Guidance for Industry: Food and Drug Administration Records Access Authority Under the Federal Food, Drug, and Cosmetic Act; Availability, 18866-18867 [2014-07551]

Download as PDF 18866 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 point font, at least 1/8 inch (.32 cm) below the first line, and is the text: ‘‘FLEX-FUEL VEHICLES.’’ The third line is in 10 point font, at least 1/8 inch (.32 cm) below the first line, and is the text ‘‘MAY HARM OTHER ENGINES.’’ * * * * * (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 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: (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 In the Federal Register of February 23, 2012 (77 FR 10753), we made available a draft guidance for industry entitled ‘‘FDA Records Access Authority Under Sections 414 and 704 of the Federal Food, Drug, and Cosmetic Act’’ and gave interested parties an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 We received several comments on the draft guidance.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 emcdonald on DSK67QTVN1PROD with PROPOSALS SUMMARY: VerDate Mar<15>2010 16:47 Apr 03, 2014 Jkt 232001 PO 00000 Frm 00021 Fmt 4702 Sfmt 4702 E:\FR\FM\04APP1.SGM 04APP1 EP04AP14.032</GPH> (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 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 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 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., 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 Frm 00022 Fmt 4702 Sfmt 4702 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]


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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