5188 Federal Register / Vol. 70, No. 20 / Tuesday, February 1, 2005 / Notices 

of each such program and each 

pregnancy success rate which the 

program failed to report. 

This Announcement includes 

information on the change in the data 

collection contractor and the change in 

the approved data reporting system for 

the 2004, 2005, 2006, 2007, and 2008 

ART data reporting years in accordance 

with the FCSRCA. This Announcement 

supplements the September 1, 2000 and 

the February 5, 2004, notices.

SUPPLEMENTARY INFORMATION: CDC has 

contracted with Westat to develop a 

data reporting system and to collect 

annual clinic-specific and cycle-specific 

data from all practicing assisted 

reproductive technology clinics in the 

U.S. and its territories for the 2004, 

2005, 2006, 2007, and 2008 ART data 

reporting years. The contract covers 

clinic tracking, data collection and 

quality assurance, and validation 

activities. As such, Westat is the new 

contractor for ART data collection for 

the 2004 through 2008 ART data 

reporting years. 

The new Web-based data reporting 

system (developed by Westat) for the 

2004, 2005, 2006, 2007, and 2008 ART 

data reporting years will be called the 

National ART Surveillance System 

(NASS). As such, NASS will be the only 

approved data reporting system for 2004 

through 2008 ART data submissions. 

ART programs should be aware that 

Westat will develop and provide all 

necessary instruction materials for 

extracting and importing data from 

other electronic medical record systems 

into NASS and for checking imported 

data to ensure that it retains the 

accuracy and compatibility of the data 

entry system from which it was 

extracted. 

The anticipated deadline for reporting 

is December 15 of the year 1 year 

subsequent to the reporting year in 

question. (For example, the anticipated 

deadline to report data on cycles 

initiated in 2004 is December 15, 2005.) 

An ART program will not be considered 

to be in compliance with the federal 

reporting requirements of FCSRCA if the 

ART program was in operation in the 

full year that is being reported, i.e., the 

clinic was in operation after January 1 

of the reporting year, and fails to submit 

a dataset to Westat in the required data 

reporting system (NASS) by the 

reporting deadline. ART programs 

considered to not be compliant with the 

federal reporting requirements of 

FCSRCA will be listed as non-reporters 

in the published report. 

The data reporting activities and the 

amount and type of data collected will 

be similar to the current system 

requirements outlined in the September 

1, 2000 Federal Register notice (Volume 

65, No. 171, pages 53310–53316). CDC 

has completely funded the data 

reporting activities for the 2004 through 

2008 reporting years. Thus, ART 

programs will not be charged fees to 

obtain the new reporting system or to 

submit data using the new reporting 

system. 

Validation activities for the 2004 

through 2008 data reporting years will 

be similar to those described in the 

September 1, 2000 Federal Register

notice (Volume 65, No. 171, pages 

53310–53316). Westat will provide the 

necessary personnel to perform the 

validation site visits. 

Each ART program should be aware 

that the Paperwork Reduction Act is 

applicable to this data collection. Under 

the Paperwork Reduction Act of 1995, a 

Federal agency shall not conduct or 

sponsor a collection of information from 

ten or more persons other than Federal 

employees, unless the agency has 

submitted a Standard Form 83, 

Clearance Request, to the Director of the 

Office of Management and Budget 

(OMB), and OMB has approved the 

collection of information. A person is 

not required to respond to a collection 

of information unless it displays a 

currently valid OMB control number. 

CDC has obtained OMB approval to 

collect this data under OMB control No. 

0920–0556. 

CDC will continue to provide 

information to all ART programs 

regarding data collection activities as 

information becomes available.

FOR FURTHER INFORMATION CONTACT:

Victoria Wright, Assisted Reproductive 

Technology Epidemiology Unit at (770) 

488–6384.

Dated: January 25, 2005. 

James D. Seligman, 

Associate Director for Program Services, 

Centers for Disease Control and Prevention.

[FR Doc. 05–1787 Filed 1–31–05; 8:45 am] 

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005N–0029]

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Infant Formula 

Recall Regulations

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal agencies are required to 

publish notice in the Federal Register

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

requirements related to the recall of 

infant formula.

DATES: Submit written or electronic 

comments on the collection of 

information by April 4, 2005.

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http://

www.fda.gov/dockets/ecomments. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document.

FOR FURTHER INFORMATION CONTACT:

Peggy Robbins, Office of Management 

Programs (HFA–250), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–827–1223.

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document.

With respect to the following 

collection of information, FDA invites 

comments on these topics: (1) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FDA’s functions, including whether 

the information will have practical 

utility; (2) the accuracy of FDA’s 

estimate of the burden of the proposed 

collection of information, including the 

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