
[Federal Register Volume 79, Number 168 (Friday, August 29, 2014)]
[Notices]
[Pages 51576-51577]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-20635]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-S-0009]


Draft Guidance for Industry: Electronic Submission of Lot 
Distribution Reports; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft document entitled ``Guidance for Industry: 
Electronic Submission of Lot Distribution Reports'' dated August 2014. 
The draft guidance document provides information and recommendations 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 
draft guidance, when finalized, is intended to help licensed 
manufacturers of products distributed under approved BLAs (henceforth 
referred to as applicants) comply with the final rule.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by November 28, 2014.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Office of Communication, Outreach and Development, 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, 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 The draft guidance may also be obtained by mail by 
calling CBER at 1-800-835-4709 or 240-402-7800 or CDER at 301-796-3400. 
See the SUPPLEMENTARY INFORMATION section for electronic access to the 
draft guidance document.
    Submit electronic comments on the draft 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 
(CDER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
22, Rm. 1116, Silver Spring, MD 20993-0002, email: esub@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft document entitled 
``Guidance for Industry: Electronic Submission of Lot Distribution 
Reports'' dated August 2014. The draft guidance provides information 
and recommendations pertaining to the electronic submission of lot 
distribution reports. The draft 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. When finalized, this guidance will not apply to any 
other biological product.
    FDA recently 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 draft guidance, when finalized, is intended to help 
applicants subject to lot distribution reporting comply with the final 
rule. Along with other information, the draft 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.
    The draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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 draft 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

[[Page 51577]]

600.90 have been approved under OMB control number 0910-0308.

III. Comments

    The draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. 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 draft 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.

    Dated: August 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-20635 Filed 8-28-14; 8:45 am]
BILLING CODE 4164-01-P


