904 Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 

Providers and Systems) Home Health 

Care Survey. The Home Health Care 

CAHPS survey, as initially discussed in 

the May 4, 2007 Federal Register (72 FR 

25356, 25452), is part of a family of 

CAHPS® surveys that ask patients about 

their health care experiences. The Home 

Health Care CAHPS survey, developed 

by the Agency for Healthcare Research 

and Quality (AHRQ), creates a 

standardized survey for home health 

patients to assess their home health care 

providers and the quality of their home 

health care. Prior to this survey, there 

was no national standard for collecting 

such information that would allow 

comparisons across all home health 

agencies. 

AHRQ conducted a field test to 

determine the length and content of the 

Home Health Care CAHPS Survey. CMS 

has submitted the survey to the National 

Quality Forum (NQF) for consideration 

and approval in their consensus 

process. NQF endorsement represents 

the consensus opinion of many 

healthcare providers, consumer groups, 

professional organizations, purchasers, 

federal agencies, and research and 

quality organizations. The final survey 

has also been submitted to the Office of 

Management and Budget (OMB) for 

their approval under the Paperwork 

Reduction Act (PRA) process. 

The survey captures topics such as 

patients’ interactions with the agency, 

access to care, interactions with home 

health staff, provider care and 

communication, and patient 

characteristics. The survey allows the 

patient to give an overall rating of the 

agency, and asks if the patient would 

recommend the agency to family and 

friends. 

CMS is beginning plans for 

implementation of Home Health Care 

CAHPS Survey. Administration of the 

survey will be conducted by multiple, 

independent survey vendors working 

under contract with home health 

agencies to facilitate data collection and 

reporting. Recruitment and training of 

vendors who wish to be approved to 

collect Home Health Care CAHPS data 

will begin in 2009. Home health 

agencies interested in learning about the 

survey and/or voluntarily participating 

in the survey are encouraged to view the 

Home Health Care CAHPS Web site: 

http://www.homehealthCAHPS.org. 

Information about the project can also 

be obtained by sending an e-mail to 

HHCAHPS@rti.org. 

Home health agency participation in 

the Home Health Care CAHPS Survey is 

currently voluntary. Form Number: 

CMS–10275 (OMB# 0938–New); 

Frequency: Semi-annually, once and 

occasionally; Affected Public: 

Individuals or households; Number of 

Respondents: 2,706,000; Total Annual 

Responses: 2,706,000; Total Annual 

Hours: 541,200. 

3. Type of Information Collection 

Request: Extension of a currently 

approved collection; Title of 

Information Collection: Application for 

Prescription Drug Plans (PDP); 

Application for Medicare Advantage 

Prescription Drug (MA–PD); 

Application for Cost Plans to Offer 

Qualified Prescription Drug Coverage; 

Application for Employer Group Waiver 

Plans to Offer Prescription Drug 

Coverage; Service Area Expansion 

Application for Prescription Drug 

Coverage; Use Collection of this 

information is mandated in Part D of the 

Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 and under supporting regulations 

Subpart K of 42 CFR 423 entitled 

‘‘Application Procedures and Contracts 

with PDP Sponsors.’’ 

Coverage for the prescription drug 

benefit is provided through contracted 

prescription drug plans (PDPs) or 

through Medicare Advantage (MA) 

plans that offer integrated prescription 

drug and health care coverage (MA–PD 

plans). Cost Plans that are regulated 

under Section 1876 of the Social 

Security Act, and Employer Group 

Waiver Plans (EGWP) may also provide 

a Part D benefit. Organizations wishing 

to provide services under the 

Prescription Drug Benefit Program must 

complete an application, negotiate rates 

and receive final approval from CMS. 

Existing Part D Sponsors may also 

expand their contracted service area by 

completing the Service Area Expansion 

(SAE) application. The information will 

be collected under the solicitation of 

proposals from PDP, MA–PD, Cost Plan, 

PACE, and EGWP Plan applicants. The 

collected information will be used by 

CMS to: (1) Ensure that applicants meet 

CMS requirements, (2) support the 

determination of contract awards. Form 

Number: CMS–10137(OMB#: 0938– 

0936); Frequency: Reporting–Once; 

Affected Public: Business or other forprofit and not-for-profit institutions; 

Number of Respondents: 455; Total 

Annual Responses: 455; Total Annual 

Hours: 11,890. 

To obtain copies of the supporting 

statement and any related forms for the 

proposed paperwork collections 

referenced above, access CMS’s 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 March 10, 2009: 

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 ll, Room C4–26–05, 

7500 Security Boulevard, Baltimore, 

Maryland 21244–1850. 

Dated: December 30, 2008. 

Michelle Shortt, 

Director, Regulations Development Group, 

Office of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. E9–65 Filed 1–8–09; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0500] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Requirements on 

Content and Format of Labeling for 

Human Prescription Drug and 

Biological Products 

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 February 9, 

2009. 

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: 

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Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 905 

202–395–6974, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0572. 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 (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 

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. 

Requirements on Content and Format of 

Labeling for Human Prescription Drug 

and Biological Products (OMB Control 

Number 0910–0572)—Extension 

FDA’s final rule entitled 

‘‘Requirements on Content and Format 

of Labeling for Human Prescription 

Drug and Biological Products’’ (the final 

rule), which published on January 24, 

2006 (71 FR 3922), and was effective on 

June 30, 2006, amended FDA’s 

regulations governing the format and 

content of labeling for human 

prescription drug and biological 

products to require that the labeling of 

new and recently approved products 

contain highlights of prescribing 

information, a table of contents for 

prescribing information, reordering of 

certain sections, minor content changes, 

and minimum graphical requirements. 

These revisions were intended to make 

it easier for health care practitioners to 

access, read, and use information in 

prescription drug labeling, to enhance 

the safe and effective use of prescription 

drug products, and reduce the number 

of adverse reactions resulting from 

medication errors due to misunderstood 

or incorrectly applied drug information. 

A. Summary of Prescription Drug 

Labeling Content and Format 

Requirements That Contain Collections 

of Information 

Section 201.56 (21 CFR 201.56) 

requires that prescription drug labeling 

contain certain information in the 

format specified in either § 201.57 (21 

CFR 201.57) or § 201.80 (21 CFR 

201.80), depending on when the drug 

was approved for marketing. 

Section 201.56(a) sets forth general 

labeling requirements applicable to all 

prescription drugs. Section 201.56(b) 

specifies the categories of new and more 

recently approved prescription drugs 

subject to the revised content and 

format requirements in §§ 201.56(d) and 

201.57. Section 201.56(c) sets forth the 

schedule for implementing these revised 

content and format requirements. 

Section 201.56(e) specifies the sections 

and subsections, required and optional, 

for the labeling of older prescription 

drugs not subject to the revised format 

and content requirements. 

Section 201.57(a) requires that 

prescription drug labeling for new and 

more recently approved prescription 

drug products include ‘‘Highlights of 

Prescribing Information.’’ Highlights 

provides a concise extract of the most 

important information required under 

§ 201.57(c) (the Full Prescribing 

Information (FPI)), as well as certain 

additional information important to 

prescribers. Section 201.57(b) requires a 

table of contents to prescribing 

information, entitled ‘‘Full Prescribing 

Information: Contents,’’ consisting of a 

list of each heading and subheading 

along with its identifying number to 

facilitate health care practitioners’ use 

of labeling information. Section 

201.57(c) specifies the contents of the 

FPI. Section 201.57(d) mandates the 

minimum specifications for the format 

of prescription drug labeling and 

establishes minimum requirements for 

key graphic elements such as bold type, 

bullet points, type size, and spacing. 

Older drugs not subject to the revised 

labeling content and format 

requirements in § 201.57 remain subject 

to labeling requirements at § 201.80 (in 

the final rule, former § 201.57 was 

redesignated as § 201.80). Section 

201.80(f)(2) requires that within 1 year, 

any FDA-approved patient labeling be 

referenced in the ‘‘Precautions’’ section 

of the labeling of older products and 

either accompany or be reprinted 

immediately following the labeling. 

B. Estimates of Reporting Burden 

The PRA information collection 

analysis in the final rule (71 FR 3922 at 

3964 to 3967) (currently approved under 

OMB Control Number 0910–0572) 

estimated the reporting burden for a 

multi-year period. We are requesting 

that OMB extend approval for the 

information in this collection, as 

described below, which continue to be 

submitted to FDA during this multi-year 

period. 

Annual Burden for Prescription Drug 

Labeling Design, Testing, and 

Submitting to FDA for New Drug 

Applications (NDAs) and Biologics 

License Applications (BLAs) (§§ 201.56 

and 201.57) (Table 1) 

New drug product applicants must: 

(1) Design and create prescription drug 

labeling containing Highlights, 

Contents, and FPI, (2) test the designed 

labeling (e.g., to ensure that the 

designed labeling fits into cartonenclosed products), and (3) submit it to 

FDA for approval. Based on the 

projected data estimated in the final 

rule, FDA estimates that it takes 

applicants approximately 3,349 hours to 

design, test, and submit prescription 

drug labeling to FDA as part of an NDA 

or BLA under the revised regulations. 

Approximately 85 applicants submit 

approximately 107 new applications 

(NDAs and BLAs) to FDA per year, 

totaling 358,343 hours. 

Burden Associated with Labeling 

Supplements for Applications 

Approved Within 5 Years Prior to the 

Effective Date of the Rule (§ 201.57) 

(Table 2) 

The final rule required that 

prescription drug applications approved 

during the 5 years before, or pending on, 

the effective date conform to format and 

content requirements at § 201.57. For 

these products, applicants must 

redesign and negotiate the labeling, 

including Highlights and Contents, test 

the redesigned labeling, and prepare 

and submit that labeling to FDA for 

approval. Based on the projected data 

estimated in the final rule, labeling 

supplements for a total of approximately 

344 innovator products are expected to 

be submitted to FDA over a 5-year 

period (beginning in year 3 and ending 

in year 7 after the effective date of the 

final rule). Approximately 172 

applicants submit these labeling 

supplements, and the time required for 

redesigning, testing, and submitting the 

labeling to FDA is approximately 196 

hours per application, totaling 67,424 

hours. 

Burden Associated with Revised 

Labeling Efficacy Supplements 

Submitted on or After the Effective Date 

of the Rule (§§ 201.56(d) and 201.57) 

(Table 2) 

Efficacy supplemental applications 

for older drugs submitted to FDA on or 

after the effective date of the final rule 

are subject to the content and format 

requirements of §§ 201.56(d) and 

201.57. To meet these requirements, 

applicants must revise the existing 

labeling for these products. Each year an 

increasing number of innovator drug 

labeling will have been revised, and 

over time, very few efficacy 

supplements independently will 

generate labeling revisions. Based on the 

projected data estimated in the final 

rule, the number of affected efficacy 

supplements over 10 years, beginning 

with year 3, is 186, with a decreasing 

number each year over the period. 

Approximately 172 applicants will 

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906 Federal Register / Vol. 74, No. 6 / Friday, January 9, 2009 / Notices 

trigger approximately 186 efficacy 

supplements, each one requiring 

approximately 196 hours to revise the 

labeling in the application, totaling 

36,456 hours. (As stated in the final 

rule, in addition to this burden, a 

minimal annual reporting burden (fewer 

than 7) will continue indefinitely). 

Burden Associated with Revised 

Labeling for Efficacy Supplements for 

Generic Drug Products (§ 201.57) (Table 

2) 

Based on the projected data estimated 

in the final rule, beginning in year 3 and 

continuing throughout the 10-year 

period analyzed, approximately 42 

generic applicants per year must submit 

labeling supplements. Approximately 

336 already approved generic drug 

applications must submit labeling 

supplements over the 10-year period 

after the effective date of the rule. The 

time required to revise and submit this 

labeling to FDA is approximately 27 

hours per application, totaling 9,072 

hours. (As stated in the final rule, in 

addition to this burden, a minimal 

annual reporting burden associated with 

a very small number of generic 

applications referencing older drugs 

may continue indefinitely). 

C. Capital Costs 

As discussed in the final rule, a small 

number of carton-enclosed products 

may require new packaging to 

accommodate longer inserts. As many as 

5 percent of the existing products 

affected by the final rule (i.e., products 

with new efficacy supplements, 

products approved in the 5 years prior 

to the effective date of the rule, and 

affected abbreviated new drug 

applications) may require equipment 

changes at an estimated cost of $200,000 

each product. 

In the Federal Register of September 

29, 2008 (73 FR 56592), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received 

relating to the paperwork. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN FOR NEW DRUG APPLICATIONS1

Category (21 CFR Section) No. of Respondents No. of Responses per 

Respondent 

Total 

Responses 

Hours per 

Response Total Hours 

Annual Burden for Labeling Requirements in §§ 201.56 and 201.57 85 1.26 107 3,349 358,343 

Total 358,343 

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

TABLE 2.—ESTIMATED ANNUAL REPORTING BURDENS FOR LABELING REVISIONS TO ALREADY-APPROVED DRUG

PRODUCTS1

Category (21 CFR Section) No. of Respondents No. of Responses per 

Respondent 

Total 

Responses 

Hours per 

Response Total Hours 

Burden associated with revised labeling for applications approved within 

5 years prior to June 30, 2006 

(§ 201.57) 172 2 344 196 67,424 

Burden associated with revised labeling for efficacy supplements submitted on or after June 30, 2006 

(§§ 201.56(d) and 201.57) 172 1.08 186 196 36,456 

Burden associated with revised labeling for efficacy supplements for generic drug products (§ 201.57) 42 8 336 27 9,072 

Total 112,952 

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

Dated: December 24, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–175 Filed 1–8–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0657] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Recommendations 

for the Early Food Safety Evaluation of 

New Non-Pesticidal Proteins Produced 

by New Plant Varieties Intended for 

Food Use 

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 

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