81_FR_10911 81 FR 10870 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting

81 FR 10870 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 41 (March 2, 2016)

Page Range10870-10870
FR Document2016-04576

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Federal Register, Volume 81 Issue 41 (Wednesday, March 2, 2016) 
[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Notices]
[Page 10870]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-04576]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0110]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Medical Device Reporting: 
Manufacturer, Importer, User Facility, and Distributor Reporting

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 ``Medical Device Reporting: 
Manufacturer, Importer, User Facility, and Distributor Reporting'' 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, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [email protected].

SUPPLEMENTARY INFORMATION: On August 31, 2015, the Agency submitted a 
proposed collection of information entitled ``Medical Device Reporting: 
Manufacturer, Importer, User Facility, and Distributor Reporting'' 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 0910-0437. The approval expires on December 
31, 2018. A copy of the supporting statement for this information 
collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: February 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04576 Filed 3-1-16; 8:45 am]
 BILLING CODE 4164-01-P

10870 Federal Register / Vol. 81, No. 41 / Wednesday, March 2, 2016 / Notices TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued Number of Average Number of Total annual Activity responses per burden per Total Hours respondents responses respondent response Main Study Number to complete the screener (assumes 50% eligible) ..... 3,300 1 3,300 0.08 (5 min.) ..... 264 Number of completes ................................................................ 1,650 1 1,650 .42 (25 min.) ..... 693 Total Hours ........................................................................ ...................... ........................ ...................... ........................... 1,149 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The following references have been 10. Garretson JA, Niedrich RW., ‘‘Spokes- SUMMARY: The Food and Drug placed on display in the Division of Characters: Creating Character Trust and Administration (FDA) is announcing Dockets Management (see ADDRESSES) Positive Brand Attitudes,’’ Journal of that a collection of information entitled Advertising, 2004;33(2):25–36. and may be seen by interested persons ‘‘Medical Device Reporting: 11. Delbaere M, McQuarrie EF, Phillips BJ, between 9 a.m. and 4 p.m., Monday ‘‘Personification in Advertising: Using a Manufacturer, Importer, User Facility, through Friday, and are available Visual Metaphor to Trigger and Distributor Reporting’’ has been electronically at http:// Anthropomorphism,’’ Journal of approved by the Office of Management www.regulations.gov. Advertising, 2011;40(1):121–130. and Budget (OMB) under the Paperwork 12. Hart PM, Jones SR, Royne MB, ‘‘The References Reduction Act of 1995. Human Lens: How Anthropomorphic 1. Callcott MF, Lee W. ‘‘Establishing the Reasoning Varies by Product Complexity FOR FURTHER INFORMATION CONTACT: FDA Spokes-Character in Academic Inquiry: and Enhances Personal Value,’’ Journal PRA Staff, Office of Operations, Food Historical Overview and Framework for of Marketing Management, 2013;29(1– 2):105–121. and Drug Administration, 8455 Definition,’’ Advances in Consumer 13. Moyer-Guse E, Mahood C, Brookes S., Colesville Rd., COLE–14526, Silver Research, 1995;22:144–151. 2. Bell JA. Creativity, TV Commercial ‘‘Entertainment-Education in the Context Spring, MD 20993–0002, Popularity, and Advertising of Humor: Effects on Safer Sex Intentions PRAStaff@fda.hhs.gov. Expenditures, Internationl Journal of and Risk Perceptions,’’ Health Advertising, 1992;11(2):165–72. Communication, 2011;26(8):765–774. SUPPLEMENTARY INFORMATION: On August 3. Heiser RS, Sierra JJ, Torres IM. ‘‘Creativity 14. Lang A., ‘‘The Limited Capacity Model of 31, 2015, the Agency submitted a Via Cartoon Spokespeople in Print Ads: Motivated Mediated Message proposed collection of information Capitalizing on the Distinctiveness Processing,’’ The Sage Handbook of entitled ‘‘Medical Device Reporting: Effect,’’ Journal of Advertising, Mass Media Effects, New York: Sage;2009:193–204. Manufacturer, Importer, User Facility, 2008;37(4):75–85. 4. Luo JT, McGoldrick P, Beatty S, et al, ‘‘On- 15. Garretson JA, Burton S., ‘‘The Role of and Distributor Reporting’’ to OMB for Screen Characters: Their Design and Spokescharacters as Advertisement and review and clearance under 44 U.S.C. Influence on Consumer Trust,’’ Journal Package Cues in Integrated Marketing 3507. An Agency may not conduct or of Services Marketing, 2006;20(2):112– Campaigns,’’ Journal of Marketing, sponsor, and a person is not required to 24. 2005;69(4):118–132. respond to, a collection of information 5. Clayton RB, Lesher G. ‘‘The Uncanny 16. Lang A., ‘‘Using the Limited Capacity Model of Motivated Mediated Message unless it displays a currently valid OMB Valley: The Effects of Rotoscope Processing to Design Effective Cancer control number. OMB has now Animation on Motivational Processing of Depression Drug Messages,’’ Journal of Communication Messages,’’ Journal of approved the information collection and Broadcasting and Electronic Media, Communication, 2006;56:557–580. has assigned OMB control number 2015;59(1):57–75. Dated: February 23, 2016. 0910–0437. The approval expires on 6. Bhutada NS, Rollins BL, Perri M. Leslie Kux, December 31, 2018. A copy of the ‘‘Animation in Print Direct-to-Consumer supporting statement for this Associate Commissioner for Policy. Advertising of Prescription Drugs: information collection is available on Impact on Consumers,’’ at the 32d [FR Doc. 2016–04569 Filed 3–1–16; 8:45 am] Association for Marketing and BILLING CODE 4164–01–P the Internet at http://www.reginfo.gov/ Healthcare Research Annual Meeting public/do/PRAMain. and Conference, February 27-March 1, Dated: February 25, 2016. 2013, Big Sky, MT. DEPARTMENT OF HEALTH AND 7. Pashupati K. ‘‘Beavers, Bubbles, Bees, and Leslie Kux, HUMAN SERVICES Moths: An Examination of Animated Associate Commissioner for Policy. Spokescharacters in DTC Prescription Food and Drug Administration [FR Doc. 2016–04576 Filed 3–1–16; 8:45 am] Drug Advertisements and Web sites,’’ BILLING CODE 4164–01–P Journal of Advertising Research, [Docket No. FDA–2012–N–0110] 2009;49(3):373–93. 8. Chandler J, Schwarz N. ‘‘Use Does Not Agency Information Collection Wear Ragged the Fabric of Friendship: Activities; Announcement of Office of Thinking of Objects as Alive Makes Management and Budget Approval; mstockstill on DSK4VPTVN1PROD with NOTICES People Less Willing to Replace Them,’’ Medical Device Reporting: Journal of Consumer Psychology, Manufacturer, Importer, User Facility, 2010;20(2):138–145. and Distributor Reporting 9. Callcott MF, Phillips BJ., ‘‘Observations: Elves Make Good Cookies: Creating AGENCY: Food and Drug Administration, Likeable Spokescharacter Advertising,’’ HHS. Journal of Advertising Research, ACTION: Notice. 1996;36(5):73–79. VerDate Sep<11>2014 19:10 Mar 01, 2016 Jkt 238001 PO 00000 Frm 00044 Fmt 4703 Sfmt 9990 E:\FR\FM\02MRN1.SGM 02MRN1


Document Created: 2018-02-02 15:04:21
Document Modified: 2018-02-02 15:04:21
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
ContactFDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, [email protected]
FR Citation81 FR 10870 
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