987, 52 FR 18923
3. Shellac and Shellac Wax; Proposed Affirmation of GRAS Status
With Specific Limitations as Direct Human Food Ingredients--Docket No.
89N-0106, July 26, 1989, 54 FR 31055
4. Unmodified Food Starches and Acid-Modified Starches; Proposed
Affirmation of GRAS Status as Direct and Indirect Food Ingredient--
Docket No. 84N-0341, April 1, 1985, 50 FR 12821
5. Caffeine; Deletion of GRAS Status; Proposed Declaration That No
Prior Sanction Exists and Use on an Interim Basis Pending Additional
Study--Docket No. 80N-0418, October 21, 1980, 45 FR 69817
6. Protein Hydrolysates and Enzymatically Hydrolyzed Animal (Milk
Casein) Protein; Proposed GRAS Status--Docket No. 82N-0006, December 8,
1983, 48 FR 54990
7. Cellulose Derivatives; Affirmation of GRAS Status--Docket No.
78N-0144, February 23, 1979, 44 FR 10751
(Comment 5) FDA received five comments on these six GRAS proposed
rules. The majority of the comments opposed the withdrawal of these
proposals.
(Response) None of the comments raised issues not considered by the
agency before publication of the notice of intent to withdraw.
Therefore, FDA is withdrawing all the GRAS proposed rules listed in the
notice of intent. However, this withdrawal does not affect the
regulatory status of the ingredients listed in these documents.
8. Reclassification of Electroconvulsive Therapy--Docket No. 82P-
0316, September 5, 1990, 55 FR 36578
(Comment 6) FDA received one comment supporting the withdrawal of
this proposed rule. However, the comment was concerned that the
information contained in this docket (i.e., reports of adverse
reactions) would be disregarded when the proposed rule was withdrawn.
(Response) The agency is withdrawing this proposed rule, and in the
future, intends to start a new proceeding on this matter. The agency
will retain the data and information contained in this docket and
consider it at that time.
9. Food Labeling; Declaration of Ingredients; Common or Usual Name
Declaration for Protein Hydrolysates and Vegetable Broth in Canned
Tuna; ``and/or'' Labeling for Soft Drinks--Docket No. 90N-361M, January
6, 1993, 58 FR 2950
(Comment 7) FDA received 15 comments supporting and one comment
opposing the withdrawal of this proposed rule. The comment opposing the
withdrawal of this proposed rule stated that the proposed rule
memorialized the development of the agency's policy on ``and/or''
labeling for sweeteners in soft drinks and is the sole source of
reference on these matters. The comment expressed concern that
withdrawal may call into question current and future labeling practices
of the soft drink industry regarding sweeteners in soft drinks.
(Response) The agency disagrees with this comment's implication
that the proposed rule announced a final FDA policy decision on ``and/
or'' labeling for sweeteners in soft drinks. By definition, a proposed
rule only states the agency's tentative conclusions; with limited
exceptions not applicable here, final decisions in the rulemaking
context must be issued in a final rule after public notice and
opportunity for comment (see 5 U.S.C. 553(b) to (c)). Further, the
agency stated in the preamble to the proposed rule (58 FR 2950 at 2953)
that its final decision on whether to revise its regulations to permit
``and/or'' labeling for sweeteners in soft drinks would be based
largely on whether comments in response to the proposed rule included
data demonstrating that it is impracticable to produce the limited
number of versions of a label that would be necessary if ``and/or''
labeling were not permitted. The agency received no such data and
therefore did not have sufficient basis to proceed to a final rule
allowing ``and/or'' labeling for soft drinks. Accordingly, this comment
does not persuade the agency to reconsider the withdrawal of this
proposed rule.
Comments supporting the withdrawal of this proposal asked that the
agency initiate enforcement action against soft drink manufacturers
that use ``and/or'' labeling. The agency acknowledges that it has not
pursued any enforcement action against soft drink manufacturers who are
using ``and/or'' labeling because of the pending rulemaking. The agency
is considering its position on the use of ``and/or'' labeling.
10. Yogurt Products; Frozen Yogurt, Frozen Lowfat Yogurt; and
Frozen Nonfat Yogurt; Petitions to Establish Standards of Identity and
to Amend Existing Standards--Docket Nos. 89P-0208 and 89P-0444, May 31,
1991, 56 FR 24760
(Comment 8) The agency received one comment supporting the
withdrawal of this proposed rule. The comment agreed that there is no
need to complete this rulemaking since the agency issued an ANPRM (68
FR 39873) in 2003 to address this issue.
(Response) The agency agrees. Therefore, FDA is withdrawing this
proposed rule.
11. Canned Pineapple; Proposal to Amend Standards of Identity and
Quality--Docket No. 88P-0224, March 24, 1989, 54 FR 12237
FDA received two comments opposing the withdrawal of this proposed
rule.
(Comment 9) One comment requested that, if FDA withdraws the
proposed rule, FDA allow marketing for canned pineapple as a
nonstandardized product.
(Response) FDA is denying this request because a product that
purports to be or is represented as a food for which a standard of
identity has been prescribed (e.g., canned pineapple) that does not
comply with the provisions of that standard is misbranded under
[[Page 68834]]
section 403(g) of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 343(g)). FDA notes, however, that regulations in Sec.
130.17 (21 CFR 130.17) provide that manufacturers may market foods that
deviate from established standards of identity if they receive
temporary marketing permits from FDA.
(Comment 10) The second comment stated that there are temporary
marketing permits issued under this proposal that would not be valid if
the proposal is withdrawn.
(Response) The comment is incorrect. There are no active temporary
marketing permits to market test a ``whole'' style of canned pineapple
that are the basis of this proposed rule. There were two temporary
market permits that were issued in 1988 to Dole Packaged Foods Co. (53
FR 16471, May 9, 1988) and to Del Monte Corp. (53 FR 23602, June 22,
1988), which expired after 15 months. The agency is withdrawing this
proposed rule.
12. Current Good Manufacturing Practices; Proposed Exemption From
Active Ingredient Identity and Strength Testing for Homoeopathic Drug
Products--Docket No. 79P-0265, April 1, 1983, 48 FR 14003
(Comment 11) The agency received one comment opposing the
withdrawal of this proposed rule which would have exempted homeopathic
drugs from the current good manufacturing practice (CGMP) requirements
that drug products be tested for identity and strength of each active
ingredient prior to release for distribution. The comment expressed
concerns about possible changes in our enforcement policy towards final
release testing of homeopathic drugs.
(Response) There may be instances where testing of a homeopathic
product for identity and strength of the active ingredients prior to
release for distribution would be appropriate and consistent with
protection of the public health. For example, in instances where a
product includes an active ingredient that at certain levels could be
toxic or otherwise pose a public health concern, finished product
testing may be appropriate because the testing could identify a
significant manufacturing or labeling error. Since requiring this
testing when necessary to protect the public health is consistent with
FDA's mandate, we are withdrawing the proposed rule.
13. Pineapple Juice; Proposal to Amend U.S. Standards of Identity
and Quality--Docket No. 86P-0338, May 21, 1987, 52 FR 19169
FDA received two comments opposing the withdrawal of this proposed
rule.
(Comment 12) One comment requested that if FDA withdraws the
proposed rule, FDA allow marketing for pineapple juice as a
nonstandardized product.
(Response) FDA is denying this request because a product that
purports to be or is represented as a food for which a standard of
identity has been prescribed (e.g., pineapple juice) that does not
comply with the provisions of that standard is misbranded under section
403(g) of the act. FDA notes, however, that regulations in Sec. 130.17
provide that manufacturers may market foods that deviate from
established standards of identity if they receive temporary marketing
permits from FDA.
(Comment 13) The second comment stated that this proposed rule
allowed the addition of pineapple juice from concentrate to pineapple
juice to increase the brix level. Because the proposed rule addressed
the use of pineapple juice from concentrate, the comment asks the
agency either to complete this rulemaking or to publish a notice of
policy that 21 CFR 102.33 (which applies to nonstandardized juices)
would apply to pineapple juice.
(Response) The comment is incorrect in stating that the proposed
rule allowed the addition of pineapple juice from concentrate to
increase the brix level of pineapple juice in Sec. 146.185 (21 CFR
146.185). The proposed rule only proposed to amend the standard of
identity to allow this change. This amendment would not be effective
until the rule was finalized. Thus, currently, the standard of identity
for pineapple juice in Sec. 146.185 does not permit the use of
pineapple juice from concentrate to increase the brix level. A
manufacturer who wishes to market pineapple juice with added pineapple
juice from concentrate to increase the brix level may apply for a
temporary marketing permit to do so. The agency is withdrawing this
proposed rule.
14. Regulation of Medical Foods--Docket No. 96N-0364, November 29,
1996, 61 FR 60661
(Comment 14) The agency received one comment opposing the
withdrawal of this ANPRM. The comment stated that manufacturers are
marketing therapeutic products directly to consumers without prior FDA
approval of health claims or FDA review of the suitability of the
ingredients for the intended population. The comment stated that
current FDA policies in this area create a loophole for manufacturers
to make unauthorized health claims and use ingredients that may not be
GRAS.
(Response) This comment does not persuade FDA that the ANPRM should
not be withdrawn. Because of competing priorities that have tied up
FDA's limited resources, the agency has been unable to consider, in a
timely manner, the issues raised by comments on the ANPRM, and does not
foresee having sufficient resources in the near term to do so.
Therefore, the agency is withdrawing this ANPRM. However, FDA believes
that the basic principles described in the ANPRM provide an appropriate
framework for understanding the regulatory paradigm governing medical
foods. Therefore, FDA advises that it will continue to refer to the
basic principles described in the ANPRM and in FDA's Medical Foods
Compliance Program (CP 7321.002) when evaluating medical foods. With
regard to the specific points made in the comment regarding regulation
of medical foods, the comment is correct that the act exempts medical
foods from the nutrition labeling, health claim and nutrient content
claim requirements that are applicable to most other foods. However,
all statements on food labels (including medical foods) must be
truthful and not misleading (see section 403(a)(1) of the act). FDA
advises that medical foods with false or misleading labeling are
subject to enforcement action. The agency also advises that withdrawal
of this ANPRM does not change the requirement that all ingredients used
in medical foods must be approved food additives, GRAS, or otherwise
exempt from the food additive definition. Medical foods that do not
comply with this requirement are subject to enforcement action.
15. Food Labeling: Nutrient Content Claims Pertaining to the
Available Fat Content of Food--Docket Nos. 96N-0421 and 94P-0453/CP1,
December 20, 1996, 61 FR 67243
(Comment 15) FDA received one comment opposing the withdrawal of
this proposed rule. The comment states that misleading claims are being
made by producers of products that contain nondigestible fat, including
olestra, and that the total amount of fat in a product--regardless of
whether it is digestible or nondigestible--should be declared to avoid
consumer deception. The proposed rule responds in part to a citizen
petition requesting use of digestibility coefficients in determining
the quantity of fat declared in the label.
(Response) Currently, FDA regulations require that nutrition
labeling and claims reflect the total amount of fat, which is defined
as total lipid fatty acids and expressed as triglycerides Sec.
101.9(c)(2) (21 CFR 101.9(c)(2)). The only exceptions to this general
requirement are provided in the following: (1) The voluntary nutrition
[[Page 68835]]
labeling final rule for raw fruit, vegetables, and fish (61 FR 42742,
August 16, 1996) with respect to total fat in orange roughy fish and
(2) the final rule for olestra (61 FR 3118, January 30, 1996) (61 FR
67243 at 67246). In the final rule for olestra, FDA specified that
olestra need not be considered as a source of fat or calories for
purposes of nutrition labeling or nutrient content claims (21 CFR
172.867(e)(5)).
By withdrawing this proposed rule, FDA will not be authorizing the
use of digestibility coefficients, so that the total amount of fat in a
product must be declared on the label whether it is digestible or
nondigestible as provided in Sec. 101.9(c)(2). However, withdrawing
this proposed rule will have no effect on the nutrition labeling of
products containing olestra or how the agency calculates the fat
content of orange roughy for the purpose of voluntary nutrition
labeling of that raw fish. Due to the agency's limited resources and
other higher priority matters, the agency is withdrawing this proposed
rule.
16. Food Labeling; Nutrient Content Claims and Health Claims;
Special Requirements--Docket No. 95N-0103, February 2, 1996, 61 FR 3885
(Comment 16) The agency received one comment opposing the
withdrawal of this proposed rule. The comment states that FDA access to
records needed to evaluate the validity of nutrient content claims and
health claims is essential to prevent consumer deception and ensure
fair competition.
(Response) FDA continues to believe that, for health and nutrient
content claims that pose particular enforcement difficulties, it would
be valuable for the agency to have access to information that the
manufacturer relied on in determining that the food meets the
requirements of the claims. As the agency stated in the proposed rule
(61 FR 3385 at 3889), the claims that are likely to present enforcement
difficulties are those based on new food technology or a new use of
food technology, those based on the results of novel or non-
standardized testing procedures, and those which the agency cannot
evaluate without information because the information is available only
to the manufacturer. However, other higher priority matters require the
agency's resources at this time, and therefore, the agency is
withdrawing this proposed rule.
17. Food Labeling; Declaration of Free Glutamate in Food--Docket
No. 96N-0244, September 12, 1996, 61 FR 48102
(Comment 17) FDA received two comments supporting the withdrawal of
this ANPRM.
(Response) Thus, the agency is withdrawing this ANPRM.
For the reasons set forth previously, and under the act, the agency
announces the withdrawal of the following documents, published in the
Federal Register on the dates indicated in table 1:
Table 1.
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FR Publication
Title Docket No. Date and Cite
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Radioactive Drugs, Including 75N-0069 July 25. 1975, 40
Biological Products FR 31314
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Conditions for Use of Methadone; 75N-0125 April 29, 1976, 41
Notice of Proposed Rulemaking FR 17922
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Pasteurized Milk Ordinance and 75N-0243 May 5, 1975, 40 FR
Interstate Milk Shippers 19513
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Oral Contraceptive Drug Products; 75N-0304 December 7, 1976,
Physician and Patient Labeling 41 FR 53633
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Penicillin Streptomycin Powder; 75N-0374 July 9, 1976, 41
Penicillin-Dihydrostreptomycin FR 28313
Powder; Proposed Revocation of
Certification Provision
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Conditions for Use of Methadone; 76N-0098 April 29, 1976, 41
Physiologic Dependence, Staffing, FR 17926
and Urine Testing Requirements
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Sorbic Acid and Its Salts; Proposed 77G-0379\1\ March 10, 1978, 43
Affirmation and Deletion of GRAS FR 9823
Status
------------------------------------------------------------------------
Butylated Hydroxytoluene; Use 77N-0003\1\ May 31, 1977, 42
Restrictions FR 27603
------------------------------------------------------------------------
Color Additives; Proposed Use of 77N-0009 and June 6, 1985, 50
Abbreviations for Labeling Foods, 78P-0164 FR 23815
Drugs, Cosmetics, and Medical
Devices
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Brown and Yellow Mustard and Their 77N--0033\1\ August 26, 1977,
Derivatives; Proposed Affirmation of 42 FR 43092
GRAS Status as Direct Human Food
Ingredients
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Acrylonitrile Copolymers Intended for 77N--0078 March 11, 1977, 42
Use in Contact With Food; Proposed FR 13562
Rulemaking
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Gelatin; Affirmation of GRAS Status 77N-0232\1\ November 11, 1977,
as a Direct and Indirect Human Food 42 FR 58763 and
Ingredient May 12, 1993, 58
FR 27959
(tentative final
rule)
------------------------------------------------------------------------
New Animal Drugs for Use in Animal 77N-0318 January 20, 1978,
Feeds; Animal Feeds Containing 43 FR 3032
Penicillin and Tetracycline
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Ethylene Oxide, Ethylene 77N-0424\1\ June 23. 1978, 43
Chlorohydrin, and Ethylene Glycol; FR 27474
Proposed Maximum Residue Limits and
Maximum Levels of Exposure
------------------------------------------------------------------------
Label Designation of Ingredients in 77P-0146 July 19, 1984, 49
Cheese and Cheese Products FR 29242
------------------------------------------------------------------------
Food Chemicals Codex Monographs; 78N-0072 April 18, 1978, 43
Opportunity for Public Comment on FR 16413
Revisions
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[[Page 68836]]
Cellulose Derivatives; Affirmation of 78N-0144\1\ February 23, 1979,
GRAS Status 44 FR 10751
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Tocopherols and Derivatives; Proposed 78N-0213\1\ October 27, 1978,
Affirmation of GRAS Status for 43 FR 50193
Certain Tocopherols and Removal of
Certain Others From GRAS Status as
Direct Human Food Ingredients
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Chlortetracycline-Sulfamethazine 78N-0247 September 22,
Tablets; Proposed Rulemaking 1978, 43 FR 43036
------------------------------------------------------------------------
Phosphates; Proposed Affirmation of 78N-0272 December 18, 1979,
and Deletion From GRAS Status as 44 FR 74845
Direct and Human Food Ingredients
------------------------------------------------------------------------
Biotin; Proposed Affirmation of GRAS 78N-0308\1\ January 14, 1983,
Status 48 FR 1739
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Lard and Lard Oil; Proposed 78N-0336\1\ May 18, 1979, 44
Affirmation of GRAS Status as FR 29102
Indirect Human Food Ingredients
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Glycerin; Affirmation of GRAS Status 78N-0348\1\ February 8, 1983,
as a Direct Human Food Ingredient 48 FR 5758
------------------------------------------------------------------------
Medical Devices; Classification of 78N-1074 November 28, 1978,
Sponges for Internal Use 43 FR 55697
------------------------------------------------------------------------
Medical Devices; Classification of 78N-1183 August 28, 1979,
Powered Myoelectric Biofeedback 44 FR 50464
Equipment
------------------------------------------------------------------------
Porcine Burn Dressing 78N-2670 January 19 1982,
47 FR 2828
------------------------------------------------------------------------
Food Ingredient Labeling; Emulsifiers 78P-0052 April 17, 1985, 50
and Stabilizers; Exemptions FR 15177
------------------------------------------------------------------------
Sodium Dithionite and Zinc 79N-0095\1\ January 25, 1980,
Dithionite; Proposed Affirmation of 45 FR 6117 and
GRAS Status September 17,
1982, 47 FR 41137
(tentative final
rule)
------------------------------------------------------------------------
Current Good Manufacturing Practice 79P-0265 April 1, 1983, 48
in Manufacture Processing, Packing, FR 14003
or Holding; Proposed Exemption From
Active Ingredient Identity and
Strength Testing for Homeopathic
Drug Products
------------------------------------------------------------------------
Hydrochloric Acid; Proposed 80N-0148\1\ April 26, 1984, 49
Affirmation of GRAS Status as a FR 17966
Direct Human Food Ingredient
------------------------------------------------------------------------
Cheeses and Related Cheese Products; 80N-0373 April 23, 1984, 49
General Standard of Identity for FR 17018
``Certain Other Cheeses''
------------------------------------------------------------------------
Caffeine; Deletion of GRAS Status, 80N-0418\1\ October 21, 1980,
Proposed Declaration That No Prior 45 FR 69817
Sanction Exists, and Use on an
Interim Basis Pending Additional
Study
------------------------------------------------------------------------
Policy for Recognizing Carcinogenic 81N-0281 April 2, 1982, 47
Chemicals in Food and Color FR 14464
Additives; Advance Notice of
Proposed Rulemaking
------------------------------------------------------------------------
Magnesium Gluconate, Potassium 81N-0382 October 29, 1982,
Gluconate, Sodium Gluconate, Zinc 47 FR 49028
Gluconate, and Gluconic Acid:
Proposed GRAS Status as Direct and
Indirect Human Food Ingredients
------------------------------------------------------------------------
Protein Hydrolysates and 82N-0006\1\ December 8, 1983,
Enzymatically Hydrolyzed Animal 48 FR 54990
(Milk Casein) Protein; Proposed GRAS
Status
------------------------------------------------------------------------
Zinc Salts: Proposed Affirmation of 82N-0167\1\ October 26, 1982,
GRAS Status 47 FR 47441
------------------------------------------------------------------------
Regenerated Collagen; Proposed GRAS 82N-0219\1\ April 26,1983, 48
Status as a Direct Human Food FR 18833
Ingredient
------------------------------------------------------------------------
Ascorbic Acid and Its Sodium and 82N-0246\1\ January 14, 1983,
Calcium Salts, Erythorbic Acid and 48 FR 1735
Its Sodium Salt, and Ascorbyl
Palmitate; Proposed Affirmation of
GRAS Status and Removal of Calcium
Ascorbate From the List of GRAS
Ingredients
------------------------------------------------------------------------
Caffeine in Nonalcoholic Carbonated 82N-0318 May 20, 1987, 52
Beverages FR 18923
------------------------------------------------------------------------
Common or Usual Names for 82N-0389 June 1, 1984, 49
Nonstandardized Foods; Diluted Fruit FR 22831
or Vegetable Juice Beverages
------------------------------------------------------------------------
Neurological Devices, Proposed Rule 82P-0316 September 5, 1990,
to Reclassify the Electroconvulsive 55 FR 36578
Therapy Device Intended for Use in
Treating Severe Depression
------------------------------------------------------------------------
New Drug and Antibiotic Application 84N-0101 August 6, 1985, 50
Review; Proposed User Charge FR 31726
------------------------------------------------------------------------
[[Page 68837]]
Proposed Uses of Vinyl Chloride 84N-0334 February 3, 1986,
Polymers 51 FR 4177
------------------------------------------------------------------------
Unmodified Food Starches and Acid 84N-0341\1\ April 1, 1985, 50
Modifled Starches--Proposed FR 12821
Affirmation of GRAS Status as Direct
and Indirect Human Food Ingredients
------------------------------------------------------------------------
Use of Acrylonitrile Copolymers 85N-0145 March 8, 1990, 55
FR 8476
------------------------------------------------------------------------
Hematology and Pathology Devices; 85N-0241 February 19, 1988,
Premarket Approval of the Automated 53 FR 5108
Blood Cell Separator Intended for
Routine Collection of Blood and
Blood Components
------------------------------------------------------------------------
New Drugs for Human Use: Proposed 86N-0077 June 4, 1986, 51
Clarification of Requirements for FR 20310
Application Supplements
------------------------------------------------------------------------
Quality Standards for Foods With No 86N-0445 September 16,
Identity Standards; Bottled Water 1988, 53 FR 36063
------------------------------------------------------------------------
Pineapple Juice; Proposal to Amend 86P-0338 May 21, 1987, 52
U.S. Standards of Identity and FR 19169
Quality
------------------------------------------------------------------------
New Animal Drug Regulations 88N-0058 December 17, 1991,
56 FR 65544
------------------------------------------------------------------------
Current Good Manufacturing Practice 88N-0413 June 6, 1989, 54
for Blood and Blood Components; FR 24296
Proficiency Testing Requirements
------------------------------------------------------------------------
Canned Pineapple; Proposal To Amend 88P-0224 March 24, 1989, 54
Standards of Identity and Quality FR 12237
------------------------------------------------------------------------
Shellac and Shellac Wax; Proposed 89N-0106 July 26, 1989, 54
Affirmation of GRAS Status With FR 31055
Specific Limitations as Direct Human
Food Ingredients
------------------------------------------------------------------------
Erythromycin Capsules; Proposed 89N-0378\1\ October 26, 1989,
Amendment of Dissolution Standard of 54 FR 43592
Erythromycin Capsules
------------------------------------------------------------------------
Yogurt Products; Frozen Yogurt, 89P-0208 and May 31, 1991, 56
Frozen Lowfat Yogurt, and Frozen 89P-0444 FR 24760
Nonfat Yogurt; Petitions To
Establish Standards of Identity and
To Amend the Existing Standards
------------------------------------------------------------------------
Exemption From Preemption of State 89P-0314 October 30, 1990,
and Local Hearing Aid Requirements; 55 FR 45615
Vermont
------------------------------------------------------------------------
Food Labeling; Declaration of 90N-0361M January 6, 1993,
Ingredients, Common or Usual Name 58 FR 2950
Declaration for Protein Hydrolysates
and Vegetable Broth in Canned Tuna;
``and/or'' Labeling for Soft Drinks
------------------------------------------------------------------------
Use of Aseptic Processing and 91N-0074 October 11, 1991,
Terminal Sterilization in the 56 FR 51354
Preparation of Sterile
Pharmaceuticals for Human and
Veterinary Use
------------------------------------------------------------------------
Cosmetic Products Containing Certain 91N-0245 September 9, 1993,
Hormone Ingredients; Notice of 58 FR 47611
Proposed Rulemaking
------------------------------------------------------------------------
Substances in Food-Contact Articles 74-8424 April 12, 1974, 39
in the Household, Food Service FR 13285
Establishments, and Food Dispensing
Equipment; Food Additive Status
------------------------------------------------------------------------
Drug Listing Compliance Verification 92N-0291 September 2, 1993,
Reports 58 FR 46587
------------------------------------------------------------------------
Food Labeling: Metric Labeling 92N-0406 May 21, 1993, 58
Requirements FR 29716
------------------------------------------------------------------------
Food Labeling: Net Quantity of 92P-0441 March 4, 1997, 62
Contents; Compliance FR 9826
------------------------------------------------------------------------
Cardiovascular Devices; Effective 93M-0150 July 6, 1993, 58
Date of Requirement for PMA of FR 36290
Nonroller-Type
Cardiopulmonary Bypass Blood Pump
------------------------------------------------------------------------
Laser Products; Proposed Amendment to 93N-0044 March 24, 1999, 64
Performance Standards FR 14180
------------------------------------------------------------------------
Quality Standards for Foods With No 93N-0200 October 6, 1993,
Identity Standards; Bottled Water 58 FR 52042
------------------------------------------------------------------------
Metric Labeling; Quantity of Contents 92N-0406 and December 21, 1993,
Labeling Requirement for Foods, 93N-0226 58 FR 67444
Human and Animal Drugs, Animal
Foods, Cosmetics, and Medical
Devices
------------------------------------------------------------------------
Lead in Food and Color Additives and 93N-0348 February 4, 1994,
GRAS Ingredients; Request for Data 59 FR 5363
------------------------------------------------------------------------
Substances Prohibited From Use in 93N-0467 August 29, 1994,
Animal Food or Feed; Specified Offal 59 FR 44584
From Adult Sheep and Goats
Prohibited in Ruminant Feed; Scrapie
------------------------------------------------------------------------
[[Page 68838]]
Dental Devices; Effective Date of 95N-0034 July 11, 1995, 60
Requirement for Premarket Approval FR 35713
of Over-the-Counter (OTC) Denture
Cushions or Pads and OTC Denture
Repair Kits
------------------------------------------------------------------------
Food Labeling; Nutrient Content 95N-0103 February 2, 1996,
Claims and Health Claims; Special 61 FR 3885
Requirements
------------------------------------------------------------------------
Maltodextrin; Food Chemicals Codex 95N-0189 September 21,
Specifications 1995, 60 FR 48939
------------------------------------------------------------------------
Beverages: Bottled Water 95N-0203 November 13, 1995,
60 FR 57132
------------------------------------------------------------------------
Dental Devices; Effective Date of 95N-0298 November 29, 1995,
Requirement for Premarket Approval 60 FR 61232
of Partially Fabricated Denture Kits
------------------------------------------------------------------------
Lowfat and Skim Milk Products, Lowfat 95P-0250 November 9, 1995,
and Nonfat Yogurt Products, Lowfat 60 FR 56541
Cottage Cheese: Proposed Revocation
of Standards of Identity; Food
Labeling, Nutrient Content Claims
for Fat, Fatty Acids and Cholesterol
Content of Food
------------------------------------------------------------------------
Food Standards; Reinvention of 96N-0149 June 12, 1996, 61
Regulations Needing Revisions, FR 29701
Request for Comments on Certain
Existing Regulations
------------------------------------------------------------------------
Reinvention of Certain Food Additive 96N-0177 June 12, 1996, 61
Regulations FR 29711
------------------------------------------------------------------------
Food Labeling; Declaration of Free 96N-0244 September 12,
Glutamate In Food 1996, 61 FR 48102
------------------------------------------------------------------------
Regulation of Medical Foods 96N-0364 November 29, 1996,
61 FR 60661
------------------------------------------------------------------------
Food Labeling: Nutrient Content 96N-0421 and December 20, 1996,
Claims Pertaining to the Available 94P-0453/CP1 61 FR 67243
Fat Content of Food
------------------------------------------------------------------------
Food Labeling; Serving Sizes; 96P-0023 and January 8, 1998,
Reference Amounts for Candies 96P-0179 63 FR 1078
------------------------------------------------------------------------
\1\Denotes documents that were included in the December 1991 withdrawal
notice, but were not withdrawn at that time.
Dated: August 30, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-26234 Filed 11-24-04; 8:45 am]
BILLING CODE 4160-01-S