Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device Reporting: Manufacturer, Importer, User Facility, and Distributor Reporting, 10870 [2016-04576]
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10870
Federal Register / Vol. 81, No. 41 / Wednesday, March 2, 2016 / Notices
TABLE 3—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
respondents
Activity
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total Hours
Main Study
Number to complete the screener (assumes 50% eligible) .....
Number of completes ................................................................
3,300
1,650
1
1
3,300
1,650
0.08 (5 min.) .....
.42 (25 min.) .....
264
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
placed on display in the Division of
Dockets Management (see ADDRESSES)
and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday
through Friday, and are available
electronically at https://
www.regulations.gov.
mstockstill on DSK4VPTVN1PROD with NOTICES
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Via Cartoon Spokespeople in Print Ads:
Capitalizing on the Distinctiveness
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2008;37(4):75–85.
4. Luo JT, McGoldrick P, Beatty S, et al, ‘‘OnScreen Characters: Their Design and
Influence on Consumer Trust,’’ Journal
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5. Clayton RB, Lesher G. ‘‘The Uncanny
Valley: The Effects of Rotoscope
Animation on Motivational Processing of
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Broadcasting and Electronic Media,
2015;59(1):57–75.
6. Bhutada NS, Rollins BL, Perri M.
‘‘Animation in Print Direct-to-Consumer
Advertising of Prescription Drugs:
Impact on Consumers,’’ at the 32d
Association for Marketing and
Healthcare Research Annual Meeting
and Conference, February 27-March 1,
2013, Big Sky, MT.
7. Pashupati K. ‘‘Beavers, Bubbles, Bees, and
Moths: An Examination of Animated
Spokescharacters in DTC Prescription
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2009;49(3):373–93.
8. Chandler J, Schwarz N. ‘‘Use Does Not
Wear Ragged the Fabric of Friendship:
Thinking of Objects as Alive Makes
People Less Willing to Replace Them,’’
Journal of Consumer Psychology,
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9. Callcott MF, Phillips BJ., ‘‘Observations:
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Likeable Spokescharacter Advertising,’’
Journal of Advertising Research,
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11. Delbaere M, McQuarrie EF, Phillips BJ,
‘‘Personification in Advertising: Using a
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Anthropomorphism,’’ Journal of
Advertising, 2011;40(1):121–130.
12. Hart PM, Jones SR, Royne MB, ‘‘The
Human Lens: How Anthropomorphic
Reasoning Varies by Product Complexity
and Enhances Personal Value,’’ Journal
of Marketing Management, 2013;29(1–
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13. Moyer-Guse E, Mahood C, Brookes S.,
‘‘Entertainment-Education in the Context
of Humor: Effects on Safer Sex Intentions
and Risk Perceptions,’’ Health
Communication, 2011;26(8):765–774.
14. Lang A., ‘‘The Limited Capacity Model of
Motivated Mediated Message
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Sage;2009:193–204.
15. Garretson JA, Burton S., ‘‘The Role of
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Dated: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–04569 Filed 3–1–16; 8:45 am]
BILLING CODE 4164–01–P
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.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002,
PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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 https://www.reginfo.gov/
public/do/PRAMain.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: February 25, 2016.
Leslie Kux,
Associate Commissioner for Policy.
Food and Drug Administration
[FR Doc. 2016–04576 Filed 3–1–16; 8:45 am]
[Docket No. FDA–2012–N–0110]
BILLING CODE 4164–01–P
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:
PO 00000
Notice.
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]]>Agencies
[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Notices]
[Page 10870]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-04576]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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, PRAStaff@fda.hhs.gov.
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 https://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
