Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Communicating Composite Scores in Direct-to-Consumer Advertising, 49271 [2013-19523]

Download as PDF Federal Register / Vol. 78, No. 156 / Tuesday, August 13, 2013 / Notices Regulatory Secretariat (MVCB), 1800 F Street NW., 2nd Floor, Washington, DC 20405–0001, telephone 202–501–4755. ATTN: Hada Flowers/IC 3090–00xx; MyUSA. Please cite OMB Control No. 3090–XXXX; MyUSA, in all correspondence. Dated: August 5, 2013. Leslie Kux, Assistant Commissioner for Policy. Dated: August 8, 2013. Casey Coleman, Chief Information Officer. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2013–19523 Filed 8–12–13; 8:45 am] BILLING CODE 4160–01–P Food and Drug Administration [FR Doc. 2013–19633 Filed 8–12–13; 8:45 am] BILLING CODE 6820–34–P [Docket No. FDA–2013–D–0880] DEPARTMENT OF HEALTH AND HUMAN SERVICES Draft Guidance for Industry on Frequently Asked Questions About Medical Foods; Second Edition; Availability AGENCY: Food and Drug Administration ACTION: [Docket No. FDA–2012–N–0892] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Communicating Composite Scores in Direct-to-Consumer Advertising AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Communicating Composite Scores in Direct-to-Consumer (DTC) Advertising’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50– 400B, Rockville, MD 20850, 301–796– 5156, daniel.gittleson@fda.hhs.gov. On May 16, 2013, the Agency submitted a proposed collection of information entitled ‘‘Communicating Composite Scores in Direct-to-Consumer (DTC) Advertising’’ 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 0910–0743. The approval expires on July 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. ehiers on DSK2VPTVN1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 15:31 Aug 12, 2013 Jkt 229001 Food and Drug Administration, HHS. Notice. The Food and Drug Administration (FDA or we) is announcing the availability of the draft guidance for industry entitled ‘‘Frequently Asked Questions About Medical Foods; Second Edition.’’ The draft guidance, when finalized, will provide responses to additional questions regarding the definition, labeling, and availability of medical foods and updates to some of the existing responses. 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 the draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by October 15, 2013. SUMMARY: Submit written requests for single copies of this draft guidance to the Office of Nutrition, Labeling, and Dietary Supplements, Center for Food Safety and Applied Nutrition (HFS– 850), 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 draft 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. FOR FURTHER INFORMATION CONTACT: Shawne Suggs-Anderson, Center for Food Safety and Applied Nutrition (HFS–850), Food and Drug Administration, 5100 Paint Branch ADDRESSES: PO 00000 Frm 00022 Fmt 4703 Sfmt 4703 49271 Pkwy., College Park, MD 20740, 240– 402–1783. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a draft guidance for industry entitled ‘‘Frequently Asked Questions About Medical Foods; Second Edition.’’ This draft guidance is being issued consistent with our good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent FDA’s current thinking on medical foods. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternate approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. We originally issued this guidance in May 2007. This draft guidance provides responses to additional questions regarding the definition, labeling, and availability of medical foods and updates to some of the existing responses. II. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information 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) (the PRA). The collections of information in sections 101.3, 101.4, 101.5, 101.15, and 101.105 of 21 CFR part 101 have been approved under OMB control number 0910–0381. The labeling provisions recommended in this draft guidance in response to Question 13 are not subject to review by OMB because they do not constitute a ‘‘collection of information’’ under the PRA. Rather, the recommended labeling is a ‘‘public disclosure of information originally supplied by the Federal government to the recipient for the purpose of disclosure to the public’’ (5 CFR 1320.3(c)(2)). III. Comments Interested persons may submit either electronic comments regarding this draft guidance 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. E:\FR\FM\13AUN1.SGM 13AUN1

Agencies

[Federal Register Volume 78, Number 156 (Tuesday, August 13, 2013)]
[Notices]
[Page 49271]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-19523]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0892]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Communicating Composite Scores in 
Direct-to-Consumer Advertising

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 ``Communicating Composite Scores in 
Direct-to-Consumer (DTC) Advertising'' has been approved by the Office 
of Management and Budget (OMB) under the Paperwork Reduction Act of 
1995.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-5156, 
daniel.gittleson@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: On May 16, 2013, the Agency submitted a 
proposed collection of information entitled ``Communicating Composite 
Scores in Direct-to-Consumer (DTC) Advertising'' 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 
0910-0743. The approval expires on July 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: August 5, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-19523 Filed 8-12-13; 8:45 am]
BILLING CODE 4160-01-P
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