Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB), 57178-57179 [E9-26541]

Download as PDF 57178 Federal Register / Vol. 74, No. 212 / Wednesday, November 4, 2009 / Notices contractors must undergo a minimum of a FBI National Criminal Information Check (NCIC) to receive unescorted physical access. Temporary contractors’ Social Security Number is needed to keep records accurate, because other people may have the same name and birth date. Executive Order 9397 Numbering System for Federal Accounts Relating to Individual Persons also allows Federal agencies to use this number to help identify individuals in agency records. GSA describes how information will be maintained in the Privacy Act system of record notice published in the Federal Register at 73 FR 35690 on June 24, 2008. B. Annual Reporting Burden Respondents: 24,480. Responses per Respondent: 1. Hours per Response: .25. Total Burden Hours: 6,120. Obtaining Copies of Proposals: Requesters may obtain a copy of the information collection documents from the General Services Administration, Regulatory Secretariat (MVPR), 1800 F Street, NW., Room 4041, Washington, DC 20405, telephone (202) 501–4755. Please cite OMB Control No. 3090–0283, Temporary Contractor Information Worksheet in all correspondence. The form can be downloaded from the GSA Forms Library at http://www.gsa.gov/ forms. Type GSA850 in the form search field. Dated: October 29, 2009. Casey Coleman, Chief Information Officer, U.S. General Services Administration. [FR Doc. E9–26469 Filed 11–3–09; 8:45 am] BILLING CODE 6820–34–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services [Document Identifier: CMS–10302] mstockstill on DSKH9S0YB1PROD with NOTICES Emergency Clearance: Public Information Collection Requirements Submitted to the Office of Management and Budget (OMB) AGENCY: Center for Medicare and Medicaid Services. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare and Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send VerDate Nov<24>2008 16:29 Nov 03, 2009 Jkt 220001 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. We are, however, requesting an emergency review of the information collection referenced below. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have submitted to the Office of Management and Budget (OMB) the following requirements for emergency review. We are requesting an emergency review because the collection of this information is needed before the expiration of the normal time limits under OMB’s regulations at 5 CFR Part 1320(a)(2)(ii). This is necessary to ensure compliance with an initiative of the Administration. We cannot reasonably comply with the normal clearance procedures because use of the normal clearance procedures is reasonably likely to cause a statutory deadline to be missed, stated in 5 CFR 1320.13(a)(2)(iii). The Centers for Medicare and Medicaid Services (CMS) is requesting that an information collection request (ICR) for the Collection Requirements for Compendia for Determination of Medically-accepted Indications for Off-label Uses of Drugs and Biologicals in an Anti-cancer Chemotherapeutic Regimen, be processed under the emergency clearance process. Approval of this package is essential in order to comply with the section 182(b) of MIPPA amended Section 1861(t)(2)(B) of the Social Security Act (42 U.S.C. 1395x(t)(2)(B)). 1. Type of Information Collection Request: New collection; Title of Information Collection: Collection Requirements for Compendia for Determination of Medically-accepted Indications for Off-label Uses of Drugs and Biologicals in an Anti-cancer Chemotherapeutic Regimen Use: Congress enacted the Medicare Improvement of Patients and Providers Act (MIPPA). Section 182(b) of MIPPA amended Section 1861(t)(2)(B) of the Social Security Act (42 U.S.C. 1395x(t)(2)(B)) by adding at the end the following new sentence: ‘On and after January 1, 2010, no compendia may be PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 included on the list of compendia under this subparagraph unless the compendia has a publicly transparent process for evaluating therapies and for identifying potential conflicts of interest.’ We believe that the implementation of this statutory provision that compendia have a ‘‘publicly transparent process for evaluating therapies and for identifying potential conflicts of interests’’ is best accomplished by amending 42 CFR 414.930 to include the MIPPA requirements and by defining the key components of publicly transparent processes for evaluating therapies and for identifying potential conflicts of interests. All currently listed compendia will be required to comply with these provisions, as of January 1, 2010, to remain on the list of recognized compendia. In addition, any compendium that is the subject of a future request for inclusion on the list of recognized compendia will be required to comply with these provisions. No compendium can be on the list if it does not fully meet the standard described in section 1861(t)(2)(B) of the Act, as revised by section 182(b) of the MIPPA. Form Number: CMS–10302 (OMB#: 0938– New); Frequency: Reporting, Recordkeeping and Third-party disclosure; Affected Public: Business and other for-profits and Not-for-profit institutions; Number of Respondents: 845; Total Annual Responses: 900; Total Annual Hours: 5,135. (For policy questions regarding this collection contact Brijet Burton at 410–786–7364. For all other issues call 410–786–1326.) CMS is requesting OMB review and approval of this collection by December 8, 2009, with a 180-day approval period. Written comments and recommendations will be considered from the public if received by the individuals designated below by November 30, 2009. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS’ Web Site address at: http://www.cms.hhs.gov/ regulations/pra 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. Interested persons are invited to send comments regarding the burden or any other aspect of these collections of information requirements. However, as noted above, comments on these information collection and recordkeeping requirements must be mailed and/or faxed to the designees E:\FR\FM\04NON1.SGM 04NON1 Federal Register / Vol. 74, No. 212 / Wednesday, November 4, 2009 / Notices referenced below by November 30, 2009. 1. Electronically. You may submit your comments electronically to http:// 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. 3. By Facsimile or E-mail to OMB. OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395–6974, Email: OIRA_submission@omb.eop.gov. Dated: October 21, 2009. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E9–26541 Filed 11–3–09; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0347] Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment mstockstill on DSKH9S0YB1PROD with NOTICES period. SUMMARY: The Food and Drug Administration (FDA) is extending to January 4, 2010, the comment period for the draft guidance entitled ‘‘Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons’’ that appeared in the Federal Register of August 3, 2009 (74 FR 38437), as corrected on August 21, 2009 (74 FR 42311). In the notice of availability, FDA requested comments by November 2, 2009. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: Submit written or electronic comments by January 4, 2010. ADDRESSES: Submit electronic comments to http://www. VerDate Nov<24>2008 16:29 Nov 03, 2009 Jkt 220001 regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Willette Crawford, Center for Food Safety and Applied Nutrition (HFS– 317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–1111. SUPPLEMENTARY INFORMATION: In the Federal Register of August 3, 2009 (74 FR 38437), as corrected on August 21, 2009 (74 FR 42311), FDA published a notice of availability with a 90-day comment period to request comments on the draft guidance entitled ‘‘Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons’’ (the draft guidance). Comments on the draft guidance will inform FDA’s current thinking for finalization of this level 1 guidance consistent with FDA’s good guidance practices. The agency has received requests for an extension of the comment period for the draft guidance. FDA has considered the requests and is extending the comment period for the draft guidance until January 4, 2010. The agency believes that this extension allows adequate time for interested persons to submit comments without significantly delaying finalization of this level 1 guidance. II. Request for Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES) written or electronic comments on this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: October 30, 2009. David Horowitz, Assistant Commissioner for Policy. [FR Doc. E9–26638 Filed 11–2–09; 11:15 am] PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–D–0346] Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes; Extension of Comment Period AGENCY: Food and Drug Administration, HHS. ACTION: Notice; extension of comment period. I. Background BILLING CODE 4160–01–S 57179 SUMMARY: The Food and Drug Administration (FDA) is extending to January 4, 2010, the comment period for the draft guidance entitled ‘‘Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes’’ that appeared in the Federal Register of August 3, 2009 (74 FR 38438), as corrected on August 21, 2009 (74 FR 42311). In the notice of availability, FDA requested comments by November 2, 2009. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments. DATES: Submit written or electronic comments by January 4, 2010. ADDRESSES: Submit electronic comments to http://www. regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Michelle A. Smith, Center for Food Safety and Applied Nutrition (HFS– 317), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740, 301–436–2024. SUPPLEMENTARY INFORMATION: I. Background In the Federal Register of August 3, 2009 (74 FR 38438), as corrected on August 21, 2009 (74 FR 42311), FDA published a notice of availability with a 90-day comment period to request comments on the draft guidance entitled ‘‘Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes’’ (the draft guidance). Comments on the draft guidance will inform FDA’s current thinking for finalization of this level 1 guidance consistent with FDA’s good guidance practices. The agency has received requests for an extension of the comment period for the draft guidance. FDA has considered the requests and is extending the E:\FR\FM\04NON1.SGM 04NON1

Agencies

[Federal Register Volume 74, Number 212 (Wednesday, November 4, 2009)]
[Notices]
[Pages 57178-57179]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-26541]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare and Medicaid Services

[Document Identifier: CMS-10302]


Emergency Clearance: Public Information Collection Requirements 
Submitted to the Office of Management and Budget (OMB)

AGENCY: Center for Medicare and Medicaid Services.

    In compliance with the requirement of section 3506(c)(2)(A) of the 
Paperwork Reduction Act of 1995, the Centers for Medicare and Medicaid 
Services (CMS), Department of Health and Human Services, 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.
    We are, however, requesting an emergency review of the information 
collection referenced below. In compliance with the requirement of 
section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, we have 
submitted to the Office of Management and Budget (OMB) the following 
requirements for emergency review. We are requesting an emergency 
review because the collection of this information is needed before the 
expiration of the normal time limits under OMB's regulations at 5 CFR 
Part 1320(a)(2)(ii). This is necessary to ensure compliance with an 
initiative of the Administration. We cannot reasonably comply with the 
normal clearance procedures because use of the normal clearance 
procedures is reasonably likely to cause a statutory deadline to be 
missed, stated in 5 CFR 1320.13(a)(2)(iii). The Centers for Medicare 
and Medicaid Services (CMS) is requesting that an information 
collection request (ICR) for the Collection Requirements for Compendia 
for Determination of Medically-accepted Indications for Off-label Uses 
of Drugs and Biologicals in an Anti-cancer Chemotherapeutic Regimen, be 
processed under the emergency clearance process. Approval of this 
package is essential in order to comply with the section 182(b) of 
MIPPA amended Section 1861(t)(2)(B) of the Social Security Act (42 
U.S.C. 1395x(t)(2)(B)).
    1. Type of Information Collection Request: New collection; Title of 
Information Collection: Collection Requirements for Compendia for 
Determination of Medically-accepted Indications for Off-label Uses of 
Drugs and Biologicals in an Anti-cancer Chemotherapeutic Regimen Use: 
Congress enacted the Medicare Improvement of Patients and Providers Act 
(MIPPA). Section 182(b) of MIPPA amended Section 1861(t)(2)(B) of the 
Social Security Act (42 U.S.C. 1395x(t)(2)(B)) by adding at the end the 
following new sentence: `On and after January 1, 2010, no compendia may 
be included on the list of compendia under this subparagraph unless the 
compendia has a publicly transparent process for evaluating therapies 
and for identifying potential conflicts of interest.' We believe that 
the implementation of this statutory provision that compendia have a 
``publicly transparent process for evaluating therapies and for 
identifying potential conflicts of interests'' is best accomplished by 
amending 42 CFR 414.930 to include the MIPPA requirements and by 
defining the key components of publicly transparent processes for 
evaluating therapies and for identifying potential conflicts of 
interests.
    All currently listed compendia will be required to comply with 
these provisions, as of January 1, 2010, to remain on the list of 
recognized compendia. In addition, any compendium that is the subject 
of a future request for inclusion on the list of recognized compendia 
will be required to comply with these provisions. No compendium can be 
on the list if it does not fully meet the standard described in section 
1861(t)(2)(B) of the Act, as revised by section 182(b) of the MIPPA. 
Form Number: CMS-10302 (OMB: 0938-New); Frequency: Reporting, 
Recordkeeping and Third-party disclosure; Affected Public: Business and 
other for-profits and Not-for-profit institutions; Number of 
Respondents: 845; Total Annual Responses: 900; Total Annual Hours: 
5,135. (For policy questions regarding this collection contact Brijet 
Burton at 410-786-7364. For all other issues call 410-786-1326.)
    CMS is requesting OMB review and approval of this collection by 
December 8, 2009, with a 180-day approval period. Written comments and 
recommendations will be considered from the public if received by the 
individuals designated below by November 30, 2009.
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS' 
Web Site address at: http://www.cms.hhs.gov/regulations/pra 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.
    Interested persons are invited to send comments regarding the 
burden or any other aspect of these collections of information 
requirements. However, as noted above, comments on these information 
collection and recordkeeping requirements must be mailed and/or faxed 
to the designees

[[Page 57179]]

referenced below by November 30, 2009.
    1. Electronically. You may submit your comments electronically to 
http://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.
    3. By Facsimile or E-mail to OMB. OMB, Office of Information and 
Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395-
6974, E-mail: OIRA_submission@omb.eop.gov.

    Dated: October 21, 2009.
Michelle Shortt,
Director, Regulations Development Group, Office of Strategic Operations 
and Regulatory Affairs.
[FR Doc. E9-26541 Filed 11-3-09; 8:45 am]
BILLING CODE 4120-01-P