Document ID: FDA-2011-D-0674-0001
Agency: fda
Document Type: Notice
Title: Draft Guidance for Industry;Food and Drug Administration Records Access Authority under Federal Food, Drug, and Cosmetic Act; Availability
Posted Date: 2012-02-23T05:00Z

[Federal Register Volume 77, Number 36 (Thursday, February 23, 2012)]
[Notices]
[Pages 10753-10754]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-4166]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

Draft Guidance for Industry: Food and Drug Administration Records 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.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a draft guidance for industry entitled ``FDA Records 
Access Authority Under Sections 414 and 704 of the Federal Food, Drug, 
& Cosmetic Act.'' This draft guidance provides updated information 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: 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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 23, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Outreach and Information Center (HFS-009), Center for 
Food Safety and Applied Nutrition (HFS-317), Food and Drug 
Administration, 5100 Paint Branch Pkwy., College Park, MD 20740. Send 
one self-addressed adhesive label to assist that office in processing 
your request. 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access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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 on the guidance 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, Food and Drug Administration, 5100 
Paint Branch Pkwy., College Park, MD 20740, 240-402-1611.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``FDA Records Access Authority Under Sections 414 and 704 of 
the Federal Food, Drug, & Cosmetic Act.'' The draft guidance is 
intended for persons who manufacture, process, pack, hold, or import 
human or animal foods intended for distribution to consumers, 
institutions, or food processors. This draft guidance provides updated 
information pertaining to FDA's authority to access and copy records 
relating to food under sections 414(a) and 704(a)(1)(B) of the Federal 
Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 350c(a) and 21 
U.S.C. 374(a)(1)(B), respectively), as amended by section 101 of the 
FDA Food Safety and Modernization Act (FSMA) (Pub. L. 111-353) of 
January 4, 2011.
    Section 414 was originally added to the FD&C Act by the Public 
Health Security and Bioterrorism Preparedness and Response Act of 2002 
(Pub. L. 107-188). FSMA, signed into law on January 4, 2011, expanded 
FDA's access to records under section 414. Prior to the passage of 
FSMA, section 414(a) of the FD&C Act provided the Secretary (by 
delegation FDA) with authority to access records relating to food that 
was reasonably believed to be adulterated and to present a threat of 
serious adverse health consequences or death to humans or animals. Now 
under section 414(a)(1), as amended by FSMA, FDA's records access 
extends beyond records relating to the specific suspect article of food 
to records relating to any other article of food that FDA reasonably 
believes is likely to be affected in a similar manner. In addition, 
under section 414(a)(2), FDA can access records if it believes that 
there is a reasonable probability that the use of or exposure to an 
article of food, and any other article of food that FDA reasonably 
believes is likely to be affected in a similar manner, will cause 
serious adverse health consequences or death to humans or animals. 
Furthermore, FSMA revised section 704(a)(1)(B), which pertains to 
factory inspections, to refer to the amended version of section 414(a).
    This updated draft guidance is intended to provide individuals in 
the human and animal food industries with an overview of FDA's 
authority to access and copy records. It provides practical information 
by answering common questions that cover a range of topics, including 
when FDA has the authority to access and copy records, the 
circumstances under which FDA is likely to request records, the types 
of records FDA may request and copy, and the consequences of refusing 
to provide records access. The Agency has adopted good guidance 
practices (GGPs) that set forth the Agency's policies and procedures 
for the development, issuance, and use of guidance documents (21 CFR 
10.115). This draft guidance is being issued as level 1 guidance 
consistent with GGPs.
    The draft guidance, when finalized, will represent the Agency's 
current thinking on its authority to access and copy records. It does 
not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternate 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 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 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.

[[Page 10754]]

III. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. 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.

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. 
Always access an FDA guidance document by using the Web sites listed 
previously to find the most current version of the guidance.

    Dated: February 17, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4166 Filed 2-22-12; 8:45 am]
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