18660 Federal Register / Vol. 72, No. 71 / Friday, April 13, 2007 / Notices 

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 May 14, 

2007. 

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: 

202–395–6974. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

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. 

Adoption of the Food and Drug 

Administration Food Code by Local, 

State, and Tribal Governments (OMB 

Control Number 0910–0448)—Extension 

FDA has developed its model Food 

Code to assist and promote consistent 

implementation of national food safety 

regulatory policy among the local, State, 

and tribal governmental agencies that 

have primary responsibility for the 

regulation or oversight of retail level 

food operations. The FDA Food Code 

provides a scientifically sound technical 

and legal basis for regulating the retail 

segment of the food industry. Authority 

for providing such assistance is derived 

from section 311(a) of the Public Health 

Service Act (42 U.S.C. 243(a)). Under 31 

U.S.C. 1535, FDA provides assistance to 

other Federal agencies such as the 

Indian Health Service. 

Nationwide adoption of the model 

FDA Food Code is an important step 

toward the agency’s goal for consistent, 

scientifically sound, and risk-based food 

safety standards and practices. A 

current, comprehensive, and accurate 

inventory of food code adoptions by 

States and U.S. territories, local, and 

tribal governments is necessary to 

determine the status of up-to-date 

protection of the U.S. population and to 

identify areas where assistance to these 

governments may promote the adoption 

of regulations based on the FDA Food 

Code. 

This collection effort, which began in 

2001, has had remarkable success with 

97 percent participation from State and 

territorial governmental agencies. FDA 

contracted with the Association of Food 

and Drug Officials (AFDO) to conduct 

the initial survey using the OMB 

approved survey form. The rulemaking 

process that local, State, territorial, and 

tribal governmental agencies must 

follow to adopt the model FDA Food 

Code is often a long and complicated 

process that can extend for several 

years. For this reason, many agencies 

have reported that they are still in the 

rulemaking process to adopt or update 

their food codes. Thus, FDA believes 

that extension of OMB approval of the 

survey is needed in order to keep the 

current database accurate and up-todate. AFDO will collect the information 

electronically and/or telephonically and 

will be able to provide respondents with 

previous survey responses already in 

the database. 

Description of Respondents: States 

and U.S. territories, local, and tribal 

governmental agencies. 

In the Federal Register of January 26, 

2007 (72 FR 3862), FDA published a 60- 

day notice requesting public comment 

on the information collection 

provisions. We received one comment, 

which was non-responsive to our 

request for comments on the proposed 

information collection. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Food Code Survey No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Respondents 75 4 300 1 300 

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

This estimate is based on FDA’s 

experience and the number of updates 

received in the past 3 years. FDA has 

reduced the estimated number of annual 

respondents from 150 to 75. FDA 

estimates that 75 respondents will 

provide four quarterly updates each, 

resulting in an estimated 300 total 

annual responses. The agency estimates 

that each quarterly update will take 

about 1 hour. Of the 75 respondents, 

those who amend their regulations with 

changes unrelated to the risk factors and 

interventions, and those who are not 

adopting model FDA Food Code 

provisions, but are incorporating certain 

Conference for Food Protection 

recommendations only, will likely need 

only annual contact. 

Dated: April 9, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–6983 Filed 4–12–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0525] 

Supplements and Other Changes to an 

Approved Application; Public Meeting; 

Reopening of Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of comment 

period. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening until 

May 18, 2007, the comment period for 

a notice of public meeting that 

published in the Federal Register of 

January 5, 2007 (72 FR 574). In the 

notice, FDA announced a February 7, 

2007, meeting to solicit input on issues 

that the agency should consider if it 

decides to propose revisions to its 

regulations regarding chemistry, 

manufacturing, and controls (CMC) 

supplements and other changes to 

approved marketing applications for 

human drugs. FDA is reopening the 

comment period in light of continued 

public interest in this topic. 

DATES: Submit written or electronic 

comments by May 18, 2007. 

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 


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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 


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