
[Federal Register Volume 80, Number 55 (Monday, March 23, 2015)]
[Notices]
[Pages 15217-15218]
From the Federal Register Online via the Government Printing 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this notice finalizes the draft guidance entitled ``Guidance for 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: esub@fda.hhs.gov.

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


