Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information, 3209-3210 [2014-00872]

Download as PDF 3209 Federal Register / Vol. 79, No. 12 / Friday, January 17, 2014 / Notices and provide accurate and useful opinions. The information is read and analyzed to develop and issue an advisory opinion to the individual or entity that submitted the information. Form Number: CMS–R–216 (OCN: 0938–0714); Frequency: Occasionally; Affected Public: Private sector (Business or other for-profits and Not-for-profit institutions); Number of Respondents: 25; Total Annual Responses: 25; Total Annual Hours: 500. (For policy questions regarding this collection contact Jacqueline Proctor at 410–786– 0661). 3. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: CY 2015 Plan Benefit Package (PBP), Formulary, and Supporting Regulations; Use: We require Medicare Advantage and Prescription Drug Plan organizations submit a completed plan benefit package (PBP) and formulary as part of the annual bidding process. During this process, organizations prepare their proposed plan benefit packages for the upcoming contract year and submit them to us for review and approval. We publish beneficiary education information using a variety of formats. Specific education initiatives that utilize PBP and formulary data include web application tools on medicare.gov and the plan benefit insert in the Medicare & You handbook. In addition, organizations utilize the PBP data to generate their Summary of Benefits marketing information. The package has been revised subsequent to the publication of the 60-day Federal Register notice (78 FR 65656); Form Number: CMS–R–262 (OCN: 0938– 0763); Frequency: Yearly; Affected Public: Private sector (Business or other for-profits and Not-for-profit institutions); Number of Respondents: 652; Total Annual Responses: 6,265; Total Annual Hours: 57,477. (For policy questions regarding this collection contact Kristy Holtje at 410–786–2209). Dated: January 14, 2014. Martique Jones, Deputy Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2014–00915 Filed 1–16–14; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Adults with Child Welfare Involvement At-Risk of Homelessness. OMB No.: New Collection. Description: The Administration for Children and Families (ACF), U.S. Department of Health and Human Services intends to collect data for an process evaluation of the ‘‘Planning Grants to Develop a Model Intervention for Youth/Young Adults with Child Welfare Involvement at-Risk of Homelessness’’ program. This two year program, funded by the Children’s Bureau within ACF, will support planning grants to develop a model for intervening with youth who have experienced time in foster care and are most likely to have a challenging transition to adulthood, including the possibility of homelessness or unstable housing. Respondents: Members of the planning team, which includes: Directors and staff from grantee agencies and partner agencies. Partner agencies may vary by site, but they are expected to include child welfare, mental health, and youth housing/homelessness agencies. Submission for OMB Review; Comment Request Title: Planning Grants To Develop a Model Intervention for Youth/Young ANNUAL BURDEN ESTIMATES Total number of respondents Instrument emcdonald on DSK67QTVN1PROD with NOTICES Survey Sampling Form ........................................................ Survey of Organizational Readiness and Partnership ........ Estimated Total Annual Burden Hours: 275. Additional Information: Copies of the proposed collection may be obtained by writing to the Administration for Children and Families, Office of Planning, Research and Evaluation, 370 L’Enfant Promenade SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. All requests should be identified by the title of the information collection. Email address: OPREinfocollection@acf.hhs.gov. OMB Comment: OMB is required to make a decision concerning the collection of information between 30 and 60 days after publication of this document in the Federal Register. Therefore, a comment is best assured of having its full effect if OMB receives it within 30 days of publication. Written VerDate Mar<15>2010 18:31 Jan 16, 2014 Jkt 232001 Annual number of respondents 36 540 18 270 comments and recommendations for the proposed information collection should be sent directly to the following: Office of Management and Budget, Paperwork Reduction Project, Email: OIRA_ SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for Children and Families. Karl Koerper, OPRE Reports Clearance Officer. [FR Doc. 2014–00854 Filed 1–16–14; 8:45 am] BILLING CODE 4184–01–P PO 00000 Annual number of responses per respondent Average burden hours per response 1 1 Annual burden hours .25 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–D–0319] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing SUMMARY: Frm 00047 Fmt 4703 Sfmt 4703 5 270 E:\FR\FM\17JAN1.SGM 17JAN1 3210 Federal Register / Vol. 79, No. 12 / Friday, January 17, 2014 / Notices that a collection of information entitled ‘‘Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information’’ 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 13, 2012, the Agency submitted a proposed collection of information entitled ‘‘Guidance for Industry and Food and Drug Administration Staff on Dear Health Care Provider Letters: Improving Communication of Important Safety Information’’ 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 0910–0754. 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 13, 2014. Leslie Kux, Assistant Commissioner for Policy. BILLING CODE 4160–01–P Food and Drug Administration, HHS. emcdonald on DSK67QTVN1PROD with NOTICES Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Premarket Approval of Medical Devices—21 CFR Part 814’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. 17:00 Jan 16, 2014 Jkt 232001 Dated: January 13, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–00869 Filed 1–16–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0618] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Reporting and Recordkeeping for Electronic Products—General Requirements AGENCY: Food and Drug Administration ACTION: [Docket No. FDA–2013–N–0804] SUMMARY: Food and Drug Administration, Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Premarket Notification Submission 510(k), Subpart E’’ 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 12, 2013, the Agency submitted a proposed collection of information entitled ‘‘Premarket Notification Submission 510(k), Subpart E’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is SUMMARY: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Approval of Medical Devices—21 CFR Part 814 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 0910–0120. The approval expires on January, 31 2017. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: [Docket No. FDA–2013–N–0485] VerDate Mar<15>2010 BILLING CODE 4160–01–P HHS. Food and Drug Administration SUMMARY: [FR Doc. 2014–00870 Filed 1–16–14; 8:45 am] AGENCY: DEPARTMENT OF HEALTH AND HUMAN SERVICES ACTION: Dated: January 13, 2014. Leslie Kux, Assistant Commissioner for Policy. Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Premarket Notification Submission 510(k) [FR Doc. 2014–00872 Filed 1–16–14; 8:45 am] AGENCY: 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 22, 2013, the Agency submitted a proposed collection of information entitled ‘‘Premarket Approval of Medical Devices—21 CFR Part 814’’ 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 0910–0231. The approval expires on January 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. FOR FURTHER INFORMATION CONTACT: PO 00000 Frm 00048 Fmt 4703 Sfmt 4703 Food and Drug Administration, HHS. Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Reporting and Recordkeeping for Electronic Products—General Requirements’’ 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 20, 2013, the Agency submitted a proposed collection of information entitled ‘‘Reporting and Recordkeeping for Electronic Products— General Requirements’’ 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 0910–0025. The approval expires on January 31, 2017. A copy of the supporting statement for this information collection is available on E:\FR\FM\17JAN1.SGM 17JAN1

Agencies

[Federal Register Volume 79, Number 12 (Friday, January 17, 2014)]
[Notices]
[Pages 3209-3210]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-00872]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0319]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry and Food and 
Drug Administration Staff on Dear Health Care Provider Letters: 
Improving Communication of Important Safety Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing

[[Page 3210]]

that a collection of information entitled ``Guidance for Industry and 
Food and Drug Administration Staff on Dear Health Care Provider 
Letters: Improving Communication of Important Safety Information'' 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 13, 2012, the Agency submitted 
a proposed collection of information entitled ``Guidance for Industry 
and Food and Drug Administration Staff on Dear Health Care Provider 
Letters: Improving Communication of Important Safety Information'' 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 0910-0754. 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 13, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00872 Filed 1-16-14; 8:45 am]
BILLING CODE 4160-01-P

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