Agency Information Collection Activities: Proposed Collection; Comment Request, 51820-51821 [E8-20686]

Download as PDF 51820 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices promote sustainable growth in output. To further its long–run objectives, the Committee in the immediate future seeks conditions in reserve markets consistent with maintaining the federal funds rate at an average of around 2 percent. By order of the Federal Open Market Committee, August 26, 2008. Brian F. Madigan, Secretary, Federal Open Market Committee. [FR Doc. E8–20558 Field 9–4–08; 8:45 am] BILLING CODE 6210–01–S FEDERAL TRADE COMMISSION SES Performance Review Board AGENCY: ACTION: Federal Trade Commission Notice SUMMARY: Notice is hereby given of the appointment of members to the Federal Trade Commission’s Performance Review Board. FOR FURTHER INFORMATION CONTACT: Karen Leydon, Director of Human Resources, 600 Pennsylvania Avenue NW, Washington, DC 20580, (202) 3262633. SUPPLEMENTARY INFORMATION: Publication of the Performance Review Board (PRB) membership is required by 5 U.S.C. 4314 (c)(4). The PRB reviews and evaluates the initial appraisal of a senior executive’s performance by the supervisor, and makes recommendations regarding performance ratings, performance awards, and pay-for-performance pay adjustments to the FTC Chairman. The following individuals have been designated to serve on the FTC’s Performance Review Board: Charles H. Schneider, Chairman William Blumenthal Pauline M. Ippolito Lydia B. Parnes David P. Wales By direction of the Commission. mstockstill on PROD1PC66 with NOTICES Donald S. Clark Secretary [FR Doc. E8–20571 Filed 9–4–08: 8:45 am] BILLING CODE 6750–01–S VerDate Aug<31>2005 18:40 Sep 04, 2008 Jkt 214001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS–10151 and CMS– 10152] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS) is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Data Collection for Medicare Beneficiaries Receiving Implantable Cardioverter-defibrillator for Primary Prevention of Sudden Cardiac Death; Use: The Centers for Medicare and Medicaid Services (CMS) provides coverage for implantable cardioverter-defibrillators (ICDs) for secondary prevention of sudden cardiac death based on extensive evidence showing that use of ICDs among patients with a certain set of physiologic conditions are effective. Accordingly, CMS considers coverage for ICDs reasonable and necessary under Section 1862 (a)(1)(A) of the Social Security Act. However, evidence for use of ICDs for primary prevention of sudden cardiac death is less compelling for certain patients. To encourage responsible and appropriate use of ICDs, CMS issued a Decision Memo for Implantable Defibrillators on January 27, 2005, indicating that ICDs will be covered for primary prevention of sudden cardiac death if the beneficiary is enrolled in either an FDA-approved category B IDE clinical trial (42 CFR 405.201), a trial AGENCY: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 under the CMS Clinical Trial Policy (NCD Manual § 310.1) or a qualifying prospective data collection system (either a practical clinical trial or prospective systematic data collection, which is sometimes referred to as a registry). Form Number: CMS–10151 (OMB# 0938–0967); Frequency: Reporting—Quarterly; Affected Public: Business or other for-profit and not-forprofit institutions; Number of Respondents: 1,217; Total Annual Responses: 50,000; Total Annual Hours: 12,500. 2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Data collection for Medicare Beneficiaries Receiving FDG Positron Emission Tomography (PET) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and All Other Cancers Use: In the Decision Memo #CAG–00181N issued on January 27, 2005, CMS determined that the evidence is sufficient to conclude that for Medicare beneficiaries receiving FDG positron emission tomography (PET) for brain, cervical, ovarian, pancreatic, small cell lung, and testicular cancers is reasonable and necessary only when the provider is participating in and patients are enrolled in a systematic data collection project. CMS will consider prospective data collection systems to be qualified if they provide assurance that specific hypotheses are addressed and they collect appropriate data elements. The data collection should include baseline patient characteristics; indications for the PET scan; PET scan type and characteristics; FDG PET results; results of all other imaging studies; facility and provider characteristics; cancer type, grade, and stage; long-term patient outcomes; disease management changes; and anti-cancer treatment received. Form Number: CMS–10152 (OMB# 0938–0968); Frequency: Reporting—On occasion; Affected Public: Business or other for-profit and not-for-profit institutions; Number of Respondents: 2,000; Total Annual Responses: 50,000; Total Annual Hours: 4,167. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS’ Web Site at https://www.cms.hhs.gov/ PaperworkReductionActof1995, or Email your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Reports Clearance Office on (410) 786– 1326. In commenting on the proposed information collections please reference E:\FR\FM\05SEN1.SGM 05SEN1 Federal Register / Vol. 73, No. 173 / Friday, September 5, 2008 / Notices the document identifier or OMB control number. To be assured consideration, comments and recommendations must be submitted in one of the following ways by November 4, 2008: 1. Electronically. You may submit your comments electronically to https:// www.regulations.gov. Follow the instructions for ‘‘Comment or Submission’’ or ‘‘More Search Options’’ to find the information collection document(s) accepting comments. 2. By regular mail. You may mail written comments to the following address: CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development, Attention: Document Identifier/OMB Control Number lllll, Room C4–26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. Dated: August 29, 2008. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E8–20686 Filed 9–4–08; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0312] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Extralabel Drug Use in Animals 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 October 6, 2008. 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, or e-mailed to baguilar@omb.eop.gov. All comments should be identified with the OMB control number 0910–0325. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Denver Presley, Jr., Office of Information Management (HFA–710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–796–3793. 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. Extralabel Drug Use in Animals—21 CFR part 530 (OMB Control Number 0910–0325)—Extension Under part 530 (21 CFR Part 530), a veterinarian is permitted to prescribe the extralabel use of approved new animal drugs. Section 530.22 (b) of the implementing regulations permits FDA, if it finds there is a reasonable 51821 probability that the extralabel use of an animal drug may present a risk to the public health, to: (1) Establish a safe level for a residue from the extralabel use of the drug, and (2) require the development of an analytical method for the detection of residues above that established safe level. To date, FDA has not established a safe level for a residue from the extralabel use of any new animal drug and therefore has not required the development of analytical methodology. However, the agency believes that there may be instances when analytical methodology will be required. Thus, FDA is estimating the reporting burden based on two methods being required annually. The requirement to establish an analytical method may be fulfilled by any interested person. The agency believes that the sponsor of the drug will be willing to develop the method in most cases. Alternatively, FDA, the sponsor, and perhaps a third party may cooperatively arrange for method development. The respondents may be sponsors of new animal drugs, State, or Federal government, or individuals. In the Federal Register of June 3, 2008 (73 FR 31693), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 21 CFR Section No. of Respondents 530.22(b) mstockstill on PROD1PC66 with NOTICES 1 There Annual Frequency per Response 2 Total Annual Responses 1 Hours per Response 2 4,160 are no capital costs or operating and maintenance costs associated with this collection of information. VerDate Aug<31>2005 18:40 Sep 04, 2008 Jkt 214001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\05SEN1.SGM 05SEN1 Total Hours 8,320

Agencies

[Federal Register Volume 73, Number 173 (Friday, September 5, 2008)]
[Notices]
[Pages 51820-51821]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-20686]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-10151 and CMS-10152]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services.

    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid 
Services (CMS) is publishing the following summary of proposed 
collections for public comment. Interested persons are invited to send 
comments regarding this burden estimate or any other aspect of this 
collection of information, including any of the following subjects: (1) 
The necessity and utility of the proposed information collection for 
the proper performance of the agency's functions; (2) the accuracy of 
the estimated burden; (3) ways to enhance the quality, utility, and 
clarity of the information to be collected; and (4) the use of 
automated collection techniques or other forms of information 
technology to minimize the information collection burden.
    1. Type of Information Collection Request: Revision of a currently 
approved collection; Title of Information Collection: Data Collection 
for Medicare Beneficiaries Receiving Implantable Cardioverter-
defibrillator for Primary Prevention of Sudden Cardiac Death; Use: The 
Centers for Medicare and Medicaid Services (CMS) provides coverage for 
implantable cardioverter-defibrillators (ICDs) for secondary prevention 
of sudden cardiac death based on extensive evidence showing that use of 
ICDs among patients with a certain set of physiologic conditions are 
effective. Accordingly, CMS considers coverage for ICDs reasonable and 
necessary under Section 1862 (a)(1)(A) of the Social Security Act. 
However, evidence for use of ICDs for primary prevention of sudden 
cardiac death is less compelling for certain patients.
    To encourage responsible and appropriate use of ICDs, CMS issued a 
Decision Memo for Implantable Defibrillators on January 27, 2005, 
indicating that ICDs will be covered for primary prevention of sudden 
cardiac death if the beneficiary is enrolled in either an FDA-approved 
category B IDE clinical trial (42 CFR 405.201), a trial under the CMS 
Clinical Trial Policy (NCD Manual Sec.  310.1) or a qualifying 
prospective data collection system (either a practical clinical trial 
or prospective systematic data collection, which is sometimes referred 
to as a registry). Form Number: CMS-10151 (OMB 0938-0967); 
Frequency: Reporting--Quarterly; Affected Public: Business or other 
for-profit and not-for-profit institutions; Number of Respondents: 
1,217; Total Annual Responses: 50,000; Total Annual Hours: 12,500.
    2. Type of Information Collection Request: Extension of a currently 
approved collection; Title of Information Collection: Data collection 
for Medicare Beneficiaries Receiving FDG Positron Emission Tomography 
(PET) for Brain, Cervical, Ovarian, Pancreatic, Small Cell Lung, and 
All Other Cancers Use: In the Decision Memo CAG-00181N issued 
on January 27, 2005, CMS determined that the evidence is sufficient to 
conclude that for Medicare beneficiaries receiving FDG positron 
emission tomography (PET) for brain, cervical, ovarian, pancreatic, 
small cell lung, and testicular cancers is reasonable and necessary 
only when the provider is participating in and patients are enrolled in 
a systematic data collection project. CMS will consider prospective 
data collection systems to be qualified if they provide assurance that 
specific hypotheses are addressed and they collect appropriate data 
elements. The data collection should include baseline patient 
characteristics; indications for the PET scan; PET scan type and 
characteristics; FDG PET results; results of all other imaging studies; 
facility and provider characteristics; cancer type, grade, and stage; 
long-term patient outcomes; disease management changes; and anti-cancer 
treatment received. Form Number: CMS-10152 (OMB 0938-0968); 
Frequency: Reporting--On occasion; Affected Public: Business or other 
for-profit and not-for-profit institutions; Number of Respondents: 
2,000; Total Annual Responses: 50,000; Total Annual Hours: 4,167.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS' 
Web Site at https://www.cms.hhs.gov/PaperworkReductionActof1995, or E-
mail your request, including your address, phone number, OMB number, 
and CMS document identifier, to Paperwork@cms.hhs.gov, or call the 
Reports Clearance Office on (410) 786-1326.
    In commenting on the proposed information collections please 
reference

[[Page 51821]]

the document identifier or OMB control number. To be assured 
consideration, comments and recommendations must be submitted in one of 
the following ways by November 4, 2008:
    1. Electronically. You may submit your comments electronically to 
https://www.regulations.gov. Follow the instructions for ``Comment or 
Submission'' or ``More Search Options'' to find the information 
collection document(s) accepting comments.
    2. By regular mail. You may mail written comments to the following 
address:
CMS, Office of Strategic Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB Control Number ----------,
Room C4-26-05,
7500 Security Boulevard,
Baltimore, Maryland 21244-1850.

    Dated: August 29, 2008.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. E8-20686 Filed 9-4-08; 8:45 am]
BILLING CODE 4120-01-P

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