11792 Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Notices 

and providing information, to train 

personnel and to be able to respond to 

a collection of information, to search 

data sources, to complete and review 

the collection of information, and to 

transmit or otherwise disclose the 

information. The total annual burden 

hours estimated for this ICR are 

summarized in the table below. 

TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS

Forms (If necessary) Type of respondent Number of 

respondents 

Number of 

responses per 

respondent 

Average burden 

hours per 

response 

(hours) 

Total burden 

hours 

CRM Tool ................................. Regional Extension Center ....... 62 12 1.5 1080 

Total ................................... ................................................... ............................ ............................ ............................ 1080 

Darius Taylor, 

Deputy, Information Collection Clearance 

Officer. 

[FR Doc. 2014–04484 Filed 2–28–14; 8:45 am] 

BILLING CODE 4150–45–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10054] 

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: The 

necessity and utility of the proposed 

information collection for the proper 

performance of the agency’s functions; 

the accuracy of the estimated burden; 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and the use of automated 

collection techniques or other forms of 

information technology to minimize the 

information collection burden. 

DATES: Comments must be received by 

April 29, 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 lllll, 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/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 collection. More 

detailed information can be found in the 

collection’s supporting statement and 

associated materials (see ADDRESSES). 

CMS–10054 Recognition of Payment for 

New Technology Services for New 

Technology Ambulatory Payment 

Classification (APC) Groups Under the 

Outpatient Prospective Payment System 

and Supporting Regulations in 42 CFR 

part 419. 

Under the Paperwork ReductionAct 

(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: Recognition of 

Payment for New Technology Services 

for New Technology Ambulatory 

Payment Classification (APC) Groups 

Under the Outpatient Prospective 

Payment System and Supporting 

Regulations in 42 CFR part 419; Use: 

CMS needs to keep pace with emerging 

new technologies and make them 

accessible to Medicare beneficiaries in a 

timely manner. It is necessary that we 

continue to collect appropriate 

information from interested parties such 

as hospitals, medical device 

manufacturers, pharmaceutical 

companies and others that bring to our 

attention specific services that they 

wish us to evaluate for New Technology 

APC payment. Form Number: CMS– 

10054 (OCN: 0938–0860); Frequency: 

Once; Affected Public: Private sector 

(business or other for-profits); Number 

of Respondents: 10; Total Annual 

Responses: 10; Total Annual Hours: 

160. (For policy questions regarding this 

collection contact Barry Levi at 410– 

786–4529). 

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 79, No. 41 / Monday, March 3, 2014 / Notices 11793 

1Please visit http://www.regulations.gov and 

enter docket number FDA–2008–D–0053. 

2Please visit http://www.regulations.gov and 

enter docket numbers FDA–2011–P–0512 and FDA– 

2013–P–1079. 

Dated: February 26, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–04613 Filed 2–28–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–D–0053] 

Revised Draft Guidance for Industry on 

Distributing Scientific and Medical 

Publications on Unapproved New 

Uses—Recommended Practices; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a revised draft guidance 

for industry entitled ‘‘Distributing 

Scientific and Medical Publications on 

Unapproved New Uses—Recommended 

Practices.’’ This draft guidance revises 

the final guidance titled ‘‘Good Reprint 

Practices for the Distribution of Medical 

Journal Articles and Medical or 

Scientific Reference Publications on 

Unapproved New Uses of Approved 

Drugs and Approved or Cleared Medical 

Devices’’ published in January 2009. 

The revised draft guidance provides 

guidance on FDA’s current thinking on 

recommended practices for drug or 

medical device manufacturers and their 

representatives to follow when 

distributing to health care professionals 

or health care entities scientific or 

medical journal articles, scientific or 

medical reference texts, or clinical 

practice guidelines ((CPGs); all three 

collectively referred to as ‘‘scientific and 

medical publications’’) that discuss 

unapproved new uses for approved 

drugs or approved or cleared medical 

devices marketed in the United States. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comments on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by May 2, 2014. 

Submit either electronic or written 

comments on the proposed collection of 

information by May 2, 2014. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002; to the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, Suite 200N, Rockville, 

MD 20852–1448; or to the Division of 

Small Manufacturers, International and 

Consumer Assistance, Office of 

Communication, Education and 

Radiation Programs, Center for Devices 

and Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4613, Silver Spring, 

MD 20993–0002. Send one selfaddressed adhesive label to assist the 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the draft 

guidance document. 

Submit electronic comments on the 

draft guidance 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: 

Regarding prescription drugs: Bryant 

Godfrey, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave, Bldg. 51, Rm. 3258, Silver Spring, 

MD 20993–0002, 301–796–1200. 

Regarding prescription biological 

products: Stephen Ripley, Center for 

Biologics Evaluation and Research 

(HFM–17), Food and Drug 

Administration, 1401 Rockville Pike, 

Suite 200N, Rockville, MD 20852–1448, 

301–827–6210. 

Regarding medical devices: Deborah 

Wolf, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 3414, Silver Spring, 

MD 20993–0002, 301–796–5732. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a revised draft guidance for industry 

entitled ‘‘Distributing Scientific and 

Medical Publications on Unapproved 

New Uses—Recommended Practices.’’ 

This draft guidance describes 

recommended practices for drug or 

medical device manufacturers or their 

representatives to follow when 

distributing to health care professionals 

or health care entities scientific and 

medical publications that discuss 

unapproved new uses of approved drugs 

or approved or cleared medical devices. 

In January 2009, FDA published a 

final guidance titled ‘‘Good Reprint 

Practices for the Distribution of Medical 

Journal Articles and Medical or 

Scientific Reference Publications on 

Unapproved New Uses of Approved 

Drugs and Approved or Cleared Medical 

Devices,’’ which set forth the Agency’s 

thinking as of that time regarding the 

dissemination by manufacturers of 

medical journal articles and scientific or 

medical reference publications that 

discuss unapproved or uncleared uses 

of medical products.1 FDA received 

comments to the docket for the 2009 

guidance, including submissions 

requesting clarification of how the 

principles set forth in the 2009 guidance 

would apply to medical textbooks and 

potential changes to those principles. 

In July 2011 and September 2013, 

FDA received citizen petitions, filed on 

behalf of multiple prescription drug and 

medical device manufacturers, that 

include several requests related to 

FDA’s approach to the distribution of 

scientific and medical information 

reflecting unapproved or uncleared 

uses, specifically including CPGs.2 FDA 

continues to consider the specific 

requests made in the citizen petitions, 

which include requests for issuance or 

revision of regulations, and has not yet 

reached a final determination on those 

petitions. 

At the same time, FDA continues 

actively to review, analyze, and develop 

approaches to a variety of topics of 

interest to industry and others, 

including issues raised in the petition. 

As part of this process, FDA is soliciting 

public comment on the draft guidance 

made available here. Similarly, as part 

of the Agency’s ongoing efforts to 

address industry questions, FDA 

continues to solicit public input and 

consider approaches with respect to 

several related issues, including the 

following: 

(1) Further explaining ‘‘scientific 

exchange.’’ On December 28, 2011, FDA 

issued a Federal Register notice (76 FR 

81508) opening a docket and requesting 

comments and information related to 

‘‘scientific exchange.’’ Comments were 

submitted to Docket No. FDA–2011–N– 

0912. FDA is reviewing those comments 

and considering how that information 

may inform future Agency action related 

to its policies on communications and 

activities related to unapproved or 

uncleared uses of marketed drugs and 

devices, as well as communications and 

activities related to use of products that 

are not yet legally marketed for any use. 

mstockstill on DSK4VPTVN1PROD with NOTICES