Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims, 76841 [2013-30146]

Download as PDF Federal Register / Vol. 78, No. 244 / Thursday, December 19, 2013 / Notices information collection is available on the Internet at http://www.reginfo.gov/ public/do/PRAMain. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: December 12, 2013. Leslie Kux, Assistant Commissioner for Policy. Food and Drug Administration [Docket No. FDA–2013–N–0796] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Testing Communications on Medical Devices and Radiation-Emitting Products [FR Doc. 2013–30147 Filed 12–18–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: Food and Drug Administration Food and Drug Administration, HHS. Notice. [Docket No. FDA–2008–D–0150] ACTION: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims SUMMARY: AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims’’ 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 September 10, 2013, the Agency submitted a proposed collection of information entitled ‘‘Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims’’ 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 0910–0670. The approval expires on December 31, 2016. A copy of the supporting statement for this information collection is available on the Internet at http:// www.reginfo.gov/public/do/PRAMain. emcdonald on DSK67QTVN1PROD with NOTICES SUMMARY: Dated: December 12, 2013. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2013–30146 Filed 12–18–13; 8:45 am] BILLING CODE 4160–01–P VerDate Mar<15>2010 16:41 Dec 18, 2013 Jkt 232001 The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by January 21, 2014. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0678. Also include the FDA docket number found in brackets in the heading of this document. FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. FOR FURTHER INFORMATION CONTACT: Testing Communications on Medical Devices and Radiation-Emitting Products—(OMB Control Number 0910– 0678)—(Extension) FDA is authorized by section 1003(d)(2)(D) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)) to conduct educational and public information programs relating to the safety of regulated medical devices and radiation-emitting products. FDA must conduct needed research to ensure that such programs have the highest likelihood of being effective. Improving communications about medical devices and radiation- PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 76841 emitting products will involve many research methods, including individual indepth interviews, mall-intercept interviews, focus groups, selfadministered surveys, gatekeeper reviews, and omnibus telephone surveys. The information collected will serve three major purposes. First, as formative research it will provide critical knowledge needed about target audiences to develop messages and campaigns about medical device and radiation-emitting product use. Knowledge of consumer and health care professional decision making processes will provide the better understanding of target audiences that FDA needs to design effective communication strategies, messages, and labels. These communications will aim to improve public understanding of the risks and benefits of using medical devices and radiation-emitting products by providing users with a better context in which to place risk information more completely. Second, as initial testing, it will allow FDA to assess the potential effectiveness of messages and materials in reaching and successfully communicating with their intended audiences. Testing messages with a sample of the target audience will allow FDA to refine messages while still in the developmental stage. Respondents will be asked to give their reaction to the messages in either individual or group settings. Third, as evaluative research, it will allow FDA to ascertain the effectiveness of the messages and the distribution method of these messages in achieving the objectives of the message campaign. Evaluation of campaigns is a vital link in continuous improvement of communications at FDA. Annually, FDA projects about 30 studies using a variety of research methods and lasting an average of 0.17 hours each (varying from 0.08–1.5 hours). FDA estimates the burden of this collection of information based on prior recent experience with the various types of data collection methods described earlier. FDA is requesting this burden so as not to restrict the Agency’s ability to gather information on public sentiment for its proposals in its regulatory and communications programs. In the Federal Register of July 9, 2013 (78 FR 41066), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received. FDA estimates the burden of this collection of information as follows: E:\FR\FM\19DEN1.SGM 19DEN1

Agencies

[Federal Register Volume 78, Number 244 (Thursday, December 19, 2013)]
[Notices]
[Page 76841]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-30146]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0150]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry on 
Hypertension Indication: Drug Labeling for Cardiovascular Outcome 
Claims

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 ``Guidance for Industry on 
Hypertension Indication: Drug Labeling for Cardiovascular Outcome 
Claims'' 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 September 10, 2013, the Agency submitted 
a proposed collection of information entitled ``Guidance for Industry 
on Hypertension Indication: Drug Labeling for Cardiovascular Outcome 
Claims'' 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 0910-0670. The approval 
expires on December 31, 2016. A copy of the supporting statement for 
this information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: December 12, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-30146 Filed 12-18-13; 8:45 am]
BILLING CODE 4160-01-P