Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Special Protocol Assessment, 14404-14405 [2011-6092]

Download as PDF 14404 Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Notices ANNUAL BURDEN ESTIMATES Number of responses per respondent Annual number of respondents Average burden hours per response Total burden hours 10 20 40 1 2 1 1 2 2 100 70 70 140 70 1 1 1 1 1 1.5 1 0.25 0.25 0.25 Estimated Annual Burden Sub-total for Field Clearance ....................................................................... .............................. .............................. .............................. In-Depth Implementation Instrument: Master Topic Guide Interviews for General Staff and Community Members .................................................... Focus Group Discussion Guide with Frontline Staff ........ Focus Group Discussion Guide with Participating Youths Focus Group Discussion Guide with Control Group Schools About Counterfactuals .................................... 40 30 150 1 1 1 1.5 1.5 1.5 40 1 1 Estimated Annual Burden Sub-total for In-Depth Implementation .......................................................... .............................. .............................. Baseline Instrument: Baseline Instrument for study participants ....................... Administrative Data Collection instrument for Schools and Organizations ......................................................... 2500 1 100 1 Estimated Annual Burden Sub-total for Baseline ..... .............................. .............................. .............................. 1650 TOTAL Estimated Annual Burden ..................... jlentini on DSKJ8SOYB1PROD with NOTICES Field clearance instrument: Discussion Guide for use with Researchers, Policy Experts, and State Level Coordinators ............................. Discussion Guide for Use with Program Directors ........... Discussion Guide for Use with Program Staff ................. Focus Group Discussion Guide for use with Program Participants ................................................................... Discussion Guide for Use with School Administrators ..... Short Survey with Program Directors ............................... Short Survey with Program Staff ...................................... Short Survey with School Administrators ......................... .............................. .............................. .............................. 2640 In compliance with the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Administration for Children and Families is soliciting public comment on the specific aspects of the information collection described above. Copies of the proposed collection of information can be obtained and comments may be forwarded 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. E-mail address: OPREinfocollection@acf.hhs.gov. All requests should be identified by the title of the information collection. The Department specifically requests comments on (a) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency’s estimate of the burden of the proposed collection of information; (c) the quality, utility, and clarity of the information to be collected; and (d) VerDate Mar<15>2010 16:56 Mar 15, 2011 Jkt 223001 ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Consideration will be given to comments and suggestions submitted within 60 days of this publication. Dated: March 9, 2011. Steven M. Hanmer, Reports Clearance Officer. [FR Doc. 2011–5962 Filed 3–15–11; 8:45 am] BILLING CODE 4184–37–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2010–N–0541] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Special Protocol Assessment AGENCY: Food and Drug Administration, HHS. PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 10 80 80 460 60 45 225 40 .............................. .5 4 ACTION: 150 70 17.5 35 17.5 370 1250 400 Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Guidance for Industry on Special Protocol Assessment’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301– 796–3792, Elizabeth.Berbakos@fda.hhs.gov. SUMMARY: In the Federal Register of October 26, 2010 (75 FR 65636), the Agency announced that the proposed information collection had been submitted 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 0910–0470. The SUPPLEMENTARY INFORMATION: E:\FR\FM\16MRN1.SGM 16MRN1 Federal Register / Vol. 76, No. 51 / Wednesday, March 16, 2011 / Notices approval expires on February 28, 2014. A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. Dated: March 10, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–6091 Filed 3–15–11; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FR Doc. 2011–6092 Filed 3–15–11; 8:45 am] BILLING CODE 4160–01–P [Docket No.FDA–2011–N–0085] DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: March 10, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics Food and Drug Administration BILLING CODE 4160–01–P AGENCY: Food and Drug Administration [Docket No. FDA–2010–N–0468] Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Focus Groups About Drug Products, as Used by the Food and Drug Administration AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Focus Groups About Drug Products, as Used by the Food and Drug Administration’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Patent Term Restoration, Due Diligence Petitions, Filing, Format, and Content of Petitions’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. SUMMARY: FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301– 796–3792, Elizabeth.Berbakos@fda.hhs.gov. In the Federal Register of January 12, 2011 (76 FR 2127), the Agency announced that the proposed information collection had been submitted 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 0910–0233. The approval expires on February 28, 2014. A copy of the supporting statement for this information collection is available on the Internet at https:// www.reginfo.gov/public/do/PRAMain. jlentini on DSKJ8SOYB1PROD with NOTICES SUPPLEMENTARY INFORMATION: VerDate Mar<15>2010 18:34 Mar 15, 2011 Jkt 223001 FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, 301– 796–3792, Elizabeth.Berbakos@fda.hhs.gov. In the Federal Register of July 9, 2010 (75 FR 39541), the Agency announced that the proposed information collection had been submitted 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 0910–0677. The approval expires on July 31, 2012. 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: Dated: March 10, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011–6093 Filed 3–15–11; 8:45 am] BILLING CODE 4160–01–P PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 Food and Drug Administration, HHS. [Docket No. FDA–2010–N–0122] DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: 14405 ACTION: Notice. The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the proposed extension of the collection of information concerning the guidance for industry on cooperative manufacturing arrangements for licensed biologics. DATES: Submit either electronic or written comments on the collection of information by May 16, 2011. ADDRESSES: Submit electronic comments on the collection of information to: https:// www.regulations.gov. Submit written comments on the collection of information to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Juanmanuel Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr, PI50–400B, Rockville, MD 20850, 301– 796–3794, Juanmanuel.Vilela@fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501–3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. ‘‘Collection of information’’ is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide SUMMARY: E:\FR\FM\16MRN1.SGM 16MRN1

Agencies

[Federal Register Volume 76, Number 51 (Wednesday, March 16, 2011)]
[Notices]
[Pages 14404-14405]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-6092]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0541]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approval; Guidance for Industry on Special 
Protocol Assessment

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing that a 
collection of information entitled ``Guidance for Industry on Special 
Protocol Assessment'' has been approved by the Office of Management and 
Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of 
Information Management, Food and Drug Administration, 1350 Piccard Dr., 
PI50-400B, Rockville, MD 20850, 301-796-3792, 
Elizabeth.Berbakos@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 26, 2010 
(75 FR 65636), the Agency announced that the proposed information 
collection had been submitted 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 0910-0470. 
The

[[Page 14405]]

approval expires on February 28, 2014. A copy of the supporting 
statement for this information collection is available on the Internet 
at https://www.reginfo.gov/public/do/PRAMain.

    Dated: March 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-6092 Filed 3-15-11; 8:45 am]
BILLING CODE 4160-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.