Document ID: FDA-2011-D-0674-0043
Agency: fda
Document Type: Rule
Title: Guidance for Industry: Food and Drug Administration Records Access
Authority Under the Federal Food, Drug, and Cosmetic Act; Availability
Posted Date: 2014-04-04T04:00Z

[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Proposed Rules]
[Pages 18866-18867]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-07551]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2011-D-0674]

Guidance for Industry: Food and Drug Administration Records 
Access Authority Under the Federal Food, Drug, and Cosmetic Act; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a guidance for industry entitled ``FDA Records Access 
Authority Under Sections 414 and 704 of the Federal Food, Drug, and 
Cosmetic Act.'' The guidance provides updated information pertaining to 
FDA's authority to access and copy records relating to food. It is a 
revision of FDA's November 2005 guidance entitled ``Guidance for 
Industry and FDA Staff: Guidance for Records Access Authority Provided 
in Title III, Subtitle A, of the Public Health Security and 
Bioterrorism Preparedness and Response Act of 2002; Final Guidance.''

DATES: Submit either electronic or written comments on FDA guidances at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance to 
the Outreach and Information Center, Center for Food Safety and Applied 
Nutrition (HFS-317), Food and Drug Administration, 5100 Paint Branch 
Pkwy., College Park, MD 20740. Send two self-addressed adhesive labels 
to assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance.
    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: William A. Correll, Jr., Center for 
Food Safety and Applied Nutrition (HFS-607), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 240-
402-1611.

SUPPLEMENTARY INFORMATION: 

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``FDA Records Access Authority Under Sections 414 and 704 of 
the Federal Food, Drug, and Cosmetic Act.'' This guidance is being 
issued consistent with our good guidance practices regulation (21 CFR 
10.115). The guidance represents our 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.
    In the Federal Register of February 23, 2012 (77 FR 10753), we made 
available a draft guidance for industry entitled ``FDA Records Access 
Authority Under Sections 414 and 704 of the Federal Food, Drug, and 
Cosmetic Act'' and gave interested parties an opportunity to submit 
comments by May 23, 2012, for us to consider before beginning work on 
the final version of the guidance. We received several comments on the 
draft guidance. Other than providing further information on where to 
find guidance on the procedural steps for FDA staff to follow when 
accessing records under sections 414 and 704 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 350c and 21 U.S.C. 374, respectively), we 
are issuing the guidance with a few minor changes. The guidance 
announced in this notice finalizes the draft guidance dated February 
2012.

II. Paperwork Reduction Act of 1995

    This guidance refers to information collection provisions 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). We

[[Page 18867]]

conclude that these information collection provisions are exempt from 
OMB review under 44 U.S.C. 3518(c)(1)(B)(ii) and 5 CFR 1320.4(a)(2) as 
collections of information obtained during the conduct of a civil 
action to which the United States or any official or Agency thereof is 
a party, or during the conduct of an administrative action, 
investigation, or audit involving an Agency against specific 
individuals or entities. The regulations in 5 CFR 1320.3(c) provide 
that the exception in 5 CFR 1320.4(a)(2) applies during the entire 
course of the investigation, audit or action, but only after a case 
file or equivalent is opened with respect to a particular party. Such a 
case file would be opened as part of the request to access records.

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/FoodGuidances or http://www.regulations.gov. 
Use the FDA Web site listed in the previous sentence to find the most 
current version of the guidance.

    Dated: April 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-07551 Filed 4-3-14; 8:45 am]
BILLING CODE 4160-01-P