Federal Register / Vol. 71, No. 235 / Thursday, December 7, 2006 / Notices 70973 

that is provided to the government of 

Chile and posted on FDA’s Internet site, 

which identifies U.S. dairy product 

manufacturers/processors that have 

expressed interest to FDA in exporting 

dairy products to Chile, are subject to 

FDA jurisdiction, and are not the subject 

of a pending judicial enforcement action 

(i.e., an injunction or seizure) or a 

pending warning letter. The term ‘‘dairy 

products,’’ for purposes of this list, is 

not intended to cover the raw 

agricultural commodity raw milk. 

Application for inclusion on the list is 

voluntary. However, Chile has advised 

that dairy products from firms not on 

this list could be delayed or prevented 

by Chilean authorities from entering 

commerce in Chile. The revised 

guidance explains what information 

firms should submit to FDA in order to 

be considered for inclusion on the list 

and what criteria FDA intends to use to 

determine eligibility for placement on 

the list. The document also explains 

how FDA intends to update the list and 

how FDA intends to communicate any 

new information to Chile. Finally, the 

revised guidance notes that FDA 

considers the information on this list, 

which is provided voluntarily with the 

understanding that it will be posted on 

FDA’s Internet site and communicated 

to, and possibly further disseminated 

by, Chile, to be information that is not 

protected from disclosure under 5 

U.S.C. 552(b)(4). Under this guidance, 

FDA recommends that U.S. firms that 

want to be placed on the list send the 

following information to FDA: Name 

and address of the firm and the 

manufacturing plant; name, telephone 

number, and e-mail address (if 

available) of the contact person; a list of 

products presently shipped and 

expected to be shipped in the next 3 

years; identities of agencies that inspect 

the plant and the date of last inspection; 

plant number and copy of last 

inspection notice; and, if other than an 

FDA inspection, copy of last inspection 

report. FDA requests that this 

information be updated every 2 years. 

In the Federal Register of July 31, 

2006 (71 FR 43202), FDA published a 

60–day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity No. of Respondents 

Annual Frequency 

per Response 

Total Annual Responses Hours per Response Total Hours 

New Written Requests To Be 

Placed On The List 15 1 15 1.5 22.5 

Biannual Update 55 1 55 1.0 55.0 

Occasional Updates 25 1 25 0.5 12.5 

Total 90 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

The estimate of the number of firms 

that will submit new written requests to 

be placed on the list, biannual updates 

and occasional updates is based on the 

FDA’s experience maintaining the list 

over the past 3 years. The estimate of 

the number of hours that it will take a 

firm to gather the information needed to 

be placed on the list or update its 

information is based on FDA’s 

experience with firms submitting 

similar requests. FDA believes that the 

information to be submitted will be 

readily available to the firms. 

To date, over 110 producers have 

sought to be included on the list. FDA 

estimates that, each year, approximately 

15 new firms will apply to be added to 

the list. FDA estimates that a firm will 

require 1.5 hours to read the guidance, 

gather the information needed, and to 

prepare a communication to FDA that 

contains the information and requests 

that the firm be placed on the list. 

Under the revised guidance, every 2 

years each producer on the list must 

provide updated information in order to 

remain on the list. FDA estimates that 

each year approximately half of the 

firms on the list, 55 firms, will resubmit 

the information to remain on the list. 

FDA estimates that a firm already on the 

list will require 1.0 hours to biannually 

update and resubmit the information to 

FDA, including time reviewing the 

information and corresponding with 

FDA. In addition, FDA expects that, 

each year, approximately 25 firms will 

need to submit an occasional update 

and each firm will require 0.5 hours to 

prepare a communication to FDA 

reporting the change. 

Dated: November 30, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E6–20704 Filed 12–6–06; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0426] 

Withdrawal of Federal Register Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; withdrawal. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

withdrawal of a 60-day notice that 

published in the Federal Register of 

October 31, 2006 (71 FR 63765). The 

document published in error. 

DATES: December 7, 2006. 

FOR FURTHER INFORMATION CONTACT: 

Denver Presley, Jr., Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

1472. 

SUPPLEMENTARY INFORMATION: FDA is 

withdrawing a 60-day notice entitled 

‘‘Medical Device User Fee and 

Modernization Act Small Business 

Qualification Certification (Form FDA 

3602),’’ which published in the Federal 

Register of October 31, 2006 (71 FR 

63765), because it is a duplicate of an 

earlier 60-day notice. The earlier 60-day 

notice published in the Federal Register 

of August 29, 2006 (71 FR 51196). The 

October 31 notice was published in 

error. 

Dated: November 30, 2006. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E6–20705 Filed 12–6–06; 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 


sroberts on PROD1PC70 with NOTICES
70974 Federal Register / Vol. 71, No. 235 / Thursday, December 7, 2006 / Notices 

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 purpose of this 

meeting is to evaluate proposals for 

support through the RAID program by 

making available to the research 

community, on a competitive basis, NCI 

new agent development contract 

resources for the preclinical 

development of drugs and biologics. 

The outcome of the evaluation will be 

a decision whether NCI should support 

the request and make available contract 

resources for support through the RAID 

program to the research community, 

NCI new agent development for the 

preclinical development of drugs and 

biologics. The research proposals and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the 

proposed research projects, the 

disclosure of which would constitute a 

clearly unwarranted invasion of 

personal privacy. 

Name of Committee: National Cancer 

Institute Special Emphasis Panel Rapid 

Access to Intervention Development. 

Date: December 20, 2006. 

Time: 8:30 a.m.–5 p.m. 

Agenda: To evaluate Rapid Access to 

Intervention Development Portfolio. 

Place: National Institutes of Health, 6130 

Executive Boulevard, Rm. 319, Rockville, MD 

20852. 

Contact Person: Phyllis G. Bryant, 

Executive Secretary, Program Analyst, 

Developmental Therapeutics Program, 

National Cancer Institute, NIH, 6130 

Executive Boulevard, Rm. 8022, Bethesda, 

MD 20892, 301 435–9137. 

(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: November 30, 2006. 

Anna Snouffer, 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 06–9577 Filed 12–6–06; 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 Meetings 

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 

meetings. 

The meetings 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, 

Demonstration and Education Research 

Grants. 

Date: December 15, 2006. 

Time: 9 a.m. to 1 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Patricia A. Haggerty, PhD, 

Scientific Review Administrator, National 

Heart, Lung, and Blood Institute/NIH, 

Clinical Studies & Training Studies Rev. 

Grp., Division of Extramural Affairs/Section 

Chief, 6701 Rockledge Drive, Room 7194, 

Bethesda, MD 20892, 301/435–0288, 

haggertp@mail.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

Name of Committee: National Heart, Lung, 

and Blood Institute Special Emphasis Panel, 

Coronary Intervention Trial. 

Date: December 19, 2006. 

Time: 12 p.m. to 3 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 6701 

Rockledge Drive, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: William J. Johnson, PhD, 

Scientific Review Administrator, Review 

Branch, Division of Extramural Research 

Activities, NIH/NHLBI, 6701 Rockledge 

Drive, Bethesda, MD 20892–7924, 301–435–

0317, johnsonw@nhlbi.nih.gov. 

This notice is being published less than 15 

days prior to the meeting due to the timing 

limitations imposed by the review and 

funding cycle. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.233, National Center for 

Sleep Disorders Research; 93.837, Heart and 

Vascular Diseases Research; 93.838, Lung 

Diseases Research; 93.839, Blood Diseases 

and Resources Research, National Institutes 

of Health, HHS) 

Dated: December 1, 2006. 

Anna Snouffer, 

Acting Director, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 06–9573 Filed 12–6–06; 8:45 am] 

BILLING CODE 4140–01–M 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Human Genome Research 

Institute; Notice of Closed Meetings 

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 

meetings. 

The meetings 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: Center for Inherited 

Disease Research Access Committee Group 

A. 

Date: January 5, 2007. 

Time: 8:30 a.m. to 3 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: Jerry Roberts, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, National Institutes of Health, 

Building 38A, Bethesda, MD 20892, 301 402–

0838. 

Name of Committee: Center for Inherited 

Disease Research Access Committee Group B. 

Date: January 5, 2007. 

Time: 3:15 p.m. to 4:30 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: Rudy Pozzatti, PhD, 

Scientific Review Administrator, Scientific 

Review Branch, National Human Genome 

Research Institute, 5635 Fishers Lane, Suite 

4076, MSC 9306, Bethesda, MD 20852, (301) 

402–0838, pozzattr@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.172, Human Genome 

Research, National Institutes of Health, HHS) 


sroberts on PROD1PC70 with NOTICES