Federal Register / Vol. 70, No. 20 / Tuesday, February 1, 2005 / Notices 5189

validity of the methodology and 

assumptions used; (3) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (4) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques, 

when appropriate, and other forms of 

information technology.

Infant Formula Recall Regulations—21 

CFR 107.230, 107.240, 107.250, 107.260, 

107.280 (OMB Control Number 0910–

0188)—Extension

Section 412(e) of the Federal Food, 

Drug, and Cosmetic Act (the act) (21 

U.S.C. 350a(e)) provides that if the 

manufacturer of an infant formula has 

knowledge that reasonably supports the 

conclusion that an infant formula 

processed by that manufacturer has left 

its control and may not provide the 

nutrients required in section 412(i) of 

the act or is otherwise adulterated or 

misbranded, the manufacturer must 

promptly notify the Secretary of Health 

and Human Services (the Secretary). If 

the Secretary determines that the infant 

formula presents a risk to human health, 

the manufacturer must immediately take 

all actions necessary to recall shipments 

of such infant formula from all 

wholesale and retail establishments, 

consistent with recall regulations and 

guidelines issued by the Secretary. 

Section 412(f)(2) of the act states that 

the Secretary shall by regulation 

prescribe the scope and extent of recalls 

of infant formula necessary and 

appropriate for the degree of risk to 

human health presented by the formula 

subject to recall. FDA’s infant formula 

recall regulations (part 107 (21 CFR part 

107), subpart E) implement these 

statutory provisions.

Section 107.230 requires each 

recalling firm to conduct an infant 

formula recall with the following 

elements: (1) Evaluate the hazard to 

human health, (2) devise a written recall 

strategy, (3) promptly notify each 

affected direct account (customer) about 

the recall, and (4) furnish the 

appropriate FDA district office with 

copies of these documents. If the 

recalled formula presents a risk to 

human health, the recalling firm must 

also request that each establishment that 

sells the recalled formula post (at point 

of purchase) a notice of the recall and 

provide FDA with a copy of the notice. 

Section 107.240 requires the recalling 

firm to conduct an infant formula recall 

with the following elements: (1) Notify 

the appropriate FDA district office of 

the recall by telephone within 24 hours, 

(2) submit a written report to that office 

within 14 days, and (3) submit a written 

status report at least every 14 days until 

the recall is terminated. Before 

terminating a recall, the recalling firm is 

required to submit a recommendation 

for termination of the recall to the 

appropriate FDA district office and wait 

for written FDA concurrence 

(§ 107.250). Where the recall strategy or 

implementation is determined to be 

deficient, FDA may require the firm to 

change the extent of the recall, carry out 

additional effectiveness checks, and 

issue additional notifications 

(§ 107.260). In addition, to facilitate 

location of the product being recalled, 

the recalling firm is required to 

maintain distribution records for at least 

1 year after the expiration of the shelf 

life of the infant formula (§ 107.280).

The reporting and recordkeeping 

requirements described previously are 

designed to enable FDA to monitor the 

effectiveness of infant formula recalls in 

order to protect babies from infant 

formula that may be unsafe because of 

contamination or nutritional inadequacy 

or otherwise adulterated or misbranded. 

FDA uses the information collected 

under these regulations to help ensure 

that such products are quickly and 

efficiently removed from the market.

FDA estimates the burden of this 

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of Respondents Annual Frequency 

per Response Total Annual Responses Hours per Response Total Hours 

107.230 2 1 2 4,500 9,000

107.240 2 1 2 1,482 2,964

107.250 2 1 2 120 240

107.260 1 1 1 650 650

Total 12,854

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

Under 5 CFR 1320.3(b)(2), the time, 

effort, and financial resources necessary 

to comply with a collection of 

information are excluded from the 

burden estimate if the reporting, 

recordkeeping, or disclosure activities 

needed to comply are usual and 

customary because they would occur in 

the normal course of activities. No 

burden has been estimated for the 

recordkeeping requirement in § 107.280 

because these records are maintained as 

a usual and customary part of normal 

business activities. Manufacturers keep 

infant formula distribution records for 

the prescribed period as a matter of 

routine business practice.

The reporting burden estimate is 

based on agency records, which show 

that there are five manufacturers of 

infant formula and that there have been, 

on average, two infant formula recalls 

per year for the past 3 years.

Dated: January 25, 2005.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 05–1815 Filed 1–31–05; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Cancer Institute; Notice of 

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 meeting of the 

National Cancer Advisory Board. 

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 

5190 Federal Register / Vol. 70, No. 20 / Tuesday, February 1, 2005 / Notices 

language interpretation or other 

reasonable accommodations, should 

notify the Contact Person listed below 

in advance of the meeting. 

A portion of the meeting will be 

closed to the public in accordance with 

the provisions set forth in sections 

552b(c)(4), and 552b(c)(6), 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 Cancer 

Advisory Board Subcommittee on Planning 

and Budget. 

Open: February 15, 2005, 7 p.m. to 9 p.m. 

Agenda: To discuss activities related to the 

Subcommittee on Planning and Budget. 

Place: Hyatt Regency Bethesda, One 

Bethesda Metro Center, Bethesda, MD 20814. 

Contact Person: Ms. Cherie Nichols, 

Executive Secretary, National Cancer 

Institutes, National Institutes of Health, 6116 

Executive Boulevard, 2nd Floor, Room 205, 

Bethesda, MD 20892–2590, (301) 496–6515.

Name of Committee: National Cancer 

Advisory Board. 

Open: February 16, 2005, 8:30 a.m. to 6 

p.m. 

Agenda: Program reports and 

presentations; Business of the Board. 

Place: National Cancer Institute, 9000 

Rockville Pike, Building 31, C Wing, 6th 

Floor, Conference Room 10, Bethesda, MD 

20892. 

Contact Person: Dr. Paulette S. Gray, 

Executive Secretary, National Cancer 

Institute, National Institute of Health, 6116 

Executive Boulevard, 8th Floor, Room 8001, 

Bethesda, MD 20892–8327, (301) 496–5147.

Name of Committee: National Cancer 

Advisory Board. 

Open: February 17, 2005, 8:30 a.m. to 10:30 

a.m. 

Agenda: Program reports and 

presentations; Business of the Board. 

Contact Person: Dr. Paulette S. Gray, 

Executive Secretary, National Cancer 

Institute, National Institutes of Health, 6116 

Executive Boulevard, 8th Floor, Room 8001, 

Bethesda, MD 20892–8327, (301) 496–5147.

Name of Committee: National Cancer 

Advisory Board. 

Closed: February 17, 2005, 10:30 a.m. to 12 

p.m. 

Agenda: Review of grant applications. 

Contact Person: Dr. Paulette S. Gray, 

Executive Secretary, National Cancer 

Institute, National Institutes of Health, 6116 

Executive Boulevard, 8th Floor, Room 8001, 

Bethesda, MD 20892–8327, (301) 496–5147. 

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. 

Information is also available on the 

Institute’s/Center’s home page: http://

deainfo.nci.gov/advisory/ncab.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: January 25, 2005. 

LaVerne Y. Stringfield, 

Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 05–1837 Filed 1–31–05; 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 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 Cancer 

Institute Initial Review Group, Subcommittee 

G—Education. 

Date: March 15–16, 2005. 

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

Agenda: To review and evaluate grant 

applications. 

Place: Holiday Inn Select, 480 King Street, 

Alexandria, VA 22314. 

Contact Person: Ilda M. McKenna, 

Scientific Review Administrator, Research 

Training Review Branch, Division of 

Extramural Activities, National Cancer 

Institute, 6116 Executive Boulevard, Room 

8111, Bethesda, MD 20892, 301–496–7481, 

mckennai@mail.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.

(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: January 25, 2005. 

LaVerne Y. Stringfield, 

Director, Office of Federal Advisory 

Committee Policy.

[FR Doc. 05–1838 Filed 1–31–05; 8:45 am] 

BILLING CODE 4140–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Center on Minority Health and 

Health Disparities 

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 

of the National Advisory Council on 

Minority Health and Health Disparities. 

The meeting will be open to the 

public as indicated below, with 

accordance 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 

Council on Minority Health and Health 

Disparities. 

Date: February 23, 2005. 

Open: 8:30 a.m. to 4 p.m. 

Agenda: The Agenda will include Opening 

Remarks, Administrative Matters, Director’s 

Report, NCMHD, Advisory Council 

Subcommittee Reports, NIH IC Health 

Disparities Update, Program Highlights: 

Select NCMHD Grantees, and other business 

of the Council. 

Place: Double Tree Rockville, 1750 

Rockville Pike, Rockville, MD 20852. 

Closed: 4 p.m to 6 p.m. 

Agenda: To review and evaluate grant 

applications.