78716 Federal Register / Vol. 75, No. 241 / Thursday, December 16, 2010 / Notices 

1We note that the American Herbal Products 

Association submitted a petition for reconsideration 

on July 25, 2007, under 21 CFR 10.33, requesting 

reconsideration of certain provisions of the DS 

CGMP final rule. FDA is currently considering this 

petition and the SECG does not represent a 

response to such petition. 

Supplements—Small Entity Compliance 

Guide.’’ The small entity compliance 

guide (SECG) is being issued for a final 

rule and an interim final rule published 

in the Federal Register of June 25, 2007, 

and is intended to set forth in plain 

language the requirements of that final 

rule and interim final rule and to help 

small businesses understand the 

regulations. In addition, the SECG 

includes several recommendations 

made by FDA in that final rule so that 

the guidance in those recommendations 

will be readily accessible to small 

businesses. 

DATES: Submit either electronic or 

written comments on the SECG at any 

time. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

comments on the SECG to the Division 

of Dockets Management (HFA–305), 

Food and Drug Administration, 5630 

Fishers Lane, Rm. 1061, Rockville, MD 

20852. Submit written requests for 

single copies of the SECG to the 

Division of Dietary Supplement 

Programs (HFS–810), Office of 

Nutrition, Labeling, and Dietary 

Supplements, Center for Food Safety 

and Applied Nutrition, Food and Drug 

Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740. Send 

two self-addressed adhesive labels to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the SECG. 

FOR FURTHER INFORMATION CONTACT: 

Bradford Williams, Center for Food 

Safety and Applied Nutrition (HFS– 

810), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 301–436–1440. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of June 25, 

2007 (72 FR 34752), FDA issued a final 

rule establishing current good 

manufacturing practice (CGMP) 

regulations for dietary supplements (21 

CFR part 111) (the DS CGMP final rule). 

The DS CGMP final rule requires 

persons who manufacture, package, 

label, or hold a dietary supplement to 

establish and follow current good 

manufacturing practice to ensure the 

quality of the dietary supplement and to 

ensure that the dietary supplement is 

packaged and labeled as specified in the 

master manufacturing record. In that 

same issue of the Federal Register (72 

FR 34959), FDA also issued an interim 

final rule (the identity testing interim 

final rule) that sets forth a procedure for 

requesting an exemption from a 

requirement for the manufacturer to 

conduct at least one appropriate test or 

examination to verify the identity of any 

dietary ingredient that is a component 

of a dietary supplement. The final rule 

and the identity testing interim final 

rule became effective August 24, 2007. 

The compliance date of the DS CGMP 

final rule and the identity testing 

interim final rule is June 25, 2008; 

except that for businesses employing 

fewer than 500, but 20 or more full-time 

equivalent employees, the compliance 

date is June 25, 2009; and except that for 

businesses that employ fewer than 20 

full-time equivalent employees, the 

compliance date is June 25, 2010. 

FDA examined the economic 

implications of the DS CGMP final rule 

as required by the Regulatory Flexibility 

Act (5 U.S.C. 601–612) and determined 

that the DS CGMP final rule would have 

a significant economic impact on a 

substantial number of small entities. In 

compliance with section 212 of the 

Small Business Regulatory Enforcement 

Fairness Act (Public Law 104–121), FDA 

is making available this SECG stating in 

plain language the requirements of the 

regulations. We also examined the 

economic implications of the identity 

testing interim final rule as required by 

the Regulatory Flexibility Act and 

determined that the identity testing 

interim final rule would not have a 

significant economic impact on a 

substantial number of small entities. 

However, because the identity testing 

interim final rule revises the DS CGMP 

final rule, the SECG includes the 

provisions of the identity testing interim 

final rule. 

FDA is issuing this SECG as level 2 

guidance consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115(c)(2)).1 The SECG restates, in 

simplified format and language, FDA’s 

requirements for Current Good 

Manufacturing Practice in 

Manufacturing, Packaging, Labeling, or 

Holding Operations for Dietary 

Supplements, including the 

requirements for a Petition to Request 

an Exemption from 100 Percent Identity 

Testing of Dietary Ingredients. In 

addition, the SECG includes several 

recommendations made by FDA in the 

DS CGMP rule so that the guidance in 

those recommendations will be readily 

accessible to small businesses. 

The SECG represents FDA’s current 

thinking on current good manufacturing 

practice in manufacturing, packaging, 

labeling, or holding operations for 

dietary supplements. It does not create 

or confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statutes 

and regulations. We note, however, that 

the regulations that serve as the basis for 

this guidance document establish 

requirements for all covered activities. 

For this reason, we recommend that 

affected parties consult the regulations 

at 21 CFR part 111 in addition to 

reading the SECG. 

II. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information are subject to 

review by the Office of Management and 

Budget (OMB) under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3520). The collections of information in 

21 CFR part 111 have been approved 

under 0910–0606. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments on the SECG. It is only 

necessary to send one set of comments. 

It is no longer necessary to send two 

copies of mailed comments. Identify 

comments 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. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the SECG at http:// 

www.fda.gov/FoodGuidances.html or 

http://www.regulations.gov. 

Dated: December 13, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31613 Filed 12–15–10; 8:45 am] 

BILLING CODE 4160–01–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. 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 75, No. 241 / Thursday, December 16, 2010 / Notices 78717 

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. Member 

Conflict: Renal Disease. 

Date: January 7, 2011. 

Time: 2 p.m. to 5 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: Ryan G. Morris, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4205, 

MSC 7814, Bethesda, MD 20892. 301–435– 

1501. morrisr@csr.nih.gov. 

Name of Committee: Center for Scientific 

Review Special Emphasis Panel. Member 

Conflict: BGES Member. 

Date: January 14, 2011. 

Time: 1:30 p.m. to 2:30 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: J Scott Osborne, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4114, 

MSC 7816, Bethesda, MD 20892. (301) 435– 

1782. osbornes@csr.nih.gov. 

Name of Committee: Oncology 1—Basic 

Translational Integrated Review Group. 

Cancer Etiology Study Section. 

Date: January 18, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Washington Marriott Wardman Park, 

2660 Woodley Road, NW., Washington, DC 

20008. 

Contact Person: Elaine Sierra-Rivera, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6184, 

MSC 7804, Bethesda, MD 20892, 301–435– 

1779. riverase@csr.nih.gov. 

Name of Committee: Biological Chemistry 

and Macromolecular Biophysics Integrated 

Review Group. Biochemistry and Biophysics 

of Membranes Study Section. 

Date: January 26–27, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Renaissance Mayflower Hotel, 1127 

Connecticut Avenue, NW., Washington, DC 

20036. 

Contact Person: Nuria E. Assa-Munt, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 4164, 

MSC 7806, Bethesda, MD 20892. (301) 451– 

1323. assamunu@csr.nih.gov. 

Name of Committee: Digestive, Kidney and 

Urological Systems Integrated Review Group. 

Hepatobiliary Pathophysiology Study 

Section. 

Date: January 31–February 1, 2011. 

Time: 8 a.m.to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, 7400 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Rass M. Shayiq, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 2182, 

MSC 7818, Bethesda, MD 20892. (301) 435– 

2359. shayiqr@csr.nih.gov. 

Name of Committee: Oncology 2— 

Translational Clinical Integrated Review 

Group. Basic Mechanisms of Cancer 

Therapeutics Study Section. 

Date: January 31–February 1, 2011. 

Time: 8 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Ritz Carlton Hotel, 1150 22nd Street, 

NW., Washington, DC 20037. 

Contact Person: Lambratu Rahman, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 6214, 

MSC 7804, Bethesda, MD 20892. 301–451– 

3493. rahmanl@csr.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.306, Comparative Medicine; 

93.333, Clinical Research, 93.306, 93.333, 

93.337, 93.393–93.396, 93.837–93.844, 

93.846–93.878, 93.892, 93.893, National 

Institutes of Health, HHS) 

Dated: December 10, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–31594 Filed 12–15–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; 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: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; Central Repositories 

Non-Renewable Sample Access (PAR–10– 

90)–Type 1 Diabetes. 

Date: January 24, 2011. 

Time: 2 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892. (Telephone 

Conference Call). 

Contact Person: Najma Begum, PhD, 

Scientific Review Officer, Review Branch, 

Dea, Niddk, National Institutes of Health, 

Room 749, 6707 Democracy Boulevard, 

Bethesda, Md 20892–5452. (301) 594–8894. 

begumn@niddk.nih.gov. 

Name of Committee: National Institute of 

Diabetes and Digestive and Kidney Diseases 

Special Emphasis Panel; PO1 Vascular 

Complications in Diabetes. 

Date: January 25, 2011. 

Time: 2 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, Two 

Democracy Plaza, 6707 Democracy 

Boulevard, Bethesda, MD 20892. (Telephone 

Conference Call). 

Contact Person: D.G. Patel, PhD, Scientific 

Review Officer, Review Branch, Dea, Niddk, 

National Institutes of Health, Room 756, 6707 

Democracy Boulevard, Bethesda, Md 20892– 

5452. (301) 594–7682. 

pateldg@niddk.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.847, Diabetes, 

Endocrinology and Metabolic Research; 

93.848, Digestive Diseases and Nutrition 

Research; 93.849, Kidney Diseases, Urology 

and Hematology Research, National Institutes 

of Health, HHS) 

Dated: December 10, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–31607 Filed 12–15–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Eunice Kennedy Shriver National 

Institute of Child Health and Human 

Development; Notice of Closed 

Meeting 

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 meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 


srobinson on DSKHWCL6B1PROD with NOTICES