Federal Register / Vol. 72, No. 8 / Friday, January 12, 2007 / Notices 1539 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2006N–0528] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Infant Formula 

Requirements 

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 

information collection regarding the 

manufacture of infant formula, 

including infant formula labeling, 

quality control procedures, notification 

requirements, and recordkeeping. 

DATES: Submit written or electronic 

comments on the collection of 

information by March 13, 2007. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to: http://www.fda.gov/ 

dockets/ecomments. Submit written 

comments on the collection of 

information 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: 

Jonna Capezzuto, Office of the Chief 

Information Officer (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659. 

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 

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 Requirements—21 CFR 

Parts 106 and 107 (OMB Control 

Number 0910–0256)—Extension 

Statutory requirements for infant 

formula under the Federal Food, Drug, 

and Cosmetic Act (the act) are intended 

to protect the health of infants and 

include a number of reporting and 

recordkeeping requirements. Among 

other things, section 412 of the act (21 

U.S.C. 350a) requires manufacturers of 

infant formula to establish and adhere to 

quality control procedures, notify FDA 

when a batch of infant formula that has 

left the manufacturers’ control may be 

adulterated or misbranded, and keep 

records of distribution. FDA has issued 

regulations to implement the act’s 

requirements for infant formula in 21 

CFR part 106 and part 107 (21 CFR parts 

106 and 107). FDA also regulates the 

labeling of infant formula under the 

authority of section 403 of the act (21 

U.S.C. 343). Under the labeling 

regulations for infant formula in part 

107, the label of an infant formula must 

include nutrient information and 

directions for use. The purpose of these 

labeling requirements is to ensure that 

consumers have the information they 

need to prepare and use infant formula 

appropriately. In a notice of proposed 

rulemaking published in the Federal 

Register of July 9, 1996 (61 FR 36154) 

(the 1996 proposed rule), FDA proposed 

changes in the infant formula 

regulations, including some of those 

listed in tables 1 and 2 of this 

document. The 1996 proposed rule 

included revised burden estimates for 

the proposed changes and solicited 

public comment. In the interim, 

however, FDA is seeking an extension of 

OMB approval for the current 

regulations so that it can continue to 

collect information while the proposal 

is pending. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Section of the Federal Food, 

Drug, and Cosmetic Act or 21 

CFR Section 

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses2

Hours per 

Response Total Hours 

Section 412(d) of the act 5 13 65 10 650 

21 CFR 106.120(b) 5 0 .25 1 .25 4 5 

21 CFR 107.10(a) and 107.20 5 13 65 8 520 

21 CFR 107.50(b)(3) and (b)(4) 3 2 6 4 24 

21 CFR 107.50(e)(2) 3 0 .33 1 4 4 

Total 1,203 

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

2Manufacturers may submit infant formula notifications in electronic format. 


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1540 Federal Register / Vol. 72, No. 8 / Friday, January 12, 2007 / Notices 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency 

per Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

106.100 5 10 50 4,000 200,000 

107.50(c)(3) 3 10 30 3,000 90,000 

Total 290,000 

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

In compiling these estimates, FDA 

consulted its records of the number of 

infant formula submissions received in 

the past. The figures for hours per 

response are based on estimates from 

experienced persons in the agency and 

in industry. 

Dated: January 8, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–331 Filed 1–11–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Notice Regarding 340B Drug Pricing 

Program-Contract Pharmacy Services 

AGENCY: Health Resources and Services 

Administration, HHS. 

ACTION: Notice. 

SUMMARY: Section 340B of the Public 

Health Service Act implements a drug 

pricing program in which manufacturers 

who sell covered outpatient drugs to 

covered entities must agree to charge a 

price that will not exceed an amount 

determined under a statutory formula. 

The purpose of this notice is to inform 

interested parties of proposed 

guidelines regarding contract pharmacy 

services that will allow covered entities 

to utilize contract pharmacy services 

arrangements previously limited to the 

Alternative Methods Demonstration 

Project program. 

DATES: The public is invited to comment 

on the proposed guidelines by March 

13, 2007. After consideration of the 

submitted comments, the Health 

Resources and Services Administration 

(HRSA) will issue the final guidelines. 

ADDRESSES: Address all comments to 

Mr. Bradford R. Lang, Public Health 

Analyst, Office of Pharmacy Affairs 

(OPA), Health Resources and Services 

Administration (HRSA), 5600 Fishers 

Lane, Parklawn Building, Room 10C–03, 

Rockville, MD 20857. 

FOR FURTHER INFORMATION CONTACT: Mr. 

Jimmy Mitchell, Director, OPA, HRSA, 

5600 Fishers Lane, Parklawn Building, 

Room 10C–03, Rockville, MD 20857, or 

by telephone through the Pharmacy 

Services Support Center at 1–800–628–

6297. 

SUPPLEMENTARY INFORMATION: 

A. Background 

Section 602 of Public Law 102–585, 

the Veterans Health Care Act of 1992, 

enacted section 340B of the Public 

Health Service Act, Limitation on Prices 

of Drugs Purchased by Covered Entities. 

Previous guidelines pertaining to 

contract pharmacy services for the 340B 

drug pricing program (61 FR 43549, 

Aug. 23, 1996) stated that a covered 

entity could contract with only one 

pharmacy to provide all pharmacy 

services for any particular site of the 

covered entity. Furthermore, if the 

contract pharmacy had multiple 

locations, the covered entity site had to 

choose one, and only one, contract 

pharmacy location for provision of these 

services. 

In 2001, HRSA established 

Alternative Methods Demonstration 

Projects (AMDPs) which allowed 

covered entities that applied and were 

approved by HRSA to pursue 

alternatives to contracting with a single 

pharmacy. These alternative models 

included the following: (1) The use of 

multiple contract pharmacy service 

sites, (2) the utilization of a contract 

pharmacy to supplement in-house 

pharmacy services, and/or (3) the 

development of a network of 340B 

covered entities. The intent was to allow 

community health centers and other 

340B safety-net providers to develop 

new ways to improve access to 340B 

prescription drugs for their patients. 

From the time of the program’s 

inception until the end of April 2006, a 

total of 18 AMDPs were approved. Of 

those, 11 utilize a multiple contract 

pharmacies model, four establish a 

network of 340B covered entities, one is 

a combination of the network model and 

the multiple contract pharmacies model, 

one utilizes a contract pharmacy to 

supplement an in-house pharmacy, and 

one utilizes multiple contract 

pharmacies to supplement an in-house 

pharmacy. All but one of the projects is 

currently ongoing. A condition of 

AMDP approval is the requirement that 

the approved demonstration project be 

audited annually by an independent, 

outside auditor for drug diversion and 

duplicative discounts under Medicaid. 

The results of the audits are required to 

be reported to the Office of Pharmacy 

Affairs (OPA). To date, there has been 

no evidence of drug diversion or 

duplicate manufacturer’s discounts on 

340B drugs in the AMDP program. 

HRSA, acting through OPA, is 

proposing new guidelines that would 

allow covered entities to utilize 

multiple contract pharmacy service sites 

and the utilization of a contract 

pharmacy to supplement in-house 

pharmacy services that were previously 

limited to approved AMDPs. This 

proposed change is due to the success 

of the AMDPs, and the urging of safety 

net providers who wish to utilize 

alternatives to the single entity site/ 

single pharmacy location contractor 

model to provide broader access to 340B 

discounted drugs to eligible patient 

populations. Other than permitting 

these specified models, HRSA is not 

proposing other substantive changes to 

the contract pharmacy guidelines. The 

AMDP process will continue for those 

covered entities wishing to develop 

340B networks of covered entities. OPA 

will continue to review the utilization of 

network demonstration projects and 

consider adapting the rules to include 

them in the future. Of particular 

importance is the continued 

requirement that appropriate procedures 

be in place to prevent diversion of 340B 

drugs or a duplicative 340B drug 

discount and a Medicaid rebate on the 

same drug, which are prohibited under 

the statute. 

These proposed guidelines replace all 

sections of previous 340B Program 

guidance documents addressing nonnetwork contract pharmacy services, 

including, but not limited to, the 

‘‘Notice Regarding Section 602 of the 

Veterans Health Care Act of 1992; 

Contract Pharmacy Services,’’ 61 FR 


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