59772 Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Notices 

Management and Budget, Attention: 

Desk Officer for the Federal Trade 

Commission, New Executive Office 

Building, Docket Library, Room 10102, 

725 17th Street NW., Washington, DC 

20503. Comments sent to OMB by U.S. 

postal mail, however, are subject to 

delays due to heightened security 

precautions. Thus, comments instead 

should be sent by facsimile to (202) 

395–5806. 

David C. Shonka, 

Principal Deputy General Counsel. 

[FR Doc. 2014–23601 Filed 10–2–14; 8:45 am] 

BILLING CODE 6750–01–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 

Wednesday, October 29, 2014, from 8:30 

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

October 30, 2014, from 8:30 a.m. until 

4:00 p.m. 

ADDRESSES: Fishers Lane Conference 

Center, Terrace Level, 5635 Fishers 

Lane, Rockville, Maryland 20852. 

FOR FURTHER 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 and 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., Wednesday, October 29. 

Following opening remarks from Dr. 

Jerry Menikoff, Executive Secretary of 

SACHRP and OHRP Director, and Dr. 

Jeffrey Botkin, SACHRP Chair, new 

members will be introduced. The 

Subpart A Subcommittee (SAS) will 

then give their report on the new SAS 

initiative examining informed consent. 

SAS 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. SAS was 

established by SACHRP in October 

2006. Following this report, an OHRP 

staff member will present and discuss 

OHRP data addressing incidental 

findings and corrective action plans. 

On October 30, the Subcommittee on 

Harmonization (SOH) will discuss their 

work on the topic of the intersection of 

the HHS and FDA regulations and ‘‘big 

data’’; this will be followed by a 

presentation of SOH work on the topic 

of return of general results. SOH was 

established by SACHRP at its July 2009 

meeting. SOH is 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. 

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 the 

SACHRP 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: September 29, 2014. 

Jerry Menikoff, 

Executive Secretary, Secretary’s Advisory 

Committee on Human Research Protections, 

Director, Office for Human Research 

Protections. 

[FR Doc. 2014–23664 Filed 10–2–14; 8:45 am] 

BILLING CODE 4150–36–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10538] 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services. 

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 

minimize the information collection 

burden. 

DATES: Comments must be received by 

December 2, 2014: 

ADDRESSES: When commenting, please 

reference the document identifier or 

OMB control number (OCN). 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 lll, Room C4–26– 

05, 7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

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Federal Register / Vol. 79, No. 192 / Friday, October 3, 2014 / Notices 59773 

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/Paperwork

ReductionActof1995. 

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–10538 Prior Authorization Form 

for Beneficiaries Enrolled in Hospice 

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: New collection (Request for a 

new OMB control number); Title of 

Information Collection: Prior 

Authorization Form for Beneficiaries 

Enrolled in Hospice; Use: The form 

would be completed by the prescriber or 

the beneficiary’s hospice, or if the 

prescriber or hospice provides the 

information verbally to the Part D 

sponsor, the form would be completed 

by the sponsor. Information provided on 

the form would be used by the Part D 

sponsor to establish coverage of the drug 

under Medicare Part D. Per statute, 

drugs that are necessary for the 

palliation and management of the 

terminal illness and related conditions 

are not eligible for payment under Part 

D. The standard form provides a vehicle 

for the hospice provider, prescriber or 

sponsor to document that the drug 

prescribed is ‘‘unrelated’’ to the 

terminal illness and related conditions. 

It also gives a hospice organization the 

option to communicate a beneficiary’s 

change in hospice status and care plan 

to Part D sponsors. Form Number: CMS– 

10538 (OMB control number 0938-New; 

Frequency: Occasionally; Affected 

Public: Private sector (business or other 

for-profits); Number of Respondents: 

424; Total Annual Responses: 376,487; 

Total Annual Hours: 31,374. (For policy 

questions regarding this collection 

contact Shelly Winston at 410–786– 

3694). 

Dated: September 30, 2014. 

Martique Jones, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2014–23613 Filed 10–2–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10237, CMS– 

10357 and CMS–10499] 

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 November 3, 2014. 

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 

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: Under the 

Paperwork Reduction Act of 1995 (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 (44 U.S.C. 

3506(c)(2)(A)) requires federal agencies 

to publish a 30-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 that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Part C— 

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