Agency Information Collection Activities: Proposed Collection; Comment Request, 58847-58848 [2012-23367]

Download as PDF 58847 Federal Register / Vol. 77, No. 185 / Monday, September 24, 2012 / Notices ESTIMATED ANNUALIZED BURDEN HOURS—Continued Number of responses per respondent Number of respondents Average burden per response (hours) Total burden (hours) Type of respondents Form name Phase II Mine Safety Personnel ....... 50 1 1 50 Phase II Miners ................................. Phase III Miners ................................ Fatigue Risk Management Systems Assessment Tool. Focus Groups ................................... Experimental Research Studies ....... 30 20 1 1 1 1 30 20 Total ........................................... ........................................................... ........................ ........................ ........................ 295 Dated: September 14, 2012. Ron A. Otten, Director, Office of Scientific Integrity, Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. [FR Doc. 2012–23191 Filed 9–21–12; 8:45 am] BILLING CODE 4163–18–P Dated: September 14, 2012. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. DEPARTMENT OF HEALTH AND HUMAN SERVICES [FR Doc. 2012–23455 Filed 9–21–12; 8:45 am] Centers for Disease Control and Prevention BILLING CODE 4163–18–P Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC) TKELLEY on DSK3SPTVN1PROD with NOTICES In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the CDC announces the following meeting of the aforementioned committee: Time and Date: 2 p.m.–4 p.m. (EDT), Thursday, October 25, 2012. Place: Teleconference. Status: Open to the public, limited only by the availability of telephone ports. The public is welcome to participate during the public comment period. The public comment period is tentatively scheduled for 3:50 p.m.– 3:55 p.m. To participate in the teleconference, please dial (877) 930–8819 and enter code 1579739. Purpose: The committee will provide advice to the CDC Director on policy and broad strategies that will enable CDC to fulfill its mission of protecting health through health promotion, prevention, and preparedness. Matters To Be Discussed: Agenda items will include the following updates from the Global Workgroup; updates from the State, Tribal, Local and Territorial Workgroup; and Ethics Subcommittee, as well as an update from the CDC Director. The agenda is subject to change as priorities dictate. Contact Person for More Information: Carmen Villar, MSW, Designated Federal Officer, ACD, CDC, 1600 Clifton Road NE., M/S D–14, Atlanta, Georgia 30333, telephone (404) 639–7000, email: GHickman@cdc.gov. The deadline for notification of attendance is October 19, 2012. To register for this meeting, please send an email to ACDirector@cdc.gov. VerDate Mar<15>2010 18:54 Sep 21, 2012 Jkt 226001 The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Board of Scientific Counselors, National Center for Injury Prevention and Control (BSC, NCIPC) partnerships; Science Update; health communication; global activities; Research to Practice Agenda; and increasing programmatic input to the BSC. There will be 15 minutes allotted for public comments at the end of the open session. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Gwendolyn H. Cattledge, Ph.D., M.S.E.H., Deputy Associate Director for Science, NCIPC, CDC, 4770 Buford Highway, NE., Mailstop F–63, Atlanta, Georgia 30341, Telephone (770) 488–1430. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities, for both the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. Dated: September 17, 2012. Elaine L. Baker, Director, Management Analysis and Services Office, Centers for Disease Control and Prevention. In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L.92–463), the Centers for Disease Control and Prevention (CDC) announces the following meeting of the aforementioned board: [FR Doc. 2012–23452 Filed 9–21–12; 8:45 am] Times and Dates 8:30 a.m.–4:30 p.m., October 18, 2012. 8:30 a.m.–2 p.m., October 19, 2012. Place: Centers for Disease Control and Prevention, 4770 Buford Highway, NE., Building 106, Atlanta, Georgia 30341. Status: Open to the public, limited only by the space available. Purpose: The Board will: (1) Conduct, encourage, cooperate with, and assist other appropriate public health authorities, scientific institutions, and scientists in the conduct of research, investigations, experiments, demonstrations, and studies relating to the causes, diagnosis, treatment, control, and prevention of physical and mental diseases, and other impairments and (2) conduct and assist in research and control activities related to injury. Matters To Be Discussed: The BSC, NCIPC will discuss the strategies and activities needed to guide the Center’s research and program focus. Topics to be discussed include the Director’s Update on the budget appropriation, reorganization and Centers for Medicare & Medicaid Services PO 00000 Frm 00046 Fmt 4703 Sfmt 4703 BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: CMS–846–849, 10125 and 10126] Agency Information Collection Activities: Proposed Collection; Comment Request Centers for Medicare & Medicaid Services, HHS. 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 AGENCY: E:\FR\FM\24SEN1.SGM 24SEN1 TKELLEY on DSK3SPTVN1PROD with NOTICES 58848 Federal Register / Vol. 77, No. 185 / Monday, September 24, 2012 / Notices 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: Extension of a currently approved collection; Title: Durable Medical Equipment Medicare Administrative Contractor Certificate of Medical Necessity and Supporting Documentation Requirements; Use: The certificates of medical necessity (CMNs) collect information required to help determine the medical necessity of certain items. CMS requires CMNs where there may be a vulnerability to the Medicare program. Each initial claim for these items must have an associated CMN for the beneficiary. Suppliers (those who bill for the items) complete the administrative information (e.g., patient’s name and address, items ordered, etc.) on each CMN. The 1994 Amendments to the Social Security Act require that the supplier also provide a narrative description of the items ordered and all related accessories, their charge for each of these items, and the Medicare fee schedule allowance (where applicable). The supplier then sends the CMN to the treating physician or other clinicians (e.g., physician assistant, LPN, etc.) who completes questions pertaining to the beneficiary’s medical condition and signs the CMN. The physician or other clinician returns the CMN to the supplier who has the option to maintain a copy and then submits the CMN (paper or electronic) to CMS, along with a claim for reimbursement. This clearance request is for CMNs with the form numbers, CMS 846–849, 10125 and 10126. Form Numbers: CMS–846, 847, 848, 849, 10125, 10126 (OCN: 0938–0679); Frequency: Occasionally; Affected Public: Individuals or Households; Number of Respondents: 462,000; Total Annual Responses: 462,000; Total Annual Hours: 92,400. (For policy questions regarding this collection contact Doris Jackson at 410– 786–4459. For all other issues call 410– 786–1326.) To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS’ Web Site address at https://www.cms.hhs.gov/ PaperworkReductionActof1995, or Email your request, including your address, phone number, OMB number, VerDate Mar<15>2010 18:54 Sep 21, 2012 Jkt 226001 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 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 23, 2012: 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 llll , Room C4– 26–05, 7500 Security Boulevard, Baltimore, Maryland 21244–1850. Dated: September 18, 2012. Martique Jones, Director, Regulations Development Group, Division B, Office of Strategic Operations and Regulatory Affairs. [FR Doc. 2012–23367 Filed 9–21–12; 8:45 am] BILLING CODE 4120–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0966] Prescription Drug User Fee Act V Patient-Focused Drug Development; Consultation Meetings; Request for Notification of Patient Stakeholder Intention To Participate AGENCY: Food and Drug Administration, HHS. Notice of meetings; request for notification of participation. ACTION: The Food and Drug Administration (FDA) is issuing this notice to request that patient stakeholders notify FDA of their intention to participate in periodic consultation meetings on process issues related to FDA’s patient-focused drug development initiative. This initiative is being conducted to fulfill FDA performance commitments made as part of the fifth authorization of the Prescription Drug User Fee Act (PDUFA V). These periodic consultation meetings will address important considerations and challenges in establishing a process for conducting a SUMMARY: PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 series of patient-focused drug development meetings that will be useful to both the patient community and FDA. The purpose of this request for notification is to ensure continuity and progress in these discussions by establishing consistent patient stakeholder representation. DATES: Submit notification of intention to participate in this series of meetings by October 3, 2012. The first stakeholder meeting on process issues will be held on October 10, 2012, from 2 p.m. to 3:30 p.m. These discussions will continue on an approximately bimonthly basis as needed during PDUFA V. ADDRESSES: Submit notification of intention to participate in this series of meetings by email to PatientFocused@fda.hhs.gov. The first meeting with patient stakeholders will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 51, Rm. 1300, Silver Spring, MD 20993– 0002. Entrance for the consultation meetings’ participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. FOR FURTHER INFORMATION CONTACT: Andrea Tan, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave. Bldg. 51, Rm. 1168, Silver Spring, MD 20993–0002, 301–796–7641, FAX: 301–847–8443, Andrea.Tan@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background On July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA). Title I of FDASIA reauthorizes the Prescription Drug User Fee Act (PDUFA) that provides FDA with the necessary user fee resources to maintain a predictable and efficient review process for human drug and biologic products. The reauthorization of PDUFA includes performance goals and procedures that represent FDA’s commitments during fiscal years 2013– 2017. These commitments are referred to in section 101 of FDASIA and are available on the FDA Web site at https://www.fda.gov/downloads/ ForIndustry/UserFees/ PrescriptionDrugUserFee/ UCM270412.pdf. Section X of these commitments relates to enhancing benefit-risk assessments in regulatory E:\FR\FM\24SEN1.SGM 24SEN1

Agencies

[Federal Register Volume 77, Number 185 (Monday, September 24, 2012)]
[Notices]
[Pages 58847-58848]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-23367]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[Document Identifier: CMS-846-849, 10125 and 10126]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Centers for Medicare & Medicaid Services, HHS.
    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

[[Page 58848]]

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: Extension of a currently 
approved collection;
    Title: Durable Medical Equipment Medicare Administrative Contractor 
Certificate of Medical Necessity and Supporting Documentation 
Requirements; Use: The certificates of medical necessity (CMNs) collect 
information required to help determine the medical necessity of certain 
items. CMS requires CMNs where there may be a vulnerability to the 
Medicare program. Each initial claim for these items must have an 
associated CMN for the beneficiary. Suppliers (those who bill for the 
items) complete the administrative information (e.g., patient's name 
and address, items ordered, etc.) on each CMN. The 1994 Amendments to 
the Social Security Act require that the supplier also provide a 
narrative description of the items ordered and all related accessories, 
their charge for each of these items, and the Medicare fee schedule 
allowance (where applicable). The supplier then sends the CMN to the 
treating physician or other clinicians (e.g., physician assistant, LPN, 
etc.) who completes questions pertaining to the beneficiary's medical 
condition and signs the CMN. The physician or other clinician returns 
the CMN to the supplier who has the option to maintain a copy and then 
submits the CMN (paper or electronic) to CMS, along with a claim for 
reimbursement. This clearance request is for CMNs with the form 
numbers, CMS 846-849, 10125 and 10126. Form Numbers: CMS-846, 847, 848, 
849, 10125, 10126 (OCN: 0938-0679); Frequency: Occasionally; Affected 
Public: Individuals or Households; Number of Respondents: 462,000; 
Total Annual Responses: 462,000; Total Annual Hours: 92,400. (For 
policy questions regarding this collection contact Doris Jackson at 
410-786-4459. For all other issues call 410-786-1326.)
    To obtain copies of the supporting statement and any related forms 
for the proposed paperwork collections referenced above, access CMS' 
Web Site address 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 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 23, 2012:
    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: September 18, 2012.
Martique Jones,
Director, Regulations Development Group, Division B, Office of 
Strategic Operations and Regulatory Affairs.
[FR Doc. 2012-23367 Filed 9-21-12; 8:45 am]
BILLING CODE 4120-01-P

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