Federal Register / Vol. 74, No. 73 / Friday, April 17, 2009 / Notices 17873 

industry entitled ‘‘Submission of 

Summary Bioequivalence Data for 

ANDAs.’’ The draft guidance is 

intended to assist abbreviated new drug 

application (ANDA) applicants in 

complying with the new requirements 

in the final rule on the submission of 

bioequivalence data published in the 

Federal Register in January 2009. The 

final rule requires ANDA applicants to 

submit data from all bioequivalence 

studies (BE studies) the applicant 

conducts on a drug product formulation 

submitted for approval, including both 

studies that demonstrate and studies 

that fail to demonstrate that a generic 

product meets the current 

bioequivalence criteria. The draft 

guidance provides recommendations to 

applicants planning to include BE 

studies for submission in ANDAs, and 

is applicable to BE studies conducted 

during both preapproval and 

postapproval periods. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the agency 

considers your comments on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

written or electronic comments on the 

draft guidance by July 16, 2009. 

ADDRESSES: Submit written requests for 

single copies of this draft guidance to 

the Division of Drug Information, Center 

for Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 2201, 

Silver Spring, MD 20993–0002. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. Submit written comments on 

the draft guidance to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments to http:// 

www.regulations.gov. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Aida L. Sanchez, Center for Drug 

Evaluation and Research (HFD–650), 

Food and Drug Administration, 5600 

Fishers Lane, Rockville, MD 20857, 

301–827–5847. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of October 29, 

2003 (68 FR 61640), FDA published a 

proposed rule to require an ANDA 

applicant to submit data from all BE 

studies that the applicant conducts on a 

drug product formulation submitted for 

approval. The agency’s final rule 

amending its bioequivalence regulations 

was published in the Federal Register 

on January 16, 2009 (74 FR 2849). All 

BE studies conducted on the same drug 

product formulation, including studies 

that demonstrate and studies that fail to 

demonstrate that a generic product 

meets the current bioequivalence 

criteria, must be submitted to the 

agency. Information from all BE studies 

is important to the agency for the 

following reasons: 

• Data contained in any BE study 

could be important to FDA’s assessment 

of bioequivalence for a specific product; 

and 

• Even when additional BE studies 

are not critical to the agency’s 

bioequivalence determination for the 

specific product being reviewed, the 

data provide valuable scientific 

information that increases the agency’s 

knowledge and understanding of 

bioequivalence and generic drug 

development and promotes further 

development of science-based 

bioequivalence policies. 

II. The Draft Guidance 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Submission of Summary 

Bioequivalence Data for ANDAs.’’ The 

draft guidance provides 

recommendations to applicants 

planning to include BE studies for 

submission in ANDAs. The draft 

guidance provides information on the 

following subjects: 

• The types of ANDA submissions 

covered by the new regulations on BE 

studies; 

• A recommended format for 

summary reports of BE studies; and 

• What formulations FDA considers 

the ‘‘same drug product formulation’’ 

for different dosage forms based on 

differences in composition. 

The draft guidance is applicable to BE 

studies conducted for ANDAs during 

both preapproval and postapproval 

periods. 

The draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on summary bioequivalence data reports 

to be submitted in ANDAs. 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. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding the draft 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 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. Paperwork Reduction Act of 1995 

The draft guidance refers to 

information collection provisions that 

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 314.94(a)(7), 

314.96(a)(1), and 314.97 have been 

approved under OMB control number 

0910–0630. 

V. Electronic Access 

Persons with access to the Internet 

may obtain the document at either 

http://www.fda.gov/cder/guidance/ 

index.htm or http:// 

www.regulations.gov. 

Dated: April 9, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–8833 Filed 4–16–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Nursing Research; 

Notice of Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended (5 U.S.C. App.), notice is 

hereby given of a meeting of the 

National Advisory Council for Nursing 

Research. 

The meeting will be open to the 

public as indicated below, 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. 

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, 

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17874 Federal Register / Vol. 74, No. 73 / Friday, April 17, 2009 / Notices 

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 Advisory 

Council for Nursing Research. 

Date: May 19–20, 2009. 

Open: May 19, 2009, 1 p.m. to 

Adjournment. 

Agenda: Discussion of Program Policies 

and Issues. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 6C, Room 6, Bethesda, MD 20892. 

Closed: May 20, 2009, 9 a.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Building 31, 31 Center Drive, Conference 

Room 6C, Room 6, Bethesda, MD 20892. 

Contact Person: Mary E. Kerr, FAAN, RN, 

PhD, Deputy Director, National Institute of 

Nursing, National Institutes of Health, 31 

Center Drive, Room 5B–05, Bethesda, MD 

20892–2178. 301/496–8230. 

kerrme@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. 

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. 

Information is also available on the 

Institute’s/Center’s home page: http:// 

www.nih.gov/ninr/a_advisory.html, where an 

agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.361, Nursing Research, 

National Institutes of Health, HHS) 

Dated: April 10, 2009. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–8899 Filed 4–16–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

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 

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 

Mental Health Special Emphasis Panel, 

NIMH/ARMY RFA Project. 

Date: May 1, 2009. 

Time: 2 p.m. to 6 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: David I. Sommers, PhD, 

Scientific Review Officer, Division of 

Extramural Activities, National Institute of 

Mental Health, National Institutes of Health, 

6001 Executive Blvd., Room 6154, MSC 9606, 

Bethesda, MD 20892–9606, 301–443–7861, 

dsommers@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.242, Mental Health Research 

Grants; 93.281, Scientist Development 

Award, Scientist Development Award for 

Clinicians, and Research Scientist Award; 

93.282, Mental Health National Research 

Service Awards for Research Training, 

National Institutes of Health, HHS) 

Dated: April 10, 2009. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–8892 Filed 4–16–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Mental Health; 

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 

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 

Mental Health Special Emphasis Panel. 

Biobehavioral Research Awards for 

Innovative New Sciences. 

Date: May 14, 2009. 

Time: 9 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Melrose Hotel, 2430 Pennsylvania 

Ave., NW., Washington, DC 20037. 

Contact Person: Megan Libbey, PhD, 

Scientific Review Officer, Division of 

Extramural Activities, National Institute of 

Mental Health, NIH, Neuroscience Center, 

6001 Executive Blvd., Room 6148, MSC 9609, 

Rockville, MD 20852–9609. 301–402–6807. 

libbeym@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.242, Mental Health Research 

Grants; 93.281, Scientist Development 

Award, Scientist Development Award for 

Clinicians, and Research Scientist Award; 

93.282, Mental Health National Research 

Service Awards for Research Training, 

National Institutes of Health, HHS) 

Dated: April 13, 2009. 

Anna Snouffer, 

Deputy Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. E9–8891 Filed 4–16–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Centers for Disease Control and 

Prevention (CDC) 

Board of Scientific Counselors, 

Coordinating Office for Terrorism 

Preparedness and Emergency 

Response (BSC, COTPER) 

Correction: This notice was published 

in the Federal Register on March 20, 

2009, Volume 74, Number 53, Page 

11958. The time and date, place, status, 

and matters to be discussed for the 

aforementioned meeting have been 

changed to the following: 

Time and Date: 2 p.m.–4:30 p.m., 

April 27, 2009. 

Place: Web Conference. Please contact 

the BSC Coordinator (see Contact Person 

for More Information) to obtain further 

instructions on how to participate by 

phone and online. Members of the 

public may also attend this meeting in 

person at CDC, 1600 Clifton Road, NE., 

Global Communications Center, 

Building 19, Room 245/246, Atlanta, 

Georgia 30333. 

Status: This Web conference will be 

open to the public, limited only by the 

public meeting space available for 

individuals participating in person. The 

public meeting room accommodates 

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