Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans, 3826 [2014-01219]

Download as PDF 3826 Federal Register / Vol. 79, No. 15 / Thursday, January 23, 2014 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration Food and Drug Administration [Docket No. FDA–2013–N–0403] [Docket No. FDA–2013–N–0663] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Protection of Human Subjects: Informed Consent; Institutional Review Boards Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans AGENCY: Food and Drug Administration, HHS. ACTION: [Docket No. FDA–2013–D–1574] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices).’’ FDA is issuing this draft guidance to update the policy regarding the use of animal-derived material in medical device manufacturing. These animal-derived materials may carry a risk of transmitting infectious disease when improperly collected, stored, or manufactured. The guidance describes the information you should document at the manufacturing facility and include in any premarket submissions. This draft guidance is not final nor is it in effect at this time. 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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 23, 2014. ADDRESSES: Submit written requests for single copies of the draft guidance document entitled ‘‘Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices)’’ to the Division of Small Manufacturers, International and Consumer Assistance, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 301–847– 8149. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit electronic comments on the draft 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. Identify SUMMARY: Notice. AGENCY: Food and Drug Administration, HHS. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Protection of Human Subjects: Informed Consent; Institutional Review Boards’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: On July 30, 2013, the Agency submitted a proposed collection of information entitled ‘‘Protection of Human Subjects: Informed Consent; Institutional Review Boards’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0755. The approval expires on December 31, 2016. A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. SUPPLEMENTARY INFORMATION: Dated: January 17, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–01310 Filed 1–22–14; 8:45 am] BILLING CODE 4160–01–P sroberts on DSK5SPTVN1PROD with NOTICES Medical Devices Containing Materials Derived From Animal Sources (Except for In Vitro Diagnostic Devices); Draft Guidance for Industry and Food and Drug Administration Staff; Availability ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. FOR FURTHER INFORMATION CONTACT: On November 13, 2013, the Agency submitted a proposed collection of information entitled ‘‘Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0672. The approval expires on December 31, 2016. A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. SUPPLEMENTARY INFORMATION: Dated: January 16, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–01219 Filed 1–22–14; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 21:50 Jan 22, 2014 Jkt 232001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\23JAN1.SGM 23JAN1

Agencies

[Federal Register Volume 79, Number 15 (Thursday, January 23, 2014)]
[Notices]
[Page 3826]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-01219]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0663]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Investigational New Drug Safety 
Reporting Requirements for Human Drug and Biological Products and 
Safety Reporting Requirements for Bioavailability and Bioequivalence 
Studies in Humans

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Investigational New Drug Safety 
Reporting Requirements for Human Drug and Biological Products and 
Safety Reporting Requirements for Bioavailability and Bioequivalence 
Studies in Humans'' has been approved by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On November 13, 2013, the Agency submitted a 
proposed collection of information entitled ``Investigational New Drug 
Safety Reporting Requirements for Human Drug and Biological Products 
and Safety Reporting Requirements for Bioavailability and 
Bioequivalence Studies in Humans'' to OMB for review and clearance 
under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a 
person is not required to respond to, a collection of information 
unless it displays a currently valid OMB control number. OMB has now 
approved the information collection and has assigned OMB control number 
0910-0672. The approval expires on December 31, 2016. A copy of the 
supporting statement for this information collection is available on 
the Internet at https://www.reginfo.gov/public/do/PRAMain.

    Dated: January 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-01219 Filed 1-22-14; 8:45 am]
BILLING CODE 4160-01-P

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