61782 Federal Register / Vol. 71, No. 202 / Thursday, October 19, 2006 / Notices 

manufacturer must report either 

electronically or by mail using Form 

FDA–3486, a standardized reporting 

format. Examples of reportable and 

nonreportable events concerning the 

incoming material specifications, 

process controls, product specifications, 

product testing, product labeling, 

quality control procedures, and product 

distribution are discussed. These 

examples may not apply to all 

establishments because they include 

deviations and unexpected events 

related to standard operating procedures 

implemented at individual 

establishments and may not be an 

industry standard or a procedure at your 

facility. The guidance also contains a 

Biological Product Deviation Reporting 

Flowchart to aid in determining if an 

event is reportable. 

In the Federal Register of August 13, 

2001 (66 FR 42547), FDA announced the 

availability of the draft guidance of the 

same title. FDA received several 

comments on the draft guidance and 

those comments were considered as the 

guidance was finalized. Editorial 

changes were made to improve clarity. 

The guidance announced in this notice 

finalizes the draft guidance dated 

August 2001. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

This guidance represents the FDA’s 

current thinking on this topic. 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 requirement of the 

applicable statutes and regulations. 

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 collection of information 

under § 600.14 was approved under 

OMB control number 0910–0458. The 

collections of information under 21 CFR 

606.100 and 606.171 were approved 

under OMB control number 0910–0116. 

The collections of information under 21 

CFR 820.90 and 820.100 were approved 

under OMB control number 0910–0139, 

and the collections of information under 

21 CFR 211.192 and 211.198 were 

approved under OMB control number 

0910–0073. 

III. Comments 

Interested persons may, at any time, 

submit written or electronic comments 

to the Division of Dockets Management 

(see ADDRESSES) regarding this 

guidance. 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 the 

brackets in the heading of this 

document. A copy of the guidance and 

received comments are available for 

public examination 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 guidance at either http:// 

www.fda.gov/cber/guidelines.htm or 

http://www.fda.gov/ohrms/dockets/ 

default.htm. 

Dated: October 10, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E6–17374 Filed 10–18–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in section 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 Human 

Genome Research Institute Special Emphasis 

Panel, Resources and Training Review 

Teleconference. 

Date: November 8, 2006. 

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

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 5635 

Fishers Lane, Bethesda, MD 20892. 

Contact Person: Keith McKenney, PhD, 

Scientific Review Administrator, NHGRI, 

5635 Fishers Lane, Suite 4076, Bethesda, MD 

20814. 301–594–4280, 

mckenneyk@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.172, Human Genome 

Research, National Institutes of Health, HHS) 

Dated: October 10, 2006. 

Linda Payne, 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 06–8777 Filed 10–18–06; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Diabetes and 

Digestive and Kidney Diseases; Notice 

of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), 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 

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, Conference Grants 

Review. 

Date: October 20, 2006. 

Time: 1 p.m. to 3 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: Atul Sahai, PhD, Scientific 

Review Administrator, Review Branch, DEA, 

NIDDK, National Institutes of Health, Room 

908, 6707 Democracy Boulevard, Bethesda, 

MD 20892–5452, 301–594–2242, 

sahaia@niddk.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. 

(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) 


cprice-sewell on PROD1PC66 with NOTICES
Federal Register / Vol. 71, No. 202 / Thursday, October 19, 2006 / Notices 61783 

Dated: October 10, 2006. 

Linda Payne, 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 06–8772 Filed 10–18–06; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Neurological 

Disorders and Stroke; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), notice 

is hereby given of the following 

meetings. 

The meeting 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 

Neurological Disorders and Stroke Special 

Emphasis Panel, Glioma Therapies SEP. 

Date: November 3, 2006. 

Time: 11 a.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Telephone 

Conference Call). 

Contact Person: Shantadurga Rajaram, 

PhD, Scientific Review Administrator, 

Scientific Review Branch, NIH/NINDS/ 

Neuroscience Center, 6001 Executive Blvd., 

Suite 3208, MSC 9529, Bethesda, MD 20852, 

301–435–6033, rajarams@mail.nih.gov. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel, Epilepsy Studies SEP. 

Date: November 6, 2006. 

Time: 2:30 p.m. to 4:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Telephone 

Conference Call). 

Contact Person: Shantadurga Rajaram, 

PhD, Scientific Review Administrator, 

Scientific Review Branch, NIH/NINDS/ 

Neuroscience Center, 6001 Executive Blvd., 

Suite 3208, MSC 9529, Bethesda, MD 20852, 

301–435–6033, rajarams@mail.nih.gov. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel, K99/R00 REVIEW. 

Date: November 15, 2006. 

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

Agenda: To review and evaluate grant 

applications. 

Place: The Fairmont Washington, DC., 

2401 M Street, NW., Washington, DC 20037. 

Contact Person: JoAnn McConnell, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, NIH/NINDS/Neuroscience 

Center, 6001 Executive Blvd., Suite 3208, 

MSC 9529, Bethesda, MD 20892–9529, 301–

496–5324, mcconnej@ninds.nih.gov. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel, NINDS Roadmap HTS Assay 

Development. 

Date: November 16–17, 2006. 

Time: 8 a.m. to 6 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: The Watergate Hotel, 2650 Virginia 

Ave., NW., Monticello, Washington, DC 

20037. 

Contact Person: Shantadurga Rajaram, 

PhD, Scientific Review Administrator, 

Scientific Review Branch, NIH/NINDS/ 

Neuroscience Center, 6001 Executive Blvd., 

Suite 3208, MSC 9529, Bethesda, MD 20852, 

301–435–6033, rajarams@mail.nih.gov. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel, Fellowship Review. 

Date: November 17, 2006. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Topaz Hotel, 1733 N Street, NW., 

Washington, DC 20036. 

Contact Person: JoAnn McConnell, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, NIH/NINDS/Neuroscience 

Center, 6001 Executive Blvd., Suite 3208, 

MSC 9529, Bethesda, MD 20892–9529, 301–

496–5324, mcconnell@ninds.nih.gov. 

Name of Committee: National Institute of 

Neurological Disorders and Stroke Special 

Emphasis Panel, Mechanisms of Epilepsy. 

Date: November 28, 2006. 

Time: 1 p.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Neuroscience Center, 6001 Executive 

Boulevard, Rockville, MD 20852 (Telephone 

Conference Call). 

Contact Person: Shantadurga Rajaram, 

PhD, Scientific Review Administrator, 

Scientific Review Branch, NIH/NINDS/ 

Neuroscience Center, 6001 Executive Blvd., 

Suite 3208, MSC 9529, Bethesda, MD 20852, 

301–435–6033, rajarams@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.853, Clinical Research 

Related to Neurological Disorders; 93.854, 

Biological Basis Research in the 

Neurosciences, National Institutes of Health, 

HHS) 

Dated: October 10, 2006. 

Linda Payne, 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 06–8773 Filed 10–18–06; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Child Health and 

Human Development; Notice of Closed 

Meetings 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. Appendix 2), 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 

Child Health and Human Development 

Special Emphasis Panel, Mechanisms of 

Preeclampsia; Impact of Obesity. 

Date: October 25, 2006. 

Time: 1 p.m. to 4 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6100 

Executive Boulevard, Room 5B01, Rockville, 

MD 20852 (Telephone Conference Call). 

Contact Person: Gopal M. Bhatnagar, PhD, 

Scientific Review Administrator, National 

Institutes of Health, 6100 Bldg Rm 5B01, 

Rockville, MD 20852, 301–435–6889. 

bhatnagg@mail.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: National Institute of 

Child Health and Human Development 

Special Emphasis Panel, Health, Behavior, 

and Context Subcommittee. 

Date: October 26–27, 2006. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Bethesda Marriott Suites, 6711 

Democracy Boulevard, Bethesda, MD 20817. 

Contact Person: Michele C. HindiAlexander, PhD, Division of Scientific 

Review, National Institutes of Health, 

National Institute for Child Health, and 

Human Development, 6100 Executive 

Boulevard, Room 5B01, Bethesda, MD 

20812–7510, 301–435–8382. 

hindialm@mail.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. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.864, Population Research; 


cprice-sewell on PROD1PC66 with NOTICES