10686 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices 

security of United States citizens living 

abroad and that involves EV–D68. 

III. Declaration of the Secretary of 

Health and Human Services 

Also on February 6, 2015, on the basis 

of my determination of a significant 

potential for a public health emergency 

that has a significant potential to affect 

national security or the health and 

security of United States citizens living 

abroad and that involves EV–D68, I 

declared that circumstances exist 

justifying the authorization of 

emergency use of new in vitro 

diagnostics for detection of EV–D68 

pursuant to section 564 of the FD&C 

Act, subject to the terms of any 

authorization issued under that section. 

Notice of the EUAs issued by the FDA 

Commissioner pursuant to this 

determination and declaration will be 

provided promptly in the Federal 

Register as required under section 564 

of the FD&C Act. 

Dated: February 6, 2015. 

Sylvia M. Burwell, 

Secretary. 

[FR Doc. 2015–04121 Filed 2–26–15; 8:45 am] 

BILLING CODE 4150–37–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Meeting of the Secretary’s Advisory 

Committee on Human Research 

Protections 

AGENCY: Office of the Assistant 

Secretary for Health, Office of the 

Secretary, Department of Health and 

Human Services. 

ACTION: Notice. 

SUMMARY: Pursuant to Section 10(a) of 

the Federal Advisory Committee Act, 

U.S.C. Appendix 2, notice is hereby 

given that the Secretary’s Advisory 

Committee on Human Research 

Protections (SACHRP) will hold a 

meeting that will be open to the public. 

Information about SACHRP and the full 

meeting agenda will be posted on the 

SACHRP Web site at: http://

www.dhhs.gov/ohrp/sachrp/mtgings/

index.html. 

DATES: The meeting will be held on 

Tuesday, March 24, 2015, from 8:30 

a.m. until 5:00 p.m. and Wednesday, 

March 25, 2015, from 8:30 a.m. until 

4:30 p.m. 

ADDRESSES: Fishers Lane Conference 

Center, Terrace Level, 5635 Fishers 

Lane, Rockville, Maryland 20852. 

FOR FUTHER INFORMATION CONTACT: Jerry 

Menikoff, M.D., J.D., Director, Office for 

Human Research Protections (OHRP), or 

Julia Gorey, J.D., Executive Director, 

SACHRP; U.S. Department of Health 

and Human Services, 1101 Wootton 

Parkway, Suite 200, Rockville, 

Maryland 20852; 240–453–8141; fax: 

240–453–6909; email address: 

SACHRP@hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

authority of 42 U.S.C. 217a, Section 222 

of the Public Health Service Act, as 

amended, SACHRP was established to 

provide expert advice and 

recommendations to the Secretary of 

Health and Human Services, through 

the Assistant Secretary for Health, on 

issues and topics pertaining to or 

associated with the protection of human 

research subjects. 

The meeting will open to the public 

at 8:30 a.m., on Tuesday, March 24. 

Following opening remarks from Dr. 

Jerry Menikoff, Executive Secretary of 

SACHRP and OHRP Director, and Dr. 

Jeffrey Botkin, SACHRP Chair, Dr. 

Botkin and invited speakers will discuss 

issues surrounding the use of newborn 

dried bloodspots in research. The 

Subpart A Subcommittee (SAS) report 

will follow; SAS will discuss draft 

recommendations on the research uses 

of newborn dried bloodspots and the 

Newborn Screening Saves Lives 

Reauthorization Act of 2014. SAS was 

established by SACHRP in October 2006 

and is charged with developing 

recommendations for consideration by 

SACHRP regarding the application of 

subpart A of 45 CFR part 46 in the 

current research environment. 

In the afternoon of March 24, the 

Subcommittee on Harmonization (SOH) 

will present their report; SOH was 

established by SACHRP at its July 2009 

meeting and charged with identifying 

and prioritizing areas in which 

regulations and/or guidelines for human 

subjects research adopted by various 

agencies or offices within HHS would 

benefit from harmonization, 

consistency, clarity, simplification and/ 

or coordination. SOH will present 

recommendations on the research use of 

‘‘big data’’ and the intersection of the 

HHS and FDA regulations. 

On March 25, the SOH will discuss 

the return of individual research results 

with special considerations regarding 

HIPAA and CLIA; this will be followed 

by presentation of SOH 

recommendations on the FDA draft 

guidance ‘‘General Clinical 

Pharmacology Considerations for 

Pediatric Studies for Drugs and 

Biologics.’’ The meeting will adjourn at 

4:30 p.m. March 25, 2015. Time for 

public comment sessions will be 

allotted both days. 

Public attendance at the meeting is 

limited to space available. Individuals 

who plan to attend and need special 

assistance, such as sign language 

interpretation or other reasonable 

accommodations, should notify one of 

the designated SACHRP points of 

contact at the address/phone number 

listed above at least one week prior to 

the meeting. Pre-registration is required 

for participation in the on-site public 

comment session; individuals may preregister the day of the meeting. 

Individuals who would like to submit 

written statements should email or fax 

their comments to SACHRP at 

SACHRP@hhs.gov at least five business 

days prior to the meeting. 

Dated: February 23, 2015. 

Jerry Menikoff, 

Executive Secretary, Secretary’s Advisory 

Committee on Human Research Protections, 

Director, Office for Human Research 

Protections. 

[FR Doc. 2015–04120 Filed 2–26–15; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–1696 and CMS– 

10417] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information (including each proposed 

extension or reinstatement of an existing 

collection of information) and to allow 

60 days for public comment on the 

proposed action. Interested persons are 

invited to send comments regarding our 

burden estimates 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 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Notices 10687 

minimize the information collection 

burden. 

DATES: Comments must be received by 

April 28, 2015. 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number. To be assured 

consideration, comments and 

recommendations must be submitted in 

any one of the following ways: 

1. Electronically. You may send 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) that are 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. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ Web site address at 

http://www.cms.hhs.gov/

PaperworkReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

Reports Clearance Office at (410) 786– 

1326. 

SUPPLEMENTARY INFORMATION: 

Contents 

This notice sets out a summary of the 

use and burden associated with the 

following information collections. More 

detailed information can be found in 

each collection’s supporting statement 

and associated materials (see 

ADDRESSES). 

CMS–1696 Appointment of 

Representative 

Under the PRA (44 U.S.C. 3501– 

3520), federal agencies must obtain 

approval from the Office of Management 

and Budget (OMB) for each collection of 

information they conduct or sponsor. 

The term ‘‘collection of information’’ is 

defined in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA 

requires federal agencies to publish a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, before 

submitting the collection to OMB for 

approval. To comply with this 

requirement, CMS is publishing this 

notice. 

Information Collection 

1. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Appointment of 

Representative; Use: The Appointment 

of Representative form is completed by 

beneficiaries, providers and suppliers, 

and any party seeking to appoint a 

representative to assist them with their 

initial determinations and filing 

appeals. This extension request 

proposes non-substantive changes to the 

form. Form Number: CMS–1696 (OMB 

control number 0938–0950); Frequency: 

Once; Affected Public: Individuals and 

households and the Private sector 

(Business or other for-profits); Number 

of Respondents: 4,073,960; Total 

Annual Responses: 407,396; Total 

Annual Hours: 101,849. (For policy 

questions regarding this collection 

contact Katherine Hosna at 410–786– 

4993). 

2. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Medicare Feefor-Service Prepayment Medical 

Review; Use: The information required 

under this collection is requested by 

Medicare contractors to determine 

proper payment or if there is a suspicion 

of fraud. Medicare contractors request 

the information from providers or 

suppliers submitting claims for payment 

from the Medicare program when data 

analysis indicates aberrant billing 

patterns or other information which 

may present a vulnerability to the 

Medicare program. Form Number: 

CMS–10417 (OMB control number: 

0938–0969); Frequency: Occasionally; 

Affected Public: Private Sector (Business 

or other for-profit and Not-for-profit 

institutions); Number of Respondents: 

3,211,800; Total Annual Responses: 

3,211,800; Total Annual Hours: 

1,597,950. (For policy questions 

regarding this collection contact Debbie 

Skinner at 410–786–7480.) 

Dated: February 24, 2015. 

William N. Parham, III 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2015–04115 Filed 2–26–15; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier CMS–10341 and CMS– 

10522] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. Under the 

Paperwork Reduction Act of 1995 

(PRA), federal agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the 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. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by March 30, 2015. 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–5806 or Email: 

OIRA_submission@omb.eop.gov. 

To obtain copies of a supporting 

statement and any related forms for the 

mstockstill on DSK4VPTVN1PROD with NOTICES