64310 Federal Register / Vol. 75, No. 201 / Tuesday, October 19, 2010 / Notices 

DATES: Public Comment Period: 

Comments must be received by 

December 20, 2010. 

ADDRESSES: Written comments may be 

submitted to the NIOSH Docket Office, 

identified by Docket Number NIOSH– 

220, by any of the following methods: 

• Mail: NIOSH Docket Office, Robert 

A. Taft Laboratories, MS–C34, 4676 

Columbia Parkway, Cincinnati, Ohio 

45226. 

• Facsimile: (513) 533–8285. 

• E-mail: nioshdocket@cdc.gov. 

All information received in response 

to this notice will be available for public 

examination and copying at the NIOSH 

Docket Office, 4676 Columbia Parkway, 

Room 111, Cincinnati, Ohio 45226. A 

complete electronic docket containing 

all comments submitted will be 

available on the NIOSH web page at 

http://www.cdc.gov/niosh/docket, and 

comments will be available in writing 

by request. NIOSH includes all 

comments received without change in 

the docket, including any personal 

information provided. All electronic 

comments should be formatted as 

Microsoft Word. Please make reference 

to Docket Number NIOSH–220. 

FOR FURTHER INFORMATION CONTACT: 

Stanley A. Shulman, PhD., telephone 

(513) 841–4258, e-mail mailto: 

sas2@cdc.gov, or Amy Feng, M.S., 

telephone (513) 841–4128, e-mail 

haf0@cdc.gov, NIOSH, MS–R3, 4676 

Columbia Parkway, Cincinnati, OH 

45226. 

John Howard, 

Director, National Institute for Occupational 

Safety and Health, Centers for Disease Control 

and Prevention. 

[FR Doc. 2010–26221 Filed 10–18–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–P–0234] 

Determination That BUSPAR 

(Buspirone Hydrochloride) Tablets, 10 

Milligrams, 15 Milligrams, and 30 

Milligrams, Were Not Withdrawn From 

Sale for Reasons of Safety or 

Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

that BUSPAR (buspirone hydrochloride) 

Tablets, 10 milligrams (mg), 15 mg, and 

30 mg, were not withdrawn from sale 

for reasons of safety or effectiveness. 

This determination means that FDA will 

not begin procedures to withdraw 

approval of abbreviated new drug 

applications (ANDAs) that refer to this 

drug product, and it will allow FDA to 

continue to approve ANDAs that refer to 

the product as long as they meet 

relevant legal and regulatory 

requirements. 

FOR FURTHER INFORMATION CONTACT: 

Molly Flannery, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6237, 

Silver Spring, MD 20993–0002, 301– 

796–3543. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products approved 

under an ANDA procedure. ANDA 

applicants must, with certain 

exceptions, show that the drug for 

which they are seeking approval 

contains the same active ingredient in 

the same strength and dosage form as 

the ‘‘listed drug,’’ which is a version of 

the drug that was previously approved. 

ANDA applicants do not have to repeat 

the extensive clinical testing otherwise 

necessary to gain approval of a new 

drug application (NDA). The only 

clinical data required in an ANDA are 

data to show that the drug that is the 

subject of the ANDA is bioequivalent to 

the listed drug. 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

agency withdraws or suspends approval 

of the drug’s NDA or ANDA for reasons 

of safety or effectiveness or if FDA 

determines that the listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

Under § 314.161(a)(1) (21 CFR 

314.161(a)(1)), the agency must 

determine whether a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness before an ANDA 

that refers to that listed drug may be 

approved. FDA may not approve an 

ANDA that does not refer to a listed 

drug. Under § 314.161(a)(2), FDA must 

determine whether a listed drug was 

withdrawn from sale for reasons of 

safety or effectiveness whenever a listed 

drug is voluntarily withdrawn from sale 

and ANDAs that refer to the listed drug 

have been approved. Section 314.161(d) 

provides that if FDA determines that a 

listed drug was withdrawn from sale for 

reasons of safety or effectiveness, the 

agency will initiate proceedings that 

could result in the withdrawal of 

approval of the ANDAs that refer to the 

listed drug. 

BUSPAR (buspirone hydrochloride) 

Tablets, 10 mg, 15 mg, and 30 mg, are 

the subject of NDA 18–731, held by 

Bristol-Myers Squibb, and initially 

approved on September 29, 1986 (10 mg 

strength), and April 22, 1996 (15 mg and 

30 mg strengths). BUSPAR is indicated 

for the management of anxiety disorders 

or the short-term relief of the symptoms 

of anxiety. BUSPAR (buspirone 

hydrochloride) Tablets, 10 mg, 15 mg, 

and 30 mg, are currently listed in the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. There are 

approved ANDAs for buspirone 

hydrochloride tablets, 10 mg, 15 mg, 

and 30 mg; these ANDAs are listed in 

the Orange Book and, following the 

discontinuation of BUSPAR, one of 

them was designated as the reference 

listed drug to which new ANDAs 

should refer. 

Lachman Consultant Services, Inc., 

submitted a citizen petition dated May 

4, 2010 (Docket No. FDA–2010–P– 

0234), under 21 CFR 10.30, requesting 

that the agency determine whether 

BUSPAR (buspirone hydrochloride) 

Tablets, 15 mg and 30 mg, were 

withdrawn from sale for reasons of 

safety or effectiveness. Although the 

citizen petition did not address the 10 

mg strength, that strength has also been 

discontinued. On our own initiative, we 

have also determined whether that 

strength was withdrawn for safety or 

effectiveness reasons. 

After considering the citizen petition 

and reviewing agency records, FDA has 

determined under § 314.161 that 

BUSPAR (buspirone hydrochloride) 

Tablets, 10 mg, 15 mg, and 30 mg, were 

not withdrawn for reasons of safety or 

effectiveness. The petitioner has 

identified no data or other information 

suggesting that BUSPAR (buspirone 

hydrochloride) Tablets, 10 mg, 15 mg, 

and 30 mg, were withdrawn for reasons 

of safety or effectiveness. We have 

carefully reviewed our files for records 

concerning the withdrawal of BUSPAR 

(buspirone hydrochloride) Tablets, 10 

mg, 15 mg, and 30 mg, from sale. We 

have also independently evaluated 

relevant literature and data for possible 

postmarketing adverse events and have 

found no information that would 

indicate that this product was 

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Federal Register / Vol. 75, No. 201 / Tuesday, October 19, 2010 / Notices 64311 

withdrawn from sale for reasons of 

safety or effectiveness. 

Accordingly, the agency will continue 

to list BUSPAR (buspirone 

hydrochloride) Tablets, 10 mg, 15 mg, 

and 30 mg, in the ‘‘Discontinued Drug 

Product List’’ section of the Orange 

Book. The ‘‘Discontinued Drug Product 

List’’ delineates, among other items, 

drug products that have been 

discontinued from marketing for reasons 

other than safety or effectiveness. FDA 

will not begin procedures to withdraw 

approval of approved ANDAs that refer 

to BUSPAR. Additional ANDAs for 

buspirone hydrochloride tablets, 10 mg, 

15 mg, and 30 mg, may also be approved 

by the agency as long as they meet all 

other legal and regulatory requirements 

for the approval of ANDAs. If FDA 

determines that labeling for this drug 

product should be revised to meet 

current standards, the agency will 

advise ANDA applicants to submit such 

labeling. 

Dated: October 13, 2010. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2010–26214 Filed 10–18–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Eye Institute; 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 Eye Institute 

Special Emphasis Panel, NIH Training 

Grants. 

Date: December 6, 2010. 

Time: 8:30 a.m. to 5:30 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: Embassy Suites at the Chevy Chase 

Pavilion, 4300 Military Road, NW., 

Washington, DC 20015. 

Contact Person: Daniel R. Kenshalo, PhD, 

Scientific Review Officer, Division of 

Extramural Research, National Eye Institute, 

National Institutes of Health, 5635 Fishers 

Lane, Suite 1300, MSC 9300. 301–451–2020. 

kenshalod@nei.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.867, Vision Research, 

National Institutes of Health, HHS) 

Dated: October 13, 2010. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–26310 Filed 10–18–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Administration for Children and 

Families 

Notice of Meeting; National 

Commission on Children and Disasters 

AGENCY: Administration for Children 

and Families, Department of Health and 

Human Services. 

ACTION: Notice of Meeting. 

DATES: The meeting will be held on 

Monday, November 15, 2010, from 9:30 

a.m. to 3:30 p.m. 

ADDRESSES: The meeting will be held at 

the Administration for Children and 

Families, 901 D Street, SW., 

Washington, DC 20024. To attend either 

in person or via teleconference, please 

register by 5 p.m., Eastern Time, 

November 10, 2010. To register, please 

e-mail Jacqueline.Officer@acf.hhs.gov 

with ‘‘Meeting Registration’’ in the 

subject line, or call (202) 205–9560. 

Registration must include your name, 

affiliation, and phone number. If you 

require a sign language interpreter or 

other special assistance, please call 

Jacqueline Officer at (202) 205–9560 or 

e-mail Jacqueline.Officer@acf.hhs.gov as 

soon as possible and no later than 5 

p.m. Eastern Time, November 1, 2010. 

Agenda: The Commission will: (1) 

Discuss a recommendation to establish 

a National Resource Center on Children 

and Disasters; (2) Discuss 

implementation strategies for 

recommendations published in the 2010 

Report to the President and Congress; 

and (3) Discuss potential issues for 

future study and changes to 

subcommittee structure. 

Written comments may be submitted 

electronically to 

Juliana.Sadovich@acf.hhs.gov with 

‘‘Public Comment’’ in the subject line. 

The Commission recommends that you 

include your name, mailing address and 

an e-mail address or other contact 

information in the body of your 

comment. This ensures that you can be 

identified as the submitter of the 

comment, and it allows the Commission 

to contact you if further information on 

the substance of the comment is needed 

or if your comment cannot be read due 

to technical difficulties. The 

Commission’s policy is that the 

Commission will not edit your 

comment, and any identifying or contact 

information provided in the body of a 

comment will be included as part of the 

comment placed in the official record. 

The Commission will provide an 

opportunity for public comments during 

the public meeting on November 15, 

2010. Those wishing to speak will be 

limited to three minutes each; speakers 

are encouraged to submit their remarks 

in writing in advance to ensure their 

comment is received in case there is 

inadequate time for all comments to be 

heard on November 15, 2010. 

Additional Information: Contact 

CAPT Juliana Sadovich, RN, PhD 

Director, Office of Human Services 

Emergency Preparedness and Response, 

e-mail Juliana.Sadovich@acf.hhs.gov or 

call (202) 401–9306. 

SUPPLEMENTARY INFORMATION: The 

National Commission on Children and 

Disasters is an independent Commission 

directed to conduct a comprehensive 

study to examine and assess the needs 

of children as they relate to preparation 

for, response to, and recovery from all 

hazards, building upon the evaluations 

of other entities and avoiding 

unnecessary duplication by reviewing 

the findings, conclusions, and 

recommendations of these entities. The 

Commission submitted reports to the 

President and the Congress on the 

Commission’s independent and specific 

findings, conclusions, and 

recommendations to address the needs 

of children as they relate to preparation 

for, response to, and recovery from all 

hazards, including major disasters and 

emergencies. 

Dated: October 13, 2010. 

David A. Hansell, 

Acting Assistant Secretary for Children and 

Families. 

[FR Doc. 2010–26231 Filed 10–18–10; 8:45 am] 

BILLING CODE 4184–06–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Toxicology Program (NTP); 

Office of Liaison, Policy and Review 

Meeting of the NTP Board of Scientific 

Counselors 

AGENCY: National Institute of 

Environmental Health Sciences 

(NIEHS), National Institutes of Health. 

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