55784 Federal Register / Vol. 72, No. 189 / Monday, October 1, 2007 / Notices 

7For example, if a person is marketing an 

unapproved product containing both hydrocodone 

bitartrate and timed-release guaifenesin on or after 

August 27, 2007, then under the notice FDA issued 

May 29, 2007 (72 FR 29517), that person is subject 

to immediate enforcement; FDA will not extend the 

exercise of its enforcement discretion to the later 

dates set out in this notice. 

unapproved hydrocodone products 

based on FDA’s exercise of enforcement 

discretion as set forth in this notice. 

FDA also will not exercise its 

enforcement discretion with respect to 

continued manufacturing or shipping of 

any combination drug product that 

contains a drug subject to an earlier 

deadline for the exercise of agency 

enforcement discretion.7

Drug manufacturers and distributors 

should be aware that the agency is 

exercising its enforcement discretion as 

described previously only in regard to 

unapproved drug products containing 

hydrocodone that are marketed under 

an NDC number listed with the agency 

on the effective date of this notice. 

Unapproved drug products containing 

hydrocodone that are not currently 

marketed, or that are currently marketed 

but are not listed with the agency on the 

effective date of this notice, must, as of 

the effective date of this notice, have 

approved applications prior to their 

introduction or delivery for introduction 

into interstate commerce. Moreover, 

submission of an application does not 

excuse timely compliance with this 

notice. 

C. Discontinued Products 

Some firms may have previously 

discontinued the manufacturing or 

distribution of products covered by this 

notice without removing them from the 

listing of their products under section 

510(j) of the act. Other firms may 

discontinue manufacturing or marketing 

listed products in response to this 

notice. Firms that wish to notify the 

agency of product discontinuation 

should send a letter, signed by the firm’s 

chief executive officer, fully identifying 

the discontinued product(s), including 

the product NDC number(s), and stating 

that the product(s) has (have) been 

discontinued. The letter should be sent 

to Jennifer Devine (see ADDRESSES) with 

a copy to the district director of the 

firm’s FDA district office. Firms should 

also update the listing of their 

product(s) under section 510(j) of the act 

to reflect discontinuation of unapproved 

hydrocodone products. FDA plans to 

rely on its existing records, the results 

of a subsequent inspection, or other 

available information when we evaluate 

whether to initiate enforcement action. 

D. Reformulated Products 

In addition, FDA cautions firms 

against reformulating their products into 

unapproved new drugs without 

hydrocodone that are marketed under 

the same name or substantially the same 

name (including a new name that 

contains the old name) in anticipation 

of an enforcement action based on this 

notice. In the Marketed Unapproved 

Drugs CPG, FDA stated that it intends to 

give higher priority to enforcement 

actions involving unapproved drugs that 

are reformulated to evade an anticipated 

FDA enforcement action. In addition, 

reformulated products marketed under a 

name previously identified with a 

different active ingredient, or 

combination of active ingredients, have 

the potential to confuse healthcare 

practitioners and harm patients. 

This notice is issued under sections 

502 and 505 of the act (21 U.S.C. 352) 

and under authority delegated to the 

Deputy Commissioner for Policy under 

section 1410.10 of the FDA Staff Manual 

Guide. 

Dated: September 25, 2007. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E7–19340 Filed 9–28–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007P–0074] 

Joint Meeting of the Nonprescription 

Drugs Advisory Committee and the 

Pediatric Advisory Committee; 

Amendment of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

amendment to the notice of a joint 

meeting of the Nonprescription Drugs 

Advisory Committee and the Pediatric 

Advisory Committee. This meeting was 

announced in the Federal Register of 

August 16, 2007 (72 FR 46091). The 

amendment is being made to reflect a 

change in the Procedure portion of the 

document. There are no other changes. 

FOR FURTHER INFORMATION CONTACT: 

Darrell Lyons, Center for Drug 

Evaluation and Research (HFD–21), 

Food and Drug Administration, 5630 

Fishers Lane (for express delivery, 5630 

Fishers Lane, rm. 1093), Rockville, MD 

20857, 301–827–7001, FAX: 301–827–

6776, e-mail: darrell.lyons@fda.hhs.gov, 

or FDA Advisory Committee 

Information Line, 1–800–741–8138 

(301–443–0572 in the Washington, DC 

area), codes 3014512541 and 

8732310001. Please call the Information 

Line for up-to-date information on this 

meeting. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of August 16, 2007, 

FDA announced that a joint meeting of 

Nonprescription Drugs Advisory 

Committee and the Pediatric Advisory 

Committee would be held on October 18 

and 19, 2007. On page 46091, in the 

third column, the third sentence of the 

Procedure portion of the document is 

changed to read as follows: 

Procedure: Oral presentations from 

the public will be scheduled between 

approximately 8:30 a.m. and 10:30 a.m. 

on October 19, 2007. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app. 2) and 21 CFR part 14, 

relating to advisory committees. 

Dated: September 23, 2007. 

Randall W. Lutter, 

Deputy Commissioner for Policy. 

[FR Doc. E7–19332 Filed 9–28–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer 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 a meeting of the 

Board of Scientific Counselors for 

Clinical Sciences and Epidemiology 

National Cancer Institute. 

The meetings will be closed to the 

public as indicated below in accordance 

with the provisions set forth in section 

552b(c)(6), Title 5 U.S.C., as amended 

for the review, discussion, and 

evaluation of individual intramural 

programs and projects conducted by the 

National Cancer Institute, including 

consideration of personnel 

qualifications and performance, and the 

competence of individual investigators, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Board of Scientific 

Counselors for Clinical Sciences and 

Epidemiology National Cancer Institute. 

Date: November 5, 2007. 

Time: 9 a.m. to 2 p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

mstockstill on PROD1PC66 with NOTICES

Federal Register / Vol. 72, No. 189 / Monday, October 1, 2007 / Notices 55785 

Place: National Institutes of Health, 

National Cancer Institute, 9000 Rockville 

Pike, Building 31/Conference Room 10, 

Rockville, MD 20852. 

Time: 6 p.m. to 10 p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: Double Tree Hotel, 8120 Wisconsin 

Avenue, Bethesda, MD 20814. 

Contact Person: Brian E. Wojcik, PhD, 

Senior Review Administrator, Institute 

Review Office, Office of the Director, 

National Cancer Institute, 6116 Executive 

Boulevard, Room 2114, Bethesda, MD 20892, 

(301) 496–7628, wojcikb@mail.nih.gov. 

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: 

deainfo.nci.nih.gov/advisory/bsc.htm, where 

an agenda and any additional information for 

the meeting will be posted when available. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

Diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

Research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: September 21, 2007. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–4819 Filed 9–28–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer 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 a meeting of the 

Board of Scientific Counselors for Basic 

Sciences National Cancer Institute. The 

meeting will be closed to the public as 

indicated below in accordance with the 

provisions set forth in section 

552b(c)(6), Title 5 U.S.C., as amended 

for the review, discussion, and 

evaluation of individual intrumural 

programs and projects conducted by the 

National Cancer Institute, including 

consideration of personnel 

qualifications and performance, and the 

competence of individual investigators, 

the disclosure of which would 

constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: Board of Scientific 

Counselors for Basic Sciences National 

Cancer Institute. 

Date: November 5–6, 2007. 

Time: November 5, 2007, 6 p.m. to 10 p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: Double Tree Hotel, 8120 Wisconsin 

AVenue, Bethesda, MD 20814. 

Time: November 6, 2007, 9 a.m. to 3:30 

p.m. 

Agenda: To review and evaluate personal 

qualifications and performance, and 

competence of individual investigators. 

Place: National Institutes of Health, 

National Cancer Institute, 9000 Rockville 

Pike, Building 31, Conference Room 6, 

Bethesda, MD 20892. 

Contact Person: Florence E. Farber, PhD, 

Executive Secretary, Office of the Director, 

National Cancer Institute, National Institutes 

of Health, 6116 Executive Boulevard, Room 

2115, Bethesda, MD 20892, 301–496–7628, 

ff6p@nih.gov. 

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. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.392, Cancer Construction; 

93.393, Cancer Cause and Prevention 

Research; 93.394, Cancer Detection and 

diagnosis Research; 93.395, Cancer 

Treatment Research; 93.396, Cancer Biology 

research; 93.397, Cancer Centers Support; 

93.398, Cancer Research Manpower; 93.399, 

Cancer Control, National Institutes of Health, 

HHS) 

Dated: September 21, 2007. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–4820 Filed 9–28–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center for Complementary & 

Alternative Medicine; Amended Notice 

of Meeting 

Notice is hereby given of a change in 

the meeting of the National Center for 

Complementary and Alternative 

Medicine Special Emphasis Panel, 

October 25, 2007, 9 a.m. to October 26, 

2007, 5 p.m. Bethesda Marriott, 5151 

Pooks Hill Road, Bethesda, MD, 20814 

which was published in the Federal 

Register on August 16, 2007, 7246093. 

The meeting notice is being amended 

due to the meeting dates changing from 

October 25–26, 2007 to October 25, 

2007. The meeting is closed to the 

public. 

Dated: September 19, 2007. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–4811 Filed 9–28–07; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Heart, Lung, and Blood 

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 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 Heart, Lung, 

and Blood Institute Special Emphasis Panel; 

Short Term Research Education Program 

(R25’s). 

Date: October 22, 2007. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Marriott Bethesda North Hotel & 

Conference Center, 5701 Marinelli Road, 

Bethesda, MD 20852. 

Contact Person: Rina Das, PhD, Scientific 

Review Administrator, Review Branch/ 

DERA, National Heart, Lung, and Blood 

Institute, 6701 Rockledge Drive, Room 7200, 

Bethesda, MD 20892–7294, (301) 435–0297, 

dasr2@nhlbi.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 98.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: September 19, 2007. 

Jennifer Spaeth, 

Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 07–4810 Filed 09–28–07; 8:45 am] 

BILLING CODE 4140–01–M 

mstockstill on PROD1PC66 with NOTICES