Document ID: FDA-2010-D-0503-0017
Agency: fda
Document Type: Notice
Title: Guidance for Clinical Investigators, Sponsors, and Institutional Review
Boards on Investigational New Drug Applications—Determining Whether Human Research Studies Can Be Conducted Without an Investigational New Drug Application; Reopening of the Comment Period
Posted Date: 2014-02-06T05:00Z

[Federal Register Volume 79, Number 25 (Thursday, February 6, 2014)]
[Notices]
[Page 7204]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02550]

[[Page 7204]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0503]

Guidance for Clinical Investigators, Sponsors, and Institutional 
Review Boards on Investigational New Drug Applications--Determining 
Whether Human Research Studies Can Be Conducted Without an 
Investigational New Drug Application; Reopening of the Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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SUMMARY: The Food and Drug Administration (FDA or we) is reopening the 
comment period for the final guidance for clinical investigators, 
sponsors, and institutional review boards (IRBs) entitled 
``Investigational New Drug Applications (INDs)--Determining whether 
Human Research Studies can be Conducted without an IND,'' published in 
the Federal Register of September 10, 2013 (78 FR 55262). We are 
reopening the comment period only with respect to those subsections of 
the final guidance that address the applicability of the IND 
regulations to clinical research studies involving cosmetics and foods 
(including dietary supplements).

DATES: Submit either electronic or written comments by April 7, 2014.

ADDRESSES: Submit electronic comments on the final 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: Paul L. Ferrari, Center for Food 
Safety and Applied Nutrition (HFS-024), Food and Drug Administration, 
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1722.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of October 14, 2010 (75 FR 63189), we 
published a notice announcing the availability of a draft guidance 
entitled ``Guidance for Industry: Investigational New Drug Applications 
(INDs)--Determining whether Human Research Studies can be Conducted 
without an IND'' (``the draft guidance''). In the Federal Register of 
September 10, 2013 (78 FR 55262), we published a notice announcing the 
availability of the final version of the guidance, entitled ``Guidance 
for Clinical Investigators, Sponsors, and IRBs: Investigational New 
Drug Applications (INDs)--Determining whether Human Research Studies 
can be Conducted without an IND'' (``the final guidance''). We are 
reopening the comment period only with respect to those subsections of 
the final guidance that address the applicability of the IND 
regulations to clinical research studies involving cosmetics and foods 
(including dietary supplements), in response to requests from 
interested persons.

II. Request for Comments

    Following publication of the September 10, 2013, Federal Register 
notice of availability of the final guidance, we received 
correspondence asking us to provide for further opportunity to comment 
on subsections C (``Cosmetics'') and D (``Foods'') of section VI 
(``Specific Issues Concerning the Application of the IND Regulations'') 
of the final guidance. The correspondence explained that more time was 
needed to review the guidance and consider its effect on researchers 
and health care providers, among others. In response to these requests, 
we have decided to reopen the comment period with respect to the foods 
and cosmetics subsections of the final guidance for 60 days. 
Accordingly, we invite comment on subsections VI.C and VI.D by April 7, 
2014.

III. How To Submit Comments

    Interested persons may submit either electronic comments regarding 
subsections VI.C and VI.D of the final guidance 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.

    Dated: January 31, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-02550 Filed 2-5-14; 8:45 am]
BILLING CODE 4160-01-P