Federal Register / Vol. 77, No. 185 / Monday, September 24, 2012 / Notices 58847 

ESTIMATED ANNUALIZED BURDEN HOURS—Continued 

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(hours) 

Total burden 

(hours) 

Phase II Mine Safety Personnel ....... Fatigue Risk Management Systems 

Assessment Tool.

50 1 1 50 

Phase II Miners ................................. Focus Groups ................................... 30 1 1 30 

Phase III Miners ................................ Experimental Research Studies ....... 20 1 1 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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Committee to the Director 

(ACD), Centers for Disease Control and 

Prevention (CDC) 

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. 

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 14, 2012. 

Elaine L. Baker, 

Director, Management Analysis and Services 

Office, Centers for Disease Control and 

Prevention. 

[FR Doc. 2012–23455 Filed 9–21–12; 8:45 am] 

BILLING CODE 4163–18–P 

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) 

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: 

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 

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. 

[FR Doc. 2012–23452 Filed 9–21–12; 8:45 am] 

BILLING CODE 4163–18–P 

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 


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 http://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 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 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. 

ACTION: Notice of meetings; request for 

notification of participation. 

SUMMARY: 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 

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 http:// 

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 

http://www.fda.gov/downloads/ 

ForIndustry/UserFees/ 

PrescriptionDrugUserFee/ 

UCM270412.pdf. 

Section X of these commitments 

relates to enhancing benefit-risk 

assessments in regulatory 


TKELLEY on DSK3SPTVN1PROD with NOTICES