Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Notices 24723 

1 In April 1997, FDA proposed a voluntary 

procedure (proposed § 170.36) whereby 

manufacturers would notify FDA about a view that 

a particular use (or uses) of a substance is not 

subject to the statutory premarket approval 

requirements based on a determination that such 

use is generally recognized as safe (GRAS) (62 FR 

18938, April 17, 1997). FDA invited interested 

persons who determine that a use of a substance is 

GRAS to notify FDA of those determinations, under 

the framework of the 1997 proposed rule, during 

the interim between the proposed and final rules 

(62 FR 18938 at 18954). FDA received OMB 

approval for submissions received under the 

framework of the 1997 proposed rule. 

Center for Food Safety and Applied 

Nutrition (CFSAN), Food and Drug 

Administration, 5100 Paint Branch 

Pkwy, College Park, MD 20740, 240– 

402–1200. Send one self-addressed 

adhesive label to assist that office in 

processing your requests. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the draft guidance 

document. 

Submit electronic comments on the 

draft guidance to http:// 

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Annette M. McCarthy, Center for Food 

and Applied Nutrition (HFS–205), Food 

and Drug Administration, 5100 Paint 

Branch Pkwy., College Park, MD 20740, 

240–402–1057, FAX 301–436–2972, 

email: Annette.McCarthy@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance document entitled 

‘‘Guidance for Industry: Assessing the 

Effects of Significant Manufacturing 

Process Changes, Including Emerging 

Technologies, on the Safety and 

Regulatory Status of Food Ingredients 

and Food Contact Substances, Including 

Food Ingredients That Are Color 

Additives.’’ This draft guidance, when 

finalized, will represent FDA’s current 

thinking on the factors to be considered 

when determining whether changes in 

manufacturing process, including the 

intentional reduction in particle size to 

the nanoscale, for a food substance 

already in the market affects the safety 

and regulatory status of the food 

substance, and whether a new 

regulatory submission is warranted. 

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 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 

requirements of applicable statutes and 

regulations. 

II. Paperwork Reduction Act of 1995 

This draft 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 §§ 170.101, 170.106, 

171.1 (21 CFR 171.1) have been 

approved under OMB control number 

0910–0495; the collections of 

information in §§ 70.25, 71.1, 170.35, 

and 171.1 have been approved under 

OMB control number 0910–0016; the 

collections of information in § 170.39 

have been approved under OMB control 

number 0910–0298; and the collections 

of information in proposed § 170.36 1

have been approved under OMB control 

number 0910–0342. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. 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 document at either 

http://www.regulations.gov or http:// 

www.fda.gov/FoodGuidances. Always 

access an FDA guidance document by 

using FDA’s Web site listed previously 

to find the most current version of the 

guidance. 

Dated: April 17, 2012. 

Leslie Kux, 

Assistant Commissioner for Policy. 

[FR Doc. 2012–9936 Filed 4–24–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0370] 

AstraZeneca Pharmaceuticals LP; 

Withdrawal of Approval of a New Drug 

Application for IRESSA 

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 IRESSA (gefitinib) Tablets 

held by AstraZeneca Pharmaceuticals 

LP (AstraZeneca), 1800 Concord Pike, 

P.O. Box 8355, Wilmington, DE 19803– 

8355. AstraZeneca has voluntarily 

requested that approval of this 

application be withdrawn, thereby 

waiving its opportunity for a hearing. 

DATES: Effective April 25, 2012. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6250, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: FDA 

approved IRESSA (gefitinib) Tablets on 

May 2, 2003, under the Agency’s 

accelerated approval regulations, 21 

CFR part 314, subpart H. IRESSA is 

indicated as monotherapy after failure 

of both platinum-based and docetaxel 

chemotherapies for the continued 

treatment of patients with locally 

advanced or metastatic non-small cell 

lung cancer who are benefiting or have 

benefited from IRESSA. On August 26, 

2010, FDA requested that AstraZeneca 

voluntarily withdraw IRESSA (gefitinib) 

Tablets from the market, because the 

postmarketing studies required as a 

condition of approval under subpart H 

failed to verify and confirm clinical 

benefit. In a letter dated February 1, 

2011, AstraZeneca requested that FDA 

withdraw approval of NDA 21–399 for 

IRESSA (gefitinib) Tablets, which 

AstraZeneca characterized as a business 

decision, effective September 30, 2011. 

In that letter, AstraZeneca waived any 

opportunity for a hearing otherwise 

provided under §§ 314.150 and 314.530. 

The letter also stated that approximately 

250 patients then receiving IRESSA 

treatment through the Iressa Access 

Program would continue treatment 

under an expanded access program, but 

no new patients would be added to the 

protocol. In FDA’s letter of February 4, 

2011, responding to AstraZeneca’s 


pmangrum on DSK3VPTVN1PROD with NOTICES
24724 Federal Register / Vol. 77, No. 80 / Wednesday, April 25, 2012 / Notices 

February 1, 2011, letter, the Agency 

acknowledged AstraZeneca’s agreement 

to permit FDA to withdraw approval of 

IRESSA under § 314.150(d) and waive 

its opportunity for a hearing. 

Therefore, under section 505(e) of the 

Federal Food, Drug, and Cosmetic Act 

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

§ 314.150(d), and under authority 

delegated by the Commissioner to the 

Director, Center for Drug Evaluation and 

Research, approval of NDA 21–399, and 

all amendments and supplements 

thereto, is withdrawn (see DATES). 

Distribution of this product in interstate 

commerce without an approved 

application is illegal and subject to 

regulatory action (see sections 505(a) 

and 301(d) of the FD&C Act (21 U.S.C. 

355(a) and 331(d)). 

Dated: April 5, 2012. 

Janet Woodcock, 

Director, Center for Drug Evaluation and 

Research. 

[FR Doc. 2012–9944 Filed 4–24–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2012–N–0376] 

Sanofi-aventis, U.S., LLC; Withdrawal 

of Approval of a New Drug Application 

for OFORTA 

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 OFORTA (fludarabine 

phosphate) Tablets held by sanofiaventis, U.S., LLC (sanofi-aventis), 55 

Corporate Dr., Bridgewater, NJ 08807– 

0977. Sanofi-aventis has voluntarily 

requested that approval of this 

application be withdrawn, thereby 

waiving its opportunity for a hearing. 

DATES: Effective December 31, 2011. 

FOR FURTHER INFORMATION CONTACT: 

Martha Nguyen, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, rm. 6250, 

Silver Spring, MD 20993–0002, 301– 

796–3601. 

SUPPLEMENTARY INFORMATION: FDA 

approved OFORTA (fludarabine 

phosphate) Tablets on December 18, 

2008, under the Agency’s accelerated 

approval regulations, 21 CFR part 314, 

subpart H. OFORTA is approved for use 

as a single agent for the treatment of 

adult patients with B-cell chronic 

lymphocytic leukemia whose disease 

has not responded to or has progressed 

during or after treatment with at least 

one standard alkylating agentcontaining regimen. On February 10, 

2011, FDA requested that sanofi-aventis 

voluntarily withdraw OFORTA 

(fludarabine phosphate) Tablets from 

the market, because the postmarketing 

study required as a condition of 

approval under subpart H had not been 

completed and clinical benefit had not 

been verified. In a letter dated June 24, 

2011, sanofi-aventis requested that FDA 

withdraw approval of NDA 22–273 for 

OFORTA (fludarabine phosphate) 

Tablets under § 314.150(d), noting the 

lack of commercial demand for 

OFORTA and significant challenges to 

completing the postmarketing study. In 

that letter, sanofi-aventis also waived its 

opportunity for a hearing, otherwise 

provided under §§ 314.150 and 314.530. 

In a letter dated July 8, 2011, the Agency 

acknowledged sanofi-aventis’ agreement 

to permit FDA to withdraw approval of 

OFORTA under § 314.150(d) and waive 

its opportunity for a hearing. The 

Agency noted that the required 

postmarketing study had not been 

completed and clinical benefit had not 

been verified. 

Therefore, under section 505(e) of the 

Federal Food, Drug, and Cosmetic Act 

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

§ 314.150(d), and under authority 

delegated by the Commissioner to the 

Director, Center for Drug Evaluation and 

Research, approval of NDA 22–273, and 

all amendments and supplements 

thereto, is withdrawn (see DATES). 

Distribution of this product in interstate 

commerce without an approved 

application is illegal and subject to 

regulatory action (see sections 505(a) 

and 301(d) of the FD&C Act (21 U.S.C. 

355(a) and 331(d)). 

Dated: April 5, 2012. 

Janet Woodcock, 

Director, Center for Drug Evaluation and 

Research. 

[FR Doc. 2012–9943 Filed 4–24–12; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of General Medical 

Sciences; 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 General Medical 

Sciences Council. 

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, 

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 

General Medical Sciences Council. 

Date: May 24–25, 2012. 

Closed: May 24, 2012, 8:30 a.m. to 5 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

Natcher Building, Conference Rooms E1 & 

E2, 45 Center Drive, Bethesda, MD 20892. 

Open: May 25, 2012, 8:30 a.m. to 

Adjournment. 

Agenda: For the discussion of program 

policies and issues, opening remarks, report 

of the Director, NIGMS, and other business 

of the Council. 

Place: National Institutes of Health, 

Natcher Building, Conference Rooms E1 & 

E2, 45 Center Drive, Bethesda, MD 20892. 

Contact Person: Ann A. Hagan, Ph.D., 

Associate Director for Extramural Activities, 

NIGMS, NIH, DHHS, 45 Center Drive, Room 

2AN24H, MSC 6200, Bethesda, MD 20892, 

(301) 594–4499, hagana@nigms.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 taxis, 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.nigms.nih.gov/About/Council/ where 

an agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.375, Minority Biomedical 

Research Support; 93.821, Cell Biology and 

Biophysics Research; 93.859, Pharmacology, 

Physiology, and Biological Chemistry 


pmangrum on DSK3VPTVN1PROD with NOTICES