Federal Register / Vol. 75, No. 232 / Friday, December 3, 2010 / Notices 75475 

contact: nationalconversation@cdc.gov 

or Julie Fishman at 770–488–0629. 

Tanja Popovic, 

Deputy Associate Director for Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2010–30165 Filed 12–2–10; 8:45 am] 

BILLING CODE P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–437] 

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 

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 currently 

approved collection; Title of 

Information Collection: Psychiatric Unit 

Criteria Work Sheet and Supporting 

Regulations 412.25 and 412.27; Use: 

Certain hospital units are excluded from 

the Medicare Prospective Payment 

System (PPS). The exclusion of units is 

not optional on the part of the provider 

but is required by section 1886(d)(1)(B) 

of the Social Security Act. That section 

excludes psychiatric hospitals, 

rehabilitation hospitals, hospitals whose 

inpatients are predominantly 

individuals under 18 years of age 

(children’s hospitals), and psychiatric 

and rehabilitation units which are a 

distinct part of a hospital. 

CMS proposes to continue the current 

process of performing initial 

verifications and annual reverifications 

to determine that psychiatric units 

continue to comply with the regulatory 

criteria at 42 CFR 412.25 and 42 CFR 

412.27 of the PPS regulations. These 

regulations state the criteria that distinct 

part units must meet for exclusion. 

If, as a result of the regular survey 

process a hospital is certified as a 

psychiatric hospital by the State survey 

agency (SA), then it automatically 

satisfies the regulatory criteria for 

exclusion. Thus, no additional 

verification is required for psychiatric 

hospitals. Some verification is needed, 

however, to ensure that other types of 

hospitals and units meet the criteria for 

exclusion. 

Consequently, CMS instructed the 

Fiscal Intermediaries (FIs) and SAs to 

perform certain verification activities, 

beginning in October 1983 when PPS 

was implemented. CMS originally 

developed the CMS–437 as SA 

Worksheet for verifying exclusions from 

PPS for psychiatric units. 

Since April 9, 1994, PPS-excluded 

psychiatric units already excluded from 

the PPS have met CMS’s annual 

requirement for PPS-exclusion by selfattesting that they remain in compliance 

with the PPS exclusion criteria. Under 

the current procedure, all psychiatric 

units applying for first-time exclusion 

are surveyed by the SAs. The SAs also 

perform surveys to investigate 

complaint allegations and conduct 

annual sample reverification surveys on 

5 percent of all psychiatric units. 

The aforementioned exclusions 

continue to exist and thus CMS 

proposes to continue to use the Criteria 

Worksheet, Forms CMS–437 for 

verifying first-time exclusions from the 

PPS, for complaint surveys, for its 

annual 5 percent validation sample, and 

for facility self-attestation. These forms 

are related to the survey and 

certification and Medicare approval of 

the PPS-excluded units. Form Number: 

CMS–437 (OMB#: 0938–0358); 

Frequency: Annually; Affected Public: 

Private sector businesses or other forprofits; Number of Respondents: 1,333; 

Total Annual Responses: 1,333; Total 

Annual Hours: 333. (For policy 

questions regarding this collection 

contact Kelley Leonette at 410–786– 

6664. 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 

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 February 1, 2011: 

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, Room C4–26–05, 7500 

Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: November 24, 2010. 

Martique Jones, 

Director, Regulations Development DivisionB, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2010–30367 Filed 12–2–10; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0597] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Index of Legally 

Marketed Unapproved New Animal 

Drugs for Minor Species 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. 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 of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the burden hours associated with 

indexing of legally marketed 

unapproved new animal drugs for minor 

species. 

mstockstill on DSKH9S0YB1PROD with NOTICES

75476 Federal Register / Vol. 75, No. 232 / Friday, December 3, 2010 / Notices 

DATES: Submit either electronic or 

written comments on the collection of 

information by February 1, 2011. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Johnny Vilela, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

7651, juanmanuel.vilela@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 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. 

‘‘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 provide a 60-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Index of Legally Marketed Unapproved 

New Animal Drugs for Minor Species— 

21 CFR Part 516 (OMB Control Number 

0910–0620)—Extension 

The Minor Use and Minor Species 

Animal Health Act of 2004 (MUMS Act) 

amended the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) to 

authorize FDA to establish new 

regulatory procedures intended to make 

more medications legally available to 

veterinarians and animal owners for the 

treatment of minor animal species 

(species other than cattle, horses, swine, 

chickens, turkeys, dogs, and cats), as 

well as uncommon diseases in major 

animal species. 

The MUMS Act added three new 

sections to the FD&C Act (sections 571, 

572, and 573 (21 U.S.C. 360ccc, 360ccc– 

1, and 360ccc–2, respectively)). The 

final rule (72 FR 69108, December 6, 

2007) implements section 572 of the 

FD&C Act, which provides for an index 

of legally marketed unapproved new 

animal drugs for minor species. 

Participation in any part of the MUMS 

program is optional so the associated 

paperwork only applies to those who 

choose to participate. The final rule 

specifies, among other things, the 

criteria and procedures for requesting 

eligibility for indexing and for 

requesting addition to the index as well 

as the annual reporting requirements for 

index holders. 

Under the new subpart C of part 516 

(21 CFR part 516, subpart C), § 516.119 

provides requirements for naming a 

permanent-resident U.S. agent by 

foreign drug companies, and § 516.121 

provides for informational meetings 

with FDA. Section 516.123 provides 

requirements for requesting informal 

conferences regarding agency 

administrative actions and § 516.125 

provides for investigational use of new 

animal drugs intended for indexing. 

Provisions for requesting a 

determination of eligibility for indexing 

can be found under § 516.129 and 

provisions for subsequent requests for 

addition to the index can be found 

under § 516.145. A description of the 

written report required in § 516.145 can 

be found under § 516.143. Under 

§ 516.141 are provisions for drug 

companies to nominate a qualified 

expert panel as well as the panel’s 

recordkeeping requirements. This 

section also calls for the submission of 

a written conflict of interest statement to 

FDA by each proposed panel member. 

Index holders are able to modify their 

index listing under § 516.161 or change 

drug ownership under § 516.163. 

Requirements for records and reports 

are under § 516.165. 

Description of Respondents: 

Pharmaceutical companies that sponsor 

new animal drugs. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section Number of 

respondents 

Annual 

frequency per 

response 

Total annual 

responses 

Hours per 

response Total hours 

516.119 ................................................................................ 2 1 2 1 2 

516.121 ................................................................................ 30 2 60 4 240 

516.123 ................................................................................ 3 1 3 8 24 

516.125 ................................................................................ 2 3 6 20 120 

516.129 ................................................................................ 30 2 60 20 1,200 

516.141 ................................................................................ 20 1 20 16 320 

516.143 ................................................................................ 20 1 20 120 2,400 

516.145 ................................................................................ 20 1 20 20 400 

516.161 ................................................................................ 1 1 1 4 4 

516.163 ................................................................................ 1 1 1 2 2 

516.165 ................................................................................ 10 2 20 8 160 

Total .............................................................................. ........................ ........................ ........................ ........................ 4,872 

1 There are no capital costs or operating and maintenance costs associated with this collection of information. 

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Federal Register / Vol. 75, No. 232 / Friday, December 3, 2010 / Notices 75477 

1For prescription drugs and biologics, the FD&C 

Act requires advertisements to contain ‘‘information 

in brief summary relating to side effects, 

contraindications, and effectiveness’’ (21 U.S.C. 

352(n)). 

2See Schwartz, L., S. Woloshin, W. Black, et al., 

‘‘The Role of Numeracy in Understanding the 

Benefit of Screening Mammography,’’ Annals of 

Internal Medicine, 127(11), 966–72, 1997. 

3Woloshin, S. and L. Schwartz, ‘‘Direct to 

Consumer Advertisements for Prescription Drugs: 

What Are Americans Being Told,’’ Lancet, 358, 

1141–46, 2001. 

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section No. of 

recordkeepers 

Annual frequency per 

recordkeeper 

Total annual 

records 

Hours per 

recordkeeper Total hours 

516.141 ................................................................................ 30 2 60 0.5 30 

516.165 ................................................................................ 10 2 20 1 20 

Total .............................................................................. ........................ ........................ ........................ ........................ 50 

1 There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: November 29, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–30316 Filed 12–2–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0266] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Study of Clinical 

Efficacy Information in Professional 

Labeling and Direct-to-Consumer Print 

Advertisements for Prescription Drugs 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by January 3, 

2011. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910-new and title 

‘‘Study of Clinical Efficacy Information 

in Professional Labeling and Direct-toConsumer (DTC) Print Advertisements 

for Prescription Drugs.’’ Also include the 

FDA docket number found in brackets 

in the heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 301– 

796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. Study of Clinical 

Efficacy Information in Professional 

Labeling and Direct-to-Consumer (DTC) 

Print Advertisements for Prescription 

Drug—(OMB Control Number 0910– 

New) 

Section 1701(a)(4) of the Public 

Health Service Act (42 U.S.C. 

300u(a)(4)) authorizes FDA to conduct 

research relating to health information. 

Section 903(b)(2)(c) of the Federal Food, 

Drug, and Cosmetic Act (FD&C Act) (21 

U.S.C. 393(b)(2)(c)) authorizes FDA to 

conduct research relating to drugs and 

other FDA-regulated products in 

carrying out the provisions of the FD&C 

Act. 

FDA regulations require that an 

advertisement that makes claims about 

a prescription drug include a ‘‘fair 

balance’’ of information about the 

benefits and risks of the advertised 

product, in terms of both content and 

presentation (21 CFR 202.1(e)(5)(ii)). In 

past research FDA has focused primarily 

on the risk component of the riskbenefit ratio. In the interest of 

thoroughly exploring the issue of fair 

balance, however, the presentation of 

effectiveness, or benefit, information is 

equally important. 

The FD&C Act requires that 

manufacturers, packers, and distributors 

(sponsors) who advertise prescription 

human and animal drugs, including 

biological products for humans, disclose 

in advertisements certain information 

about the advertised product’s uses and 

risks.1 By its nature, the presentation of 

this risk information is likely to evoke 

active trade-offs by consumers, i.e., 

comparisons with the perceived risks of 

not taking treatment, and comparisons 

with the perceived benefits of taking a 

treatment.2 Since FDA has an interest in 

fostering safe and proper use of 

prescription drugs, an activity that 

engages both risks and benefits, an indepth understanding of consumers’ 

processing of this information is central 

to this regulatory task. 

Research and guidance to sponsors on 

how to present benefit and efficacy 

information in prescription drug 

advertisements is limited. For example, 

‘‘benefit claims,’’ broadly defined, 

appearing in advertisements are often 

presented in general language that does 

not inform patients of the likelihood of 

efficacy and are often simply variants of 

an ‘‘intended use’’ statement. In a 

content analysis of DTC advertising,3

the researchers classified the 

‘‘promotional techniques’’ used in the 

advertisements. Emotional appeals were 

observed in 67 percent of the ads while 

vague and qualitative benefit 

terminology was found in 87 percent of 

the ads. Only 9 percent contained data. 

For risk information, however, half the 

advertisements used data to describe 

side-effects, typically with lists of sideeffects that generally occurred 

infrequently. 

FDA regulations require that 

prescription drug advertisements that 

make (promotional) claims about a 

product also include risk information in 

a ‘‘balanced’’ manner (21 CFR 

202.1(e)(5)(ii)), both in terms of the 

content and presentation of the 

information. This balance applies to 

both the front (aka ‘‘display’’) page of an 

advertisement, as well as the brief 

summary page. However, beyond the 

‘‘balance’’ requirement limited guidance 

and research exists to direct or 

encourage sponsors to present benefit 

claims that are informative, specific, 

and reflect clinical effectiveness data. 

The purpose of this project is to: (1) 

Understand how physicians process 

clinical efficacy information and how 

mstockstill on DSKH9S0YB1PROD with NOTICES