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 that 

FDA 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.—ESTIMATED ANNUAL REPORTING BURDEN1

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 

1There 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 

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

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 of 

the 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. 

mstockstill on DSKH9S0YB1PROD with NOTICES6