Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal Food, Drug, and Cosmetic Act; Availability, 18866-18867 [2014-07551]
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Federal Register / Vol. 79, No. 65 / Friday, April 4, 2014 / Proposed Rules
except for the word ‘‘ONLY,’’ which is
in 26 point font. The word ‘‘ONLY’’ is
underlined with a 2 point (or thick)
underline. The second line is in 16
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(f) * * *
By direction of the Commission.
Donald S. Clark,
Secretary.
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 https://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:
(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available a draft guidance for industry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comments on the draft guidance.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.
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
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
[FR Doc. 2014–07423 Filed 4–3–14; 8:45 am]
BILLING CODE 6750–01–P
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.
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
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SUMMARY:
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(ii) The band should measure 1 inch
(2.54 cm) deep. The percentage
disclosure and the word ‘‘ETHANOL’’
are in 24 point font. The type below the
black band is centered vertically and
horizontally. The first line is the text:
‘‘USE ONLY IN.’’ It is in 16 point font,
Federal Register / Vol. 79, No. 65 / Friday, April 4, 2014 / Proposed Rules
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 https://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 https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the guidance at either
https://www.fda.gov/FoodGuidances or
https://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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
emcdonald on DSK67QTVN1PROD with PROPOSALS
21 CFR Part 1
[Docket No. FDA–2013–N–1421]
Guidance for Industry on What You
Need To Know About Establishment,
Maintenance, and Availability of
Records—Small Entity Compliance
Guide; Availability
AGENCY:
Food and Drug Administration,
HHS.
VerDate Mar<15>2010
16:47 Apr 03, 2014
Jkt 232001
ACTION:
Notification.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘What You Need To Know
About Establishment, Maintenance, and
Availability of Records—Small Entity
Compliance Guide’’ (SECG), which
updates an earlier guidance of the same
title. Previously, this guidance restated
the legal requirements of FDA’s
maintenance and establishment of
records regulation and served as that
regulation’s SECG. Because the FDA
Food Safety Modernization Act (FSMA)
amended FDA’s maintenance and
establishment of records regulation,
FDA issued an interim final rule (IFR)
amending certain regulations to be
consistent with the changes.
Accordingly, FDA is revising this
guidance to help any entity comply with
FDA’s maintenance and establishment
of records requirements, including the
amendments to these requirements
made by the IFR as finalized. This
guidance continues to serve as FDA’s
SECG.
DATES: Submit either electronic or
written comments on FDA guidances at
any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Outreach and Information Center,
Center for Food Safety and Applied
Nutrition, Food and Drug
Administration (HFS–009), 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 https://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., Office of
Compliance, Center for Food Safety and
Applied Nutrition (HFS–009), Food and
Drug Administration, 5100 Paint Branch
Pkwy., College Park, MD 20740, 240–
402–1611.
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
We are announcing the availability of
a guidance for industry entitled ‘‘What
You Need To Know About
Establishment, Maintenance, and
Availability of Records—Small Entity
Compliance Guide (SECG).’’ This
guidance is being issued consistent with
PO 00000
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18867
our good guidance practices regulation
(21 CFR 10.115(c)(2)). The guidance
represents our current thinking on the
establishment, maintenance, and
availability of 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 alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
FSMA (Pub. L. 111–353), among other
things, amended FDA’s records access
under section 414(a) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act). In the Federal Register of February
23, 2012 (77 FR 10658), FDA issued an
IFR that amended certain requirements
on the availability of records in the
regulation on the establishment and
maintenance of records in 21 CFR Part
1, Subpart J to be consistent with
amendments to the FD&C Act made by
FSMA. This interim final rule was
effective March 1, 2012.
Previously, this guidance restated the
legal requirements of FDA’s
establishment and maintenance of
records regulation at 21 CFR part 1,
Subpart J, implementing section 414 of
the FD&C Act, as added by the Public
Health Security and Bioterrorism
Preparedness and Response Act of 2002
(Pub. L. 107–188). This guidance also
served as FDA’s SECG for 21 CFR Part
1, Subpart J in accordance with section
212 of the Small Business Regulatory
Enforcement Fairness Act (Pub. L. 104–
121). Because section 101 of FSMA
amended section 414(a) of the FD&C
Act, FDA issued an IFR amending
certain requirements on the availability
of records in 21 CFR Part 1, Subpart J.
Elsewhere in this issue of the Federal
Register, we are issuing a final rule
adopting the IFR without changes. The
final rule is effective upon publication.
Accordingly, FDA is updating this SECG
to help any entity comply with the
requirements in 21 CFR part 1, Subpart
J, including the amendments to 21 CFR
Part 1, Subpart J made by the IFR and
adopted as final. This guidance
continues to serve as FDA’s SECG for 21
CFR part 1, Subpart J.
The Regulatory Flexibility Act (5
U.S.C. 601–612) requires Agencies to
determine whether a final rule will have
a significant impact on small entities
when an Agency issues a final rule
‘‘after being required . . . to publish a
general notice of proposed rulemaking.’’
Although FDA is not required to
perform a regulatory flexibility analysis
because, in accordance with 5 U.S.C.
553(b)(3)(B) and 21 CFR 10.40(e)(1), the
Agency found for good cause that use of
prior notice and comment procedures
were contrary to the public interest;
E:\FR\FM\04APP1.SGM
04APP1
Agencies
[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 https://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 https://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 https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the guidance at
either https://www.fda.gov/FoodGuidances or https://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