Federal Register / Vol. 72, No. 71 / Friday, April 13, 2007 / Notices 18661 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

David J. Cummings, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 21, rm. 3525, 

Rockville, MD 20993–0002, 301–796–

2400, e-mail: 

David.Cummings@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On February 7, 2007, FDA held a 

public meeting to solicit comments on 

issues that FDA should consider if it 

decides to propose revisions to § 314.70 

(21 CFR 314.70) regarding CMC 

supplements and other changes to 

approved marketing applications for 

human drugs. In the notice announcing 

the public meeting (72 FR 574), FDA 

stated that current § 314.70 categorizes 

postapproval CMC changes and their 

associated reporting requirements 

without consideration of the applicant’s 

risk management activities or internal 

quality systems and practices; therefore, 

§ 314.70 reflects a rules-based, or 

prescriptive, approach to regulating 

postapproval manufacturing changes. 

Current § 314.70 may create regulatory 

burdens and costs that discourage 

beneficial manufacturing changes and 

may not support a desirable level of 

innovation, modernization, and 

flexibility for the industry as described 

in FDA’s pharmaceutical current good 

manufacturing practices for the 21st 

century initiative (CGMP Initiative). 

Consistent with the agency’s risk-based 

approach to regulating pharmaceutical 

manufacturing described in the CGMP 

Initiative, FDA is considering possible 

revisions to § 314.70 to allow for more 

manufacturing changes to be made 

without prior FDA approval using a 

firm’s internal change control system 

and to allow for consideration of riskbased approaches based on 

manufacturing process understanding, 

including prior knowledge of similar 

products, and overall quality systems to 

provide an enhanced risk-based 

approach to the CMC regulatory process. 

Interested persons were given until 

March 7, 2007, to submit written or 

electronic comments to the agency 

related to the focus of the public 

meeting. As a result of continued public 

interest, FDA is reopening the comment 

period until May 18, 2007, to allow 

interested persons additional time to 

submit comments. 

II. Request for Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments related to this topic (see 

DATES). All relevant data and 

information should be submitted with 

the written comments. Submit a single 

copy of electronic comments or two 

paper copies of any mailed comments, 

except that individuals may submit one 

copy. Comments are to be identified 

with Docket No. 2006N–0525. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Dated: April 5, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–6985 Filed 4–12–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, Pub. 

L. 104–13), the Health Resources and 

Services Administration (HRSA) 

publishes periodic summaries of 

proposed projects being developed for 

submission to the Office of Management 

and Budget (OMB) under the Paperwork 

Reduction Act of 1995. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and draft instruments, call the 

HRSA Reports Clearance Officer on 

(301) 443–1129. 

Comments are invited 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) 

ways to enhance 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. 

Proposed Project: Bureau of Primary 

Health Care (BPHC) Uniform Data 

System (OMB No. 0915–0193) Revision 

for 2008 

The Uniform Data System (UDS) 

contains the annual reporting 

requirements for the cluster of primary 

care grantees funded by the Health 

Resources and Services Administration 

(HRSA). The UDS includes reporting 

requirements for grantees of the 

following primary care programs: 

Community Health Centers, Migrant 

Health Centers, Health Care for the 

Homeless, Public Housing Primary Care, 

and other grantees under Section 330. 

The authorizing statute is section 330 of 

the Public Health Service Act, as 

amended. 

HRSA collects data in the UDS which 

is used to ensure compliance with 

legislative mandates and to report to 

Congress and policymakers on program 

accomplishments. To meet these 

objectives, BPHC requires a core set of 

data collected annually that is 

appropriate for monitoring and 

evaluating performance and reporting 

on annual trends. The 2008 calendar 

year UDS will be revised in several 

ways. Certain UDS tables are being 

proposed for elimination or 

modification to streamline data 

collection and reporting. A limited 

number of clinical measures will be 

added for reporting quality of care, 

health outcomes, and disparities data. In 

addition, the tool used to report 

calendar year UDS data will be changed 

to a Web-based tool. 

Estimates of Annualized Reporting 

Burden are as Follows: 

Type of report Number of 

respondents 

Responses 

per 

respondent 

Hours per 

response 

Total burden 

hours 

Universal report ............................................................................................... 1076 1 30 32,280

Grant report ..................................................................................................... 240 1 18 4,320

Total .......................................................................................................... 1076 ........................ ........................ 36,600 


pwalker on PROD1PC71 with NOTICES
18662 Federal Register / Vol. 72, No. 71 / Friday, April 13, 2007 / Notices 

Send comments to Susan G. Queen, 

PhD, HRSA Reports Clearance Officer, 

Room 10–33, Parklawn Building, 5600 

Fishers Lane, Rockville, MD 20857. 

Written comments should be received 

within 60 days of this notice. 

Dated: April 6, 2007. 

Caroline Lewis, 

Acting Associate Administrator for 

Administration and Financial Management. 

[FR Doc. E7–6991 Filed 4–12–07; 8:45 am] 

BILLING CODE 4165–15–P 

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. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, call the HRSA Reports 

Clearance Office on (301) 443–1129. 

The following request has been 

submitted to OMB for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: The Health Education 

Assistance Loan Program: Physician’s 

Certification of Borrower’s Total and 

Permanent Disability Form (OMB No. 

0915–0204 Extension) 

The Health Education Assistance 

Loan (HEAL) program provided 

federally-insured loans to students in 

schools of allopathic medicine, 

osteopathic medicine, dentistry, 

veterinary medicine, optometry, 

podiatric medicine, pharmacy, public 

health, allied health or chiropractic, and 

graduate students in health 

administration or clinical psychology 

through September 30, 1998. Eligible 

lenders, such as banks, savings and loan 

associations, credit unions, pension 

funds, State agencies, HEAL schools, 

and insurance companies, were 

permitted to refinance HEAL loans 

which were insured by the Federal 

Government against loss due to 

borrower’s death, disability, bankruptcy, 

and default until the authority to 

refinance HEAL loans expired on 

September 30, 2004. The basic purpose 

of the program was to assure the 

availability of funds for loans to eligible 

students who needed to borrow money 

to pay for their educational loans. 

Currently, the program monitors the 

Federal liability and assists in default 

prevention activities. The HEAL 

borrower, the borrower’s physician, and 

the holder of the loan completes the 

Physician’s Certification form to certify 

that the HEAL borrower meets the total 

and permanent disability provisions. 

The Department uses this form to 

obtain detailed information about 

disability claims which includes the 

following: (1) The borrower’s consent to 

release medical records to the 

Department of Health and Human 

Services and to the holder of the 

borrower’s HEAL loans, (2) pertinent 

information supplied by the certifying 

physician, (3) the Physician’s 

Certification that the borrower is unable 

to engage in any substantial gainful 

activity because of a medically 

determined impairment that is expected 

to continue for a long and indefinite 

period of time or to result in death, and 

(4) information from the lender on the 

unpaid balance. Failure to submit the 

required documentation will result in 

disapproval of a disability claim. 

The estimate of burden for the 

Physician’s Certification form is as 

follows: 

Type of respondent Number of 

respondents 

Responses 

per respondent 

Number of 

responses 

Minutes per 

response 

Total burden 

hours 

Borrower ............................................................................... 80 1 80 5 7 

Physician .............................................................................. 80 1 80 30 40 

Loan Holder ......................................................................... 17 5 85 10 14 

Total .............................................................................. 177 ........................ 245 ........................ 61 

Written comments and 

recommendations concerning the 

proposed information collection should 

be sent within 30 days of this notice to: 

Karen Matsuoka, Health Resources and 

Services Administration, Human 

Resources and Housing Branch, OMB, 

New Executive Office Building, Room 

10235, Washington, DC 20503. 

Dated: April 6, 2007. 

Caroline Lewis, 

Acting Associate Administrator for 

Administration and Financial Management. 

[FR Doc. E7–6992 Filed 4–12–07; 8:45 am] 

BILLING CODE 4165–15–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Vaccine Injury Compensation 

Program; List of Petitions Received 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: The Health Resources and 

Services Administration (HRSA) is 

publishing this notice of petitions 

received under the National Vaccine 

Injury Compensation Program (‘‘the 

Program’’), as required by Section 

2112(b)(2) of the Public Health Service 

(PHS) Act, as amended. While the 

Secretary of Health and Human Services 

is named as the respondent in all 

proceedings brought by the filing of 

petitions for compensation under the 

Program, the United States Court of 

Federal Claims is charged by statute 

with responsibility for considering and 

acting upon the petitions. 

FOR FURTHER INFORMATION CONTACT: For 

information about requirements for 

filing petitions, and the Program is 

general, contact the Clerk, United States 

Court of Federal Claims, 717 Madison 

Place, NW., Washington, DC 20005, 

(202) 357–6400. For information on 

HRSA’s role in the Program, contact the 

Director, National Vaccine Injury 

Compensation Program, 5600 Fishers 

Lane, Room 11C–26, Rockville, MD 

20857; (301) 443–6593. 

SUPPLEMENTARY INFORMATION: The 

Program provides a system of no-fault 

compensation for certain individuals 

who have been injured by specified 

childhood vaccines. Subtitle 2 of Title 

XXI of the PHS Act, 42 U.S.C. 300aa–

10 et seq., provides that those seeking 


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