This site displays a prototype of a “Web 2.0” version of the daily Federal Register. It is not an official legal edition of the Federal Register, and does not replace the official print version or the official electronic version on GPO’s govinfo.gov.
The documents posted on this site are XML renditions of published Federal Register documents. Each document posted on the site includes a link to the corresponding official PDF file on govinfo.gov. This prototype edition of the daily Federal Register on FederalRegister.gov will remain an unofficial informational resource until the Administrative Committee of the Federal Register (ACFR) issues a regulation granting it official legal status. For complete information about, and access to, our official publications and services, go to About the Federal Register on NARA's archives.gov.
The OFR/GPO partnership is committed to presenting accurate and reliable regulatory information on FederalRegister.gov with the objective of establishing the XML-based Federal Register as an ACFR-sanctioned publication in the future. While every effort has been made to ensure that the material on FederalRegister.gov is accurately displayed, consistent with the official SGML-based PDF version on govinfo.gov, those relying on it for legal research should verify their results against an official edition of the Federal Register. Until the ACFR grants it official status, the XML rendition of the daily Federal Register on FederalRegister.gov does not provide legal notice to the public or judicial notice to the courts.
Food and Drug Administration, HHS.
Notice; reopening of the comment period.
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).
Submit either electronic or written comments by April 7, 2014.
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.
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.
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.
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.
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