[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)]
[Notices]
[Pages 15217-15218]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-06498]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1288]
Electronic Submission of Lot Distribution Reports; Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a document entitled ``Electronic Submission of Lot
Distribution Reports; Guidance for Industry.'' The guidance document
provides information and recommendations pertaining to the electronic
submission of lot distribution reports for applicants with approved
biologics license applications (BLAs). FDA recently published in the
Federal Register a final rule requiring that, among other things, lot
distribution reports be submitted to FDA in an electronic format that
the Agency can process, review, and archive. The guidance announced in
this notice finalizes the draft guidance entitled ``Guidance for
Industry: Electronic Submission of Lot Distribution Reports'' dated
August 2014, and is intended to help licensed manufacturers of products
distributed under an approved BLA (henceforth referred to as
applicants) comply with the final rule.
DATES: Submit either electronic or written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Communication, Outreach and Development, Center for
Biologics Evaluation and Research (CBER), Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-
0002 or Division of Drug Information, Center for Drug Evaluation and
Research (CDER), Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist the office in processing your
requests. The guidance may also be obtained by mail by calling CBER at
1-800-835-4709 or 240-402-7800. See the SUPPLEMENTARY INFORMATION
section for electronic access to the guidance document.
Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Lori J. Churchyard, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002,
240-402-7911; or Jared Lantzy, Center for Drug Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm.
1116, Silver Spring, MD 20993, email: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a document entitled
``Electronic Submission of Lot Distribution Reports; Guidance for
Industry.'' The guidance provides information and recommendations
pertaining to the electronic submission of lot distribution reports.
The guidance provides information on how to electronically submit lot
distribution reports for biological products under approved BLAs for
which CBER or CDER has regulatory responsibility. The guidance does not
apply to any other biological product.
FDA published in the Federal Register of June 10, 2014 (79 FR
33072), a final rule requiring electronic submission of certain
postmarketing submissions. Among other things, under this rule
applicants are required to submit biological lot distribution reports
to FDA in an electronic format that the Agency can process, review, and
archive. The guidance is intended to help applicants subject to lot
distribution reporting comply with the final rule. Along with other
information, the guidance provides updated information about the
following: (1) Structured Product Labeling standard and vocabulary for
electronic submission of lot distribution reporting; (2) additional
resources such as implementation guide, validation procedures and links
with further information; and (3) procedures for requesting temporary
waivers from the electronic submission requirement.
In the Federal Register of August 29, 2014 (79 FR 51576), FDA
announced the availability of the draft guidance entitled '' Guidance
for Industry: Electronic Submission of Lot Distribution Reports'' dated
August 2014. FDA published a correction notice to correct the docket
number in the Federal Register of September 16, 2014 (79 FR 55497). FDA
received a few comments on the draft guidance and those comments were
considered as the guidance was finalized. FDA is finalizing the draft
guidance with only editorial changes. The guidance announced in this
notice finalizes the draft guidance dated August 2014.
The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 600.81 and 600.90 have been
approved under 0910-0308.
III. Comments
Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or http://www.regulations.gov.
[[Page 15218]]
Dated: March 17, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-06498 Filed 3-20-15; 8:45 am]
BILLING CODE 4164-01-P