### 60464 Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Notices

collection of information to OMB for review and clearance.

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—(OMB Control Number 0910–0608)—Extension

On October 25, 1994, the Dietary Supplement Health and Education Act (DSHEA) (Public Law 103–417) was signed into law. DSHEA, among other things, amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding section 402(g) of the FD&C Act (21 U.S.C. 342(g)). Section 402(g)(2) of the FD&C Act provides, in part, that the Secretary of Health and Human Services (the Secretary) may, by regulation, prescribe good manufacturing practices for dietary supplements. Section 402(g)(1) of the FD&C Act states that a dietary supplement is adulterated if ‘‘it has been prepared, packed, or held under conditions that do not meet current good manufacturing practice regulations. ’’ Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA may issue regulations necessary for the efficient enforcement of the FD&C Act.

FDA published a final rule on June 25, 2007 (72 FR 34752) (the final rule) that established, in part 111 (21 CFR part 111), the minimum Current Good Manufacturing Practice (CGMP) necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. On June 25, 2007 (72 FR 34959), FDA also published an Interim Final Rule (the IFR) establishing a procedure for a petition to request an exemption from 100 percent identity testing of dietary ingredients. The IFR redesignated § 111.75(a)(1) of the CGMP final rule as § 111.75(a)(1)(i) and set forth a procedure for submission of a petition to FDA in a new § 111.75(a)(1)(ii), under which manufacturers may request an exemption from the requirements set forth in § 111.75(a)(1)(i) when the dietary ingredient is obtained from one or more suppliers identified in the petition. The regulation clarifies thatFDA is willing to consider, on a case-bycase basis, a manufacturer’s conclusion, supported by appropriate data and information in the petition submission, that it has developed a system that it would implement as a sound, consistent means of establishing, with no material diminution of assurance compared to the assurance provided by 100 percent identity testing, the identity of the dietary ingredient before use.

Section 111.75(a)(1) of the CGMP final rule reflects FDA’s determination that manufacturers that test or examine 100 percent of the incoming dietary ingredients for identity can be assured of the identity of the ingredient. However, FDA recognizes that it may be possible for a manufacturer to demonstrate, through various methods and processes in use over time for its particular operation, that a system of less than 100 percent identity testing would result in no material diminution of assurance of the identity of the dietary ingredient as compared to the assurance provided by 100 percent identity testing. To provide an opportunity for a manufacturer to make such a showing and reduce the frequency of identity testing of components that are dietary ingredients from 100 percent to some lower frequency, FDA added to § 111.75(a)(1), an exemption from the requirement of 100 percent identity testing when a manufacturer petitions the agency for such an exemption to 100 percent identity testing under § 10.30 and the agency grants such exemption. Such a procedure would be consistent with FDA’s stated goal, as described in the CGMP final rule, of providing flexibility in the CGMP requirements. Section 111.75(a)(1)(ii) sets forth the information a manufacturer is required to submit in such a petition. The regulation also contains a requirement to ensure that the manufacturer keeps the FDA’s response to a petition submitted under § 111.75(a)(1)(ii) as a record under § 111.95. The collection of information in § 111.95 has been approved under OMB control number

0910–0606.

Description of Respondents : The respondents to this collection of information are firms in the dietary supplement industry, including dietary supplement manufacturers, packagers and re-packagers, holders, labelers and re-labelers, distributors, warehouses, exporters, importers, large businesses, and small businesses.

In the Federal Register of July 20, 2010 (75 FR 42095) FDA published a 60- day notice requesting public comment on the proposed collection of information. No comments were received.

FDA estimates the burden of this collection of information as follows:



### TABLE 

### 1.—E STIMATED 

### A NNUAL 

### R EPORTING 

### B URDEN 1

21 CFR Section Number of Respondents Annual Frequency per Response Total Annual Responses Hours per Response Total Hours

111.75(a)(1)(ii) 1 1 1 8 8

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

In the last 3 years, FDA has not received any new petitions to request an exemption from 100 percent identity testing of dietary ingredients; therefore, the agency estimates that one or fewer petitions will be submitted annually. Although FDA has not received any new petitions to request an exemption from 100 percent identity testing of dietary ingredients in the last 3 years, it
believes that these information collection provisions should be extended to provide for the potential future need of a firm in the dietary supplement industry to petition for an exemption from 100 percent identity testing of dietary ingredients. Based on our experience with petition processes, we estimate that the assembly of information in support of the petition required by § 111.75(a)(1)(ii) will take 8
hours.

Dated: September 27, 2010.

Leslie Kux, Acting Assistant Commissioner for Policy.

[FR Doc. 2010–24642 Filed 9–29–10; 8:45 am]

**BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND**  **HUMAN SERVICES**

**Agency for Healthcare Research and Quality** 

**Notice of Meeting**

In accordance with section 10(d) of the Federal Advisory Committee Act (5 U.S.C., Appendix 2), announcement is made of a Health Care Policy and Research Special Emphasis Panel (SEP) meeting.

A Special Emphasis Panel is a group of experts in fields related to health care


### 60465 Federal Register / Vol. 75, No. 189 / Thursday, September 30, 2010 / Notices

research who are invited by the Agency for Healthcare Research and Quality (AHRQ), and agree to be available, to conduct on an as needed basis, scientific reviews of applications for AHRQ support. Individual members ofthe Panel do not attend regularlyscheduled meetings and do not serve for fixed terms or a long period of time. Rather, they are asked to participate in particular review meetings which require their type of expertise.

Substantial segments of the upcoming SEP meeting listed below will be closed to the public in accordance with the Federal Advisory Committee Act, section 10(d) of 5 U.S.C., Appendix 2 and 5 U.S.C. 552b(c)(6). Grant applications for the Advancing Patient Safety with Simulation Research Mechanism (R18) applications are to be reviewed and discussed at this meeting. These discussions are likely to reveal personal information concerning
individuals associated with the applications. This information is exempt from mandatory disclosure
under the above-cited statutes.

SEP Meeting on: Advancing Patient Safety with Simulation Research Mechanism (R18).

Date: November 18–19, 2010 (Open
on November 18 from 8:30 a.m. to 8:45
a.m. and closed for the remainder of the meeting).

Place: Hilton Washington DC/ Rockville Hotel &; Executive Meeting Center, 1750 Rockville Pike, Conference Room TBD, Rockville, MD 20852.

Contact Person: Anyone wishing to obtain a roster of members, agenda or minutes of the nonconfidential portions of this meeting should contact Mrs. Bonnie Campbell, Committee Management Officer, Office of Extramural Research, Education and Priority Populations, AHRQ, 540 Gaither Road, Room 2038, Rockville, Maryland 20850, Telephone (301) 427–

1554.

Agenda items for this meeting are subject to change as priorities dictate.

Dated: September 17, 2010.
Carolyn M. Clancy,

Director.

[FR Doc. 2010–24443 Filed 9–29–10; 8:45 am]

**BILLING CODE 4160–90–M DEPARTMENT OF HEALTH AND**  **HUMAN SERVICES**

**National Institutes of Health**

**Division of Program Coordination, Planning, and Strategic Initiatives,**  **Office of the Director, National Institutes of Health; Notice of Meeting** 

Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Council of Councils.

The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.

Name of Committee: Council of Councils.

Date: November 8, 2010.

Time: 9 a.m. to 3 p.m. Agenda: Among the topics proposed for discussion are current and completed Common Fund programs and the role of the Council of Councils in concept review.

Place: National Institutes of Health, Building 31, 31 Center Drive, Conference Room 6, Bethesda, MD 20892.

Contact Person: Robin Kawazoe, Executive Secretary, Division of Program Coordination, Planning, and Strategic Initiatives, Office of the Director, NIH, Building 1, Room 260B, Bethesda, MD 20892. kawazoer@mail.nih.gov

.

Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person. Information is also available on the Council of Council’s home page at http:// dpcpsi.nih.gov/council/, where an agenda and proposals to be discussed will be posted before the meeting date.

In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver’s license, or passport) and to state the purpose of their
visit. (Catalogue of Federal Domestic Assistance Program Nos. 93.14, Intramural Research Training Award; 93.22, Clinical Research Loan Repayment Program for Individuals from Disadvantaged Backgrounds; 93.232, Loan Repayment Program for Research Generally; 93.39, Academic Research Enhancement Award; 93.936, NIH Acquired Immunodeficiency Syndrome Research Loan Repayment Program; 93.187, Undergraduate Scholarship Program for Individuals from Disadvantaged Backgrounds, National Institutes of Health, HHS) Dated: September 23, 2010. Jennifer S. Spaeth, Director, Office of Federal Advisory Committee Policy.

[FR Doc. 2010–24548 Filed 9–29–10; 8:45 am]

**BILLING CODE 4140–01–P**

**DEPARTMENT OF HEALTH AND HUMAN SERVICES** 

**National Institutes of Health**

**Center for Scientific Review; Notice of Closed Meetings** 

Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.

The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.

Name of Committee: Center for Scientific Review Special Emphasis Panel, PA10–067: Psychological and Brain Sciences.

Date: October 12, 2010.
Time: 1 p.m. to 2 p.m. Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Telephone Conference Call)

Contact Person: Anna L. Riley, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3114, MSC 7759, Bethesda, MD 20892. 301–435–

2889. rileyann@csr.nih.gov.

This notice is being published less than 15 days prior to the meeting due to the timing limitations imposed by the review and funding cycle.

Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict: Language and Communication.

Date: October 20–21, 2010.

Time: 8 a.m. to 5 p.m. Agenda: To review and evaluate grant applications.

Place: National Institutes of Health, 6701 Rockledge Drive, Bethesda, MD 20892. (Virtual Meeting.)

Contact Person: Maribeth Champoux, PhD, Scientific Review Officer, Center for Scientific Review, National Institutes of Health, 6701 Rockledge Drive, Room 3170, MSC 7848, Bethesda, MD 20892. 301–594–

3163. champoum@csr.nih.gov.

Name of Committee: Center for Scientific Review Special Emphasis Panel, Member Conflict: Vascular and Hematology Member Conflict.