[Federal Register Volume 79, Number 65 (Friday, April 4, 2014)]
[Proposed Rules]
[Pages 18866-18867]
From the Federal Register Online via the Government Publishing 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