Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Special Protocol Assessment, 34470-34471 [E7-12056]

Download as PDF 34470 Federal Register / Vol. 72, No. 120 / Friday, June 22, 2007 / Notices will vote and the Committee will make its recommendation. III. Registration Instructions The Coverage and Analysis Group is coordinating meeting registration. While there is no registration fee, individuals must register to attend. Register by contacting Maria Ellis at the address specified in the ADDRESSES section of this notice. Please provide your name, address, organization, telephone and fax numbers, and e-mail address. You will receive a registration confirmation with instructions for your arrival at the CMS complex. You will be notified if the seating capacity has been reached. This meeting is located on Federal property; therefore, for security reasons, any individuals wishing to attend this meeting must register by 5 p.m. d.s.t. on September 5, 2007. IV. Security, Building, and Parking Guidelines This meeting will be held in a Federal government building; therefore, Federal security measures are applicable. In planning your arrival time, we recommend allowing additional time to clear security. In order to gain access to the building and grounds, individuals must present photographic identification to the Federal Protective Service or Guard Service personnel before being allowed entrance. Security measures also include inspection of vehicles, inside and out, at the entrance to the grounds. In addition, all individuals entering the building must pass through a metal detector. All items brought to CMS, whether personal or for the purpose of demonstration or to support a demonstration, are subject to inspection. We cannot assume responsibility for coordinating the receipt, transfer, transport, storage, setup, safety, or timely arrival of any personal belongings or items used for demonstration or to support a demonstration. Parking permits and instructions will be issued upon arrival. Note: Individuals who are not registered in advance will not be permitted to enter the building and will be unable to attend the meeting. The public may not enter the building earlier than 30 to 45 minutes prior to the convening of the meeting. All visitors must be escorted in areas other than the lower and first floor levels in the Central Building. Authority: 5 U.S.C. App. 2, section 10(a). (Catalog of Federal Domestic Assistance Program No. 93.774, Medicare— Supplementary Medical Insurance Program) Dated: June 11, 2007. Barry M. Straube, Chief Medical Officer and Director, Office of Clinical Standards and Quality, Centers for Medicare & Medicaid Services. [FR Doc. E7–12046 Filed 6–21–07; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2000D–0084] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; 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 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. Fax written comments on the collection of information by July 23, 2007. DATES: 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: 202–395–6974. All comments should be identified with the OMB control number 0910–0470. Also include the FDA docket number found in brackets in the heading of this document. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,301–827– 1482. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: Guidance for Industry on Special Protocol Assessment (OMB Control Number 0910–0470)—Extension In the Federal Registerof July 31, 2006 (71 FR 43199), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section No. of Respondents Notification for Carcinogenicity Protocols Annual Frequency per Response Total Annual Responses Hours per Response 21 2.19 46 8 368 151 Requests for Special Protocol Assessment 2.48 374 15 5,610 Total rwilkins on PROD1PC63 with NOTICES 1There Total Hours 5,978 are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Aug<31>2005 16:51 Jun 21, 2007 Jkt 211001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4703 E:\FR\FM\22JNN1.SGM 22JNN1 34471 Federal Register / Vol. 72, No. 120 / Friday, June 22, 2007 / Notices Dated: June 15, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–12056 Filed 6–21–07; 8:45 am] Dated: June 15, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7–12057 Filed 6–21–07; 8:45 am] BILLING CODE 4160–01–S BILLING CODE 4160–01–S documents submitted to OMB may be obtained from Ms. Deitzer or from HUD’s Web site at https:// www5.hud.gov:63001/po/i/icbts/ collectionsearch.cfm. This notice informs the public that the Department of Housing and Urban Development has submitted to OMB a request for approval of the information collection described below. This notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. This notice also lists the following information: Title of Proposal: Housing Choice Voucher Program. OMB Approval Number: 2577–0169. Form Numbers: HUD–52515, HUD– 52517, HUD–52580, HUD–52646, HUD– 52665, HUD–52667, HUD–52672, HUD– 52681, HUD–52681–B, HUD–52641, HUD–52641–A, HUD–52642, HUD– 52642–A, and HUD–52649. Description of the Need for the Information and Its Proposed Use: Public Housing Authorities (PHAs) apply for funding to assist very-lowincome families to lease or purchase housing. PHAs maintain records on participant eligibility, unit acceptability, lease and/or housing assistance payments, and budget and payment documentation. Frequency of Submission: On Occasion, Quarterly, Annually. SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT Food and Drug Administration [Docket No. FR–5117–N–52] [Docket No. 2006N–0528] Notice of Submission of Proposed Information Collection to OMB; Housing Choice Voucher Program Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Infant Formula Requirements AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Infant Formula Requirements’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief Information Officer (HFA–250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857,301–827– 4659. In the Federal Register of March 26, 2007 (72 FR 14116), 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 0910–0256. The approval expires on June 30, 2010. A copy of the supporting statement for this information collection is available on the Internet at https://www.fda.gov/ ohrms/dockets. SUPPLEMENTARY INFORMATION: Office of the Chief Information Officer, HUD. ACTION: Notice. AGENCY: SUMMARY: The proposed information collection requirement described below has been submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. Public Housing Authorities (PHAs) apply for funding to assist very-lowincome families to lease or purchase housing. PHAs maintain records on participant eligibility, unit acceptability, lease and/or housing assistance payments, and budget and payment documentation. DATES: Comments Due Date: July 23, 2007. ADDRESSES: Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB approval Number (2577–0169) and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202–395–6974. FOR FURTHER INFORMATION CONTACT: Lillian Deitzer, Departmental Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 Seventh Street, SW, Washington, DC 20410; e-mail Lillian_L._Deitzer@HUD.gov or telephone (202) 708–2374. This is not a toll-free number. Copies of available Number of respondents Annual responses 492,450 6.11 rwilkins on PROD1PC63 with NOTICES Reporting Burden .............................................................................. VerDate Aug<31>2005 16:51 Jun 21, 2007 Jkt 211001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 E:\FR\FM\22JNN1.SGM × Hours per response .355 22JNN1 = Burden hours 1,072,975

Agencies

[Federal Register Volume 72, Number 120 (Friday, June 22, 2007)]
[Notices]
[Pages 34470-34471]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-12056]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2000D-0084]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; 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 
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 July 
23, 2007.

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: 202-395-6974. All comments should be identified with the OMB 
control number 0910-0470. Also include the FDA docket number found in 
brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of the 
Chief Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857,301-827-1482.

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.

Guidance for Industry on Special Protocol Assessment (OMB Control 
Number 0910-0470)--Extension

    In the Federal Registerof July 31, 2006 (71 FR 43199), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                           Annual Frequency per     Total Annual        Hours per
                   21 CFR Section                     No. of  Respondents        Response            Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification for Carcinogenicity Protocols                             21                  2.19                 46                  8                368
--------------------------------------------------------------------------------------------------------------------------------------------------------
Requests for Special Protocol Assessment                              151                  2.48                374                 15              5,610
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                ....................  ....................  .................  .................              5,978
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.



[[Page 34471]]

    Dated: June 15, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-12056 Filed 6-21-07; 8:45 am]
BILLING CODE 4160-01-S
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