Federal Register / Vol. 75, No. 224 / Monday, November 22, 2010 / Notices 71135 

Contact Person: Suzan Nadi, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5217B, 

MSC 7846, Bethesda, MD 20892, 301–435– 

1259, nadis@csr.nih.gov. 

Name of Committee: Bioengineering 

Sciences & Technologies Integrated Review 

Group; Biomaterials and Biointerfaces Study 

Section. 

Date: January 5–6, 2011. 

Time: 8 a.m. to 5 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: Steven J Zullo, PhD, 

Scientific Review Officer, Center for 

Scientific Review, National Institutes of 

Health, 6701 Rockledge Drive, Room 5146, 

MSC 7849, Bethesda, MD 20892, 301–435– 

2810, zullost@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: November 16, 2010. 

Jennifer S. Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2010–29361 Filed 11–19–10; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0586] 

Hoffmann-La Roche Inc.; Withdrawal of 

Approval of a New Drug Application 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of a new drug application 

(NDA) for ACCUTANE (isotretinoin) 

Capsules held by Hoffmann-La Roche 

Inc., 340 Kingsland St., Nutley, NJ 

07110–1199. Hoffmann-La Roche Inc. 

notified the Agency in writing that the 

drug product was no longer marketed 

and requested that the approval of the 

application be withdrawn. 

DATES: Effective Date: November 22, 

2010. 

FOR FURTHER INFORMATION CONTACT: 

Florine P. Purdie, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6366, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: HoffmannLa Roche Inc. has requested that FDA 

withdraw approval of NDA 18–662, 

ACCUTANE (isotretinoin) Capsules, 

under the process in § 314.150(c) (21 

CFR 314.150(c)), stating that the drug 

product is no longer marketed. 

Hoffmann-La Roche Inc. has also, by its 

request, waived its opportunity for a 

hearing. Withdrawal of approval of an 

application under § 314.150(c) is 

without prejudice to refiling. 

Therefore, under section 505(e) of the 

Federal Food, Drug, and Cosmetic Act 

(the FD&C Act) (21 U.S.C. 355(e)) and 

under authority delegated to the 

Director, Center for Drug Evaluation and 

Research, by the Commissioner of Food 

and Drugs, approval of NDA 18–662, 

ACCUTANE (isotretinoin) Capsules, and 

all amendments and supplements 

thereto, is hereby withdrawn, effective 

November 22, 2010. Introduction or 

delivery for introduction into interstate 

commerce of a product without an 

approved application violates sections 

301(a) and (d) of the FD&C Act (21 

U.S.C. 331(a) and (d)). ACCUTANE 

(isotretinoin) Capsules that are in 

inventory on the date that this notice 

becomes effective (see the DATES

section) may continue to be dispensed 

until the inventories have been depleted 

or the drug product has reached its 

expiration date or otherwise become 

violative, whichever occurs first. 

In the Federal Register of July 7, 2010 

(75 FR 39024), FDA issued a notice 

announcing its determination that 

ACCUTANE (isotretinoin) Capsules 

were not withdrawn from sale for 

reasons of safety or effectiveness, and 

isotretinoin continues to be marketed 

under approved abbreviated new drug 

applications (ANDAs). The holders of 

ANDAs for isotretinoin are subject to an 

approved risk evaluation and mitigation 

strategy (REMS) under section 505–1 of 

the FD&C Act (21 U.S.C. 355–1), and the 

REMS, known as the iPLEDGE program, 

remains in effect. 

Dated: November 2, 2010. 

Janet Woodcock, 

Director, Center for Drug Evaluation and 

Research. 

[FR Doc. 2010–29348 Filed 11–19–10; 8:45 am] 

BILLING CODE 4160–01–P 

ADVISORY COUNCIL ON HISTORIC 

PRESERVATION 

Notice of Meeting; Advisory Council on 

Historic Preservation 

AGENCY: Advisory Council on Historic 

Preservation. 

ACTION: Notice of meeting. 

SUMMARY: Notice is hereby given that 

the Advisory Council on Historic 

Preservation (ACHP) will meet 

Thursday, December 2, 2010. The 

meeting will be held in Room MO9 of 

the Old Post Office Building, 1100 

Pennsylvania Ave, NW., Washington, 

DC at 9 a.m. 

The ACHP was established by the 

National Historic Preservation Act of 

1966 (16 U.S.C. 470 et seq.) to advise the 

President and Congress on national 

historic preservation policy and to 

comment upon Federal, federally 

assisted, and federally licensed 

undertakings having an effect upon 

properties listed in or eligible for 

inclusion in the National Register of 

Historic Places. The ACHP’s members 

are the Architect of the Capitol; the 

Secretaries of the Interior, Agriculture, 

Defense, Housing and Urban 

Development, Commerce, Education, 

Veterans Affairs, and Transportation; 

the Administrator of the General 

Services Administration; the Chairman 

of the National Trust for Historic 

Preservation; the President of the 

National Conference of State Historic 

Preservation Officers; a Governor; a 

Mayor; a Native American; and eight 

non-Federal members appointed by the 

President. 

Call to Order—9 a.m. 

I. Chairman’s Welcome 

II. Chairman’s Report 

III. Executive Director’s Report 

IV. Native American Activities 

A. Native American Program Report 

1. HUD Delegation of Tribal 

Consultation Responsibilities 

2. DOI–DoD–ACHP Memorandum of 

Understanding on Consultation 

with Native Hawaiians 

B. Native American Advisory Group 

V. Strategic Planning: Next Steps 

VI. Sustainability and Historic 

Preservation Task Force 

VII. Preservation Initiatives Committee 

A. America’s Great Outdoors Initiative 

and Historic Preservation 

B. Economic Benefits Study 

C. Legislation 

VIII. Federal Agency Programs 

Committee 

A. Historic Preservation and Energy 

Development Working Group 

B. National Trust Section 106 Report 

C. Section 106 Update 

IX. Communications, Education, and 

Outreach Committee 

A. Engaging Youth in Historic 

Preservation 

B. New Directions for ACHP Awards 

Programs 

X. New Business 

XI. Adjourn 

Note: The meetings of the ACHP are open 

to the public. 


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