52790 Federal Register / Vol. 72, No. 179 / Monday, September 17, 2007 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 111 

[Docket No. 2007N–0186] 

RIN 0910–AB88 

Petition to Request an Exemption 

From 100 Percent Identity Testing of 

Dietary Ingredients: Current Good 

Manufacturing Practice in 

Manufacturing, Packaging, Labeling, or 

Holding Operations for Dietary 

Supplements; Extension of Comment 

Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Interim final rule; extension of 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is extending to 

October 24, 2007, the comment period 

for the interim final rule (IFR) that 

appeared in the Federal Register of June 

25, 2007 (72 FR 34959). In the IFR, FDA 

requested comments on a procedure for 

a petition to request an exemption from 

100 percent identity testing of dietary 

ingredients. The agency is taking this 

action in response to requests for an 

extension to allow interested persons 

additional time to submit comments. 

DATES: Submit written and electronic 

comments by October 24, 2007. 

ADDRESSES: You may submit comments, 

identified by Docket No. 2007N–0186, 

and/or Regulation Identifier Number 

(RIN) 0910–AB88, by any of the 

following methods: 

Electronic Submissions 

Submit electronic comments in the 

following ways: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Agency Web site: http:// 

www.fda.gov/dockets/ecomments. 

Follow the instructions for submitting 

comments on the agency Web site. 

Written Submissions 

Submit written submissions in the 

following ways: 

• FAX: 301–827–6870. 

• Mail/Hand delivery/Courier [For 

paper, disk, or CD–ROM submissions]: 

Division of Dockets Management (HFA–

305), Food and Drug Administration, 

5630 Fishers Lane, rm. 1061, Rockville, 

MD 20852. 

To ensure more timely processing of 

comments, FDA is no longer accepting 

comments submitted to the agency by email. FDA encourages you to continue 

to submit electronic comments by using 

the Federal eRulemaking Portal or the 

agency Web site, as described 

previously in the ADDRESSES portion of 

this document under Electronic 

Submissions. 

Instructions: All submissions received 

must include the agency name and 

Docket No(s). and/or RIN for this 

rulemaking. All comments received may 

be posted without change to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm, including any personal 

information provided. For additional 

information on submitting comments, 

see the ‘‘Comments’’ heading of the 

SUPPLEMENTARY INFORMATION section of 

this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http:// 

www.fda.gov/ohrms/dockets/ 

default.htm and insert the docket 

number(s), found in brackets in the 

heading of this document, into the 

‘‘Search’’ box and follow the prompts 

and/or go to the Division of Dockets 

Management, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Vasilios Frankos, Center for Food Safety 

and Applied Nutrition (HFS–810), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

301–436–1696. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 25, 

2007 (72 FR 34959), FDA published an 

IFR with a 90-day comment period to 

request comments on a procedure for a 

petition to request an exemption from 

100 percent identity testing of dietary 

ingredients. Comments on the 

exemption procedure will provide an 

opportunity for interested persons to 

comment on whether this exemption 

procedure should be modified, and if so, 

whether there is any additional 

information that may be helpful to 

articulate with respect to what a petition 

needs to show that may inform future 

guidance. 

The agency has received a request for 

a 60-day extension of the comment 

period for the IFR. The request 

conveyed concern that the current 90- 

day comment period does not allow 

sufficient time to develop a meaningful 

or thoughtful response to the IFR. 

FDA has considered the request and 

is extending the comment period for the 

IFR for 30 days, until October 24, 2007. 

The agency believes that a 30-day 

extension allows adequate time for 

interested persons to submit comments 

without significantly delaying 

rulemaking on these important issues. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments on this document. Submit a 

single copy of electronic comments or 

two paper copies of any mailed 

comments, except that individuals may 

submit one paper copy. Comments are 

to be identified with the docket number 

found in brackets in the heading of this 

document. Received comments may be 

seen in the Division of Dockets 

Management between 9 a.m. and 4 p.m., 

Monday through Friday. 

Dated: September 11, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–18293 Filed 9–14–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

25 CFR Part 900 

Contracts Under the SelfDetermination and Education 

Assistance Act; Change of Address for 

the Claims Branch 

AGENCY: Indian Health Service (IHS). 

ACTION: Final Rule; change of address. 

SUMMARY: The Indian Health Service is 

amending its regulations governing 

contracts under the Indian SelfDetermination and Education 

Assistance Act to reflect a change of 

address due to the relocation of the 

Claims Branch. 

DATES: This rule change is effective 

September 17, 2007. 

FOR FURTHER INFORMATION CONTACT: 

Hankie Ortiz, Acting Director, Division 

of Regulatory Affairs, IHS, 801 

Thompson Avenue, Twinbrook Metro 

Plaza, Suite 450, Rockville, Maryland 

20852, Telephone (301) 443–1116. 

SUPPLEMENTARY INFORMATION: 

I. Background 

Regulations promulgated by the IHS 

to govern the administration of contracts 

under the Indian Self-Determination 

and Education Assistance Act reference 

a mailing address for the Claims Branch. 

The Claims Branch has moved its office 

to a new location. This action provides 

the new mailing address for filing 

medical-related claims with the Claims 

Branch. 

mstockstill on PROD1PC66 with RULES

Federal Register / Vol. 72, No. 179 / Monday, September 17, 2007 / Rules and Regulations 52791 

II. Procedural Requirements 

A. Determination To Issue Final Rule 

Effective in Less than 30 Days 

IHS has determined that the public 

notice and comment provisions of the 

Administrative Procedure Act, 5 U.S.C. 

553(b) do not apply to this rulemaking. 

The changes being made relate solely to 

procedure and practice. The changes 

therefore, meet the requirements for 

exemption from notice and comment in 

5 U.S.C. 553(b)(A). 

B. Review Under Procedural Statutes 

and Executive Orders 

IHS has reviewed this rule under the 

following statutes and Executive Orders 

governing rulemaking procedures: The 

Unfunded Mandates Reform Act of 

1995, 2 U.S.C. 1501 et seq.; the 

Regulatory Flexibility Enforcement Act, 

5 U.S.C. 601 et seq.; the Small Business 

Regulatory Enforcement Fairness Act of 

1996, 5 U.S.C. 801 et seq.; the 

Paperwork Reduction Act, 4 U.S.C. 3501 

et seq.; Executive Order 12630 

(Takings); Executive Order 12866 

(Regulatory Planning and Review); 

Executive Order 12988 (Civil Justice 

Reform); Executive Order 13132 

(Federalism); Executive Order 13175 

(Tribal Consultation); and Executive 

Order 13211 (Energy Impacts). IHS has 

determined that this rule does not 

trigger any of the procedural 

requirements of those statutes and 

Executive Orders, since this rule is 

technical in nature and merely changes 

the mailing address for the Claims 

Branch. 

List of Subjects in 25 CFR Part 900 

Administrative practice and 

procedure, Buildings and facilities, 

Claims, Government contracts, 

Government property management, 

Grant programs—Indians, Health care, 

Indians, Indians—business and finance. 

■ For the reasons stated in the preamble, 

IHS amends its regulation in 25 CFR 

Part 900 as follows: 

PART 900—FEDERAL TORT CLAIMS 

ACT COVERAGE GENERAL 

PROVISIONS PROCEDURE FOR 

FILING MEDICAL-RELATED CLAIM 

■ 1. The authority citation for part 900 

continues to read as follows: 

Authority: 25 U.S.C. 450f et seq. 

§ 900.201 [Amended] 

■ 2. Section 900.201 is amended by 

removing ‘‘Chief, PHS Claims Branch, 

Room 18–20, Parklawn Building, 5600 

Fishers Lane, Rockville, MD 20857’’ and 

adding in its place Office of the General 

Counsel, General Law Division, Claims 

Office, 330 Independence Avenue, SW, 

Room 4256, Wilbur J. Cohen Federal 

Building, Washington, DC 20201.’’

Dated: September 5, 2007. 

Robert G. McSwain, 

Deputy Director, Indian Health Service. 

[FR Doc. 07–4585 Filed 9–14–07; 8:45 am] 

BILLING CODE 4165–16–M 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R09–OAR–2007–0276; FRL–8456–4] 

Revisions to the California State 

Implementation Plan, Mojave Desert 

Air Quality Management District 

AGENCY: Environmental Protection 

Agency (EPA). 

ACTION: Direct final rule. 

SUMMARY: EPA is taking direct final 

action to approve a revision to the 

Mojave Desert Air Quality Management 

District (MDAQMD) portion of the 

California State Implementation Plan 

(SIP). This revision concerns volatile 

organic compound (VOC) emissions 

from the usage of solvents. We are 

approving a local rule that regulates 

these emission sources under the Clean 

Air Act as amended in 1990 (CAA or the 

Act). 

DATES: This rule is effective on 

November 16, 2007 without further 

notice, unless EPA receives adverse 

comments by October 17, 2007. If we 

receive such comments, we will publish 

a timely withdrawal in the Federal 

Register to notify the public that this 

direct final rule will not take effect. 

ADDRESSES: Submit comments, 

identified by docket number RO9–OAR–

2007–0276, by one of the following 

methods: 

1. Federal eRulemaking Portal: 

www.regulations.gov. Follow the on-line 

instructions. 

2. E-mail: steckel.andrew@epa.gov. 

3. Mail or deliver: Andrew Steckel 

(Air-4), U.S. Environmental Protection 

Agency Region IX, 75 Hawthorne Street, 

San Francisco, CA 94105–3901. 

Instructions: All comments will be 

included in the public docket without 

change and may be made available 

online at www.regulations.gov, 

including any personal information 

provided, unless the comment includes 

Confidential Business Information (CBI) 

or other information whose disclosure is 

restricted by statute. Information that 

you consider CBI or otherwise protected 

should be clearly identified as such and 

should not be submitted through 

www.regulations.gov or e-mail. 

www.regulations.gov is an ‘‘anonymous 

access’’ system, and EPA will not know 

your identity or contact information 

unless you provide it in the body of 

your comment. If you send e-mail 

directly to EPA, your e-mail address 

will be automatically captured and 

included as part of the public comment. 

If EPA cannot read your comment due 

to technical difficulties and cannot 

contact you for clarification, EPA may 

not be able to consider your comment. 

Docket: The index to the docket for 

this action is available electronically at 

www.regulations.gov and in hard copy 

at EPA Region IX, 75 Hawthorne Street, 

San Francisco, California. While all 

documents in the docket are listed in 

the index, some information may be 

publicly available only at the hard copy 

location (e.g., copyrighted material), and 

some may not be publicly available in 

either location (e.g., CBI). To inspect the 

hard copy materials, please schedule an 

appointment during normal business 

hours with the contact listed in the FOR

FURTHER INFORMATION CONTACT section. 

FOR FURTHER INFORMATION CONTACT: 

Cynthia Allen, EPA Region IX, (415) 

947–4120, allen.cynthia@epa.gov. 

SUPPLEMENTARY INFORMATION: 

Throughout this document, ‘‘we,’’ ‘‘us’’

and ‘‘our’’ refer to EPA. 

Table of Contents 

I. The State’s Submittal 

A. What rule did the State submit? 

B. Are there other versions of this rule? 

C. What is the purpose of the submitted 

rule revisions? 

II. EPA’s Evaluation and Action 

A. How is EPA evaluating the rule? 

B. Does the rule meet the evaluation 

criteria? 

C. EPA Recommendations to Further 

Improve the Rule 

D. Public Comment and Final Action 

III. Statutory and Executive Order Reviews 

I. The State’s Submittal 

A. What rule did the State submit? 

Table 1 lists the rule we are approving 

with the date that the amended rule was 

adopted by the local air agency and 

submitted by the California Air 

Resources Board (CARB). 

mstockstill on PROD1PC66 with RULES