56592 Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Notices 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: September 24, 2008. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E8–22752 Filed 9–26–08; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Proposed Information Collection 

Activity; Comment Request 

Proposed Projects 

Title: Protection and Advacacy (P&A) 

Voting Access Application and Annual 

Report. 

OMB No.: 0970–0326. 

Description: This is a revision to 

include the application for the 

previously cleared Help America Vote 

Act (HAVA) Annual report. 

An application is required by Federal 

statute (the Help America Vote Act 

(HAVA) of 2002, Pub. L. 107–252, 

Section 291, Payments for Protection 

and Advocacy Systems, 42 U.S.C. 

15461). Each State Protection & 

Advocacy (P&A) System must prepare 

an application in accordance with the 

program announcement. 

There is no application kit; the P&As 

application may be in the format of its 

choice. It must, however, be signed by 

the P&As Executive Director or the 

designated representative, and contain 

the assurances as outlined under 

Part I.C. Use of Funds. The P&As 

designated representatives may signify 

their agreement with the conditions/ 

assurances by signing and returning the 

assurance document Attachment B, 

found in Part IV of this Instruction. The 

assurance document signed by the 

Executive Director of the P&A, or other 

designated person, should be submitted 

with the application to the 

Administration on Developmental 

Disabilities. 

An annual report is required by 

Federal statute (the Help America Vote 

Act (HAVA) of 2002, Pub. L. 107–252, 

Section 291, Payments for Protection 

and Advocacy Systems, 42 U.S.C. 

15461). Each State Protection & 

Advocacy (P&A) System must prepare 

and submit an annual report at the end 

of every fiscal year. The report 

addresses the activities conducted with 

the funds provided during the year. The 

information from the annual report will 

be aggregated into an annual profile of 

how HAVA funds have been spent. The 

report will also provide an overview of 

the P&A goals and accomplishments 

and permit the Administration on 

Developmental Disabilities to track 

progress to monitor grant activities. 

Respondents: Protection & Advocacy 

Systems—All States, the District of 

Columbia, Puerto Rico, the U.S. Virgin 

Islands, American Samoa, and Guam. 

ANNUAL BURDEN ESTIMATES

Instrument Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden 

hours per 

response 

Total 

burden 

hours 

Protection and Advocacy (P&A) Voting Access Annual Report ...................... 55 1 16 880 

Protection and Advocacy (P&A) Voting Access Application ........................... 55 1 20 1,100 

Estimated Total Annual Burden 

Hours: 1,980. 

In compliance with the requirements 

of Section 506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

infocollection@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication. 

Dated: September 24, 2008. 

Janean Chambers, 

Reports Clearance Officer. 

[FR Doc. E8–22754 Filed 9–26–08; 8:45 am] 

BILLING CODE 4184–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0500] 

Agency Information Collection 

Activities; Proposed Collection; 

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 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 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Notices 56593 

notice. This notice solicits comments on 

the information collection provisions of 

FDA’s requirements on content and 

format of labeling for human 

prescription drug and biological 

products. 

DATES: Submit written or electronic 

comments on the collection of 

information by November 28, 2008. 

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: 

Elizabeth Berbakos, Office of 

Information Management (HFA–710), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–796–3792. 

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. 

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 to 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 3964 

through 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 will continue to 

be submitted to FDA during this multiyear 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. 

mstockstill on PROD1PC66 with NOTICES

56594 Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Notices 

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 

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. 

TABLE 1.—ESTIMATED 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 REPORTING BURDENS FOR LABELING REVISIONS TO ALREADY-APPROVED DRUG PRODUCTS1

Category (21 CFR Section) 

Year(s) In Which Burdens Occur After 

June 30, 2006 

No. of Respondents 

No. of Responses per 

Respondent 

Total Responses Hours per 

Response Total Hours Total Capital Costs 

Burden associated with revised labeling for applications approved within 5 

years prior to June 30, 

2006 (§ 201.57) 

Beginning year 3, 

ending year 7 

172 2 344 196 67,424 $3.3 million 

Burden associated with revised labeling for efficacy 

supplements submitted on 

or after June 30, 2006 

(§§ 201.56(d) and 201.57) 

Beginning year 3, diminishing over time 172 1.08 186 196 36,456 $2.5 million 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 73, No. 189 / Monday, September 29, 2008 / Notices 56595 

TABLE 2.—ESTIMATED REPORTING BURDENS FOR LABELING REVISIONS TO ALREADY-APPROVED DRUG PRODUCTS1— 

Continued 

Category (21 CFR Section) 

Year(s) In Which Burdens Occur After 

June 30, 2006 

No. of Respondents 

No. of Responses per 

Respondent 

Total Responses Hours per 

Response Total Hours Total Capital Costs 

Burden associated with revised labeling for efficacy 

supplements for generic 

drug products (§ 201.57) 

Beginning year 3, 

continuing annually 

thereafter 

42 8 336 (for 

years 1–10) 

27 9,072 $2.5 million 

Total 112,952 Up to $8.3 

million 

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

Please note that on January 15, 2008, 

the FDA Division of Dockets 

Management Web site transitioned to 

the Federal Dockets Management 

System (FDMS). FDMS is a 

Government-wide, electronic docket 

management system. Electronic 

comments or submissions will be 

accepted by FDA only through FDMS at 

http://www.regulations.gov. 

Dated: September 17, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–22731 Filed 9–26–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). To request a copy 

of the clearance requests submitted to 

OMB for review, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Office at (301) 443– 

1129. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: Data Collection Tool 

for State Offices of Rural Health Grant 

Program: (New) 

The mission of the Office of Rural 

Health Policy (ORHP) is to sustain and 

improve access to quality care services 

for rural communities. In its authorizing 

language (Sec. 711 of the Social Security 

Act [42 U.S.C. 912]), Congress charged 

ORHP with ‘‘administer[ing] grants, 

cooperative agreements, and contracts to 

provide technical assistance and other 

activities as necessary to support 

activities related to improving health 

care in rural areas.’’ 

The State Offices of Rural Health 

Grant Program (SORH) is authorized by 

Section 338J of the Public Health 

Service Act (42 U.S.C. 254r). The 

purpose of SORH is to assist States in 

strengthening their rural health care 

delivery systems by helping to support 

a focal point for rural health within each 

State. The program provides funding for 

an institutional framework that links 

rural hospitals, providers and 

communities with State and Federal 

resources to help develop long term 

solutions to rural health problems. The 

average annual award for each State 

based grantee is $150,000. The law 

provides for a Federal-State partnership, 

requiring a State funding match of $3 for 

each $1 of Federal funding. Over the 

past 16 years, this program has 

leveraged in excess of $200 million in 

State matching funds for rural health. 

For SORH, program performance 

measures were drafted to provide data 

useful to the program and to enable 

HRSA to provide aggregate program data 

required by Congress under the 

Government Performance and Results 

Act (GPRA) of 1993. ORHP seeks to 

collect information from grantees on 

their efforts to provide technical 

assistance to clients within their State. 

SORH grantees would be required to 

submit a Technical Assistance Report 

that includes: 1) The total number of 

technical assistance encounters 

provided directly by the grantee; and, 2) 

the total number of clients that received 

direct technical assistance from the 

grantee. Submission of the Technical 

Assistance Report would be done via email to ORHP no later than 30 days after 

the end of each twelve month budget 

period. 

The estimated average annual burden 

is as follows: 

Form Number of 

respondents 

Responses 

per 

respondent 

Total 

responses 

Hours per 

response 

Total burden 

hours 

Technical Assistance Report ............................................... 50 1 50 12.5 625 

Total .............................................................................. 50 ........................ ........................ ........................ 625 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to 

the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov 

or by fax to 202–395–6974. Please direct 

all correspondence to the ‘‘attention of 

the desk officer for HRSA.’’ 

Dated: September 22, 2008 

Alexandra Huttinger, 

Director, Division of Policy Review and 

Coordination. 

[FR Doc. E8–22728 Filed 9–26–08; 8:45 am] 

BILLING CODE 4165–15–P 

mstockstill on PROD1PC66 with NOTICES