Federal Register / Vol. 75, No. 85 / Tuesday, May 4, 2010 / Notices 23777 

9Cotunga N., C.E. Vickery, K.M. CarpenterHaefele, ‘‘Evaluation of Literacy Level of Patient 

Education Pages in Health-Related Journals,’’ 

Journal of Community Health, 30(3), 213–219, 2005. 

10Andrus, M.R., M.T. Roth, ‘‘Health Literacy: A 

Review,’’ Pharmacotherapy, 22(3), 282–302, 2002. 

FORMAT

Order Drug Facts Minimal Column Column Plus 

Warning first 

Indication first 

The Order manipulation will vary the 

primacy of the boxed warning 

information versus the paragraph about 

the uses to the drug. In terms of Format, 

the Drug Facts format will follow the 

conventions of the existing OTC 

labeling. The Minimal Column 

condition will contain information in 

two columns with only basic 

information in the sections regarding 

information patients should tell their 

doctors. The Column Plus condition 

will also present information in two 

columns, but will include additional 

contextual information in the sections 

about what information patients should 

report to their doctors. 

Participants with relevant medical 

conditions will be randomly assigned to 

one of the six experimental conditions 

and each participant will see only one 

version of the patient information. 

Participants will be prescreened to 

represent a range of health literacy 

levels, including a portion with low 

literacy. Thus, all participants in the 

study will have been diagnosed with 

rheumatoid arthritis, ankylosing 

spondylitis, or plaque psoriasis and at 

least 30 percent of the sample will fall 

in the lower range of literacy. Because 

the average reading level in the United 

States is estimated to be 8th grade9 and 

it is recommended that consumer 

medication information be written at a 

5th grade reading level,10 the low 

literate cohort will consist of consumers 

who have 5th to 8th grade reading skills. 

Education level is not a reliable 

substitute for literacy testing. At 

screening, the participants will be 

assessed for literacy level using a 

validated instrument. 

An additional small study will be 

conducted via the Internet to determine 

whether electronic prototype 

presentation alters the processing of the 

information in any way. Two-hundred 

individuals with the same 

characteristics of the original sample 

(e.g., medical condition and literacy 

levels) will be recruited over the 

Internet and will complete the same 

questionnaire as original participants. 

FDA is undertaking this study 

because it does not yet have sufficient 

evidence-based research relating to 

patient needs, or whether those needs 

are being effectively met. Research 

related to the functionality and 

effectiveness of written patient 

information consistently identifies the 

importance of performance-based 

testing as well as content based testing, 

which enables the evaluation of 

materials in order to assure their utility 

and identify issues in content format, or 

design. Development of new 

prescription drug patient materials must 

be based on consumer testing that 

focuses on utility to the patient and 

comprehension of material in the 

broadest audience possible. FDA has 

developed three prototypes in order to 

user test prescription drug information 

with consumers in order to achieve this 

goal. For further information, contact 

Elizabeth Berbakos (see FOR FURTHER

INFORMATION CONTACT). 

The burden table reflects up to three 

pretests of 180 individuals each, 900 

participants in the main study, and 200 

participants in the followup study 

involving electronic administration. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR Section No. of Respondents Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

540 1 540 20/60 178 

900 1 900 25/60 369 

200 1 200 25/60 82 

Total 629 

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

Dated: April 28, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10359 Filed 5–3–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0190] 

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 

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23778 Federal Register / Vol. 75, No. 85 / Tuesday, May 4, 2010 / Notices 

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 July 6, 2010. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http:// 

www.regulations.gov. 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: 

Denver Presley, Jr., Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., PI50– 

400B, Rockville, MD 20850, 301–796– 

3793. 

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 parts 

106 and 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), FDA 

proposed changes in the infant formula 

regulations, including some of those 

listed in tables 1, 2, and 3 of this 

document. The document 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

Federal Food, Drug, and Cosmetic Act or 21 CFR Section No. of 

Respondents 

Annual Frequency 

per 

Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

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

21 CFR 106.120(b) 1 1 1 4 4 

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

21 CFR 107.50(e)(2) 1 1 1 4 4 

Total 682 

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

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 50 400 20,000 

107.50 (c)(3) 3 10 30 300 9,000 

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Federal Register / Vol. 75, No. 85 / Tuesday, May 4, 2010 / Notices 23779 

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1—Continued 

21 CFR 

Section 

No. of 

Recordkeepers 

Annual Frequency 

per 

Recordkeeping 

Total Annual 

Records 

Hours per 

Record Total Hours 

Total 29,000 

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

TABLE 3.—THIRD PARTY DISCLOSURE REQUIREMENTS1

21 CFR Section No. of 

Respondents 

Annual Frequency 

of Disclosure 

Total Annual 

Disclosures 

Hours per 

Disclosure Total Hours 

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

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. All infant formula submissions 

to FDA may be provided in electronic 

format. The hours per response 

reporting estimates are based on FDA’s 

experience with similar programs and 

information received from industry. 

FDA estimates that it will receive 13 

reports from 5 manufacturers annually 

under section 412(d) of the act, for a 

total annual response of 65 reports. Each 

report is estimated to take 10 hours per 

response for a total of 650 hours. FDA 

also estimates that it will receive one 

notification under § 106.120(b). The 

notification is expected to take 4 hours 

per response, for a total of 4 hours. 

For exempt infant formula, FDA 

estimates that it will receive two reports 

from three manufacturers annually 

under § 107.50(b)(3) and (b)(4), for a 

total annual response of six reports. 

Each report is estimated to take 4 hours 

per response for a total of 24 hours. FDA 

also estimates that it will receive one 

notification under § 107.50(e)(2). The 

notification is expected to take 4 hours 

per response, for a total of 4 hours. 

FDA estimates that 5 firms will 

expend approximately 20,000 hours per 

year to fully satisfy the record keeping 

requirements in § 106.100. It is 

estimated that 3 firms will expend 

approximately 9,000 hours per year to 

fully satisfy the record keeping 

requirements in § 107.50(c)(3). 

FDA estimates that compliance with 

the labeling requirements of §§ 107.10(a) 

and 107.20 will require 520 hours 

annually by 5 manufacturers. 

Dated: April 28, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–10360 Filed 5–3–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0507] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Requirements for 

Submission of Labeling for Human 

Prescription Drugs and Biologics in 

Electronic Format 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing 

that a proposed collection of 

information has been submitted to the 

Office of Management and Budget 

(OMB) for review and clearance under 

the Paperwork Reduction Act of 1995. 

DATES: Fax written comments on the 

collection of information by June 3, 

2010. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be faxed to the Office of 

Information and Regulatory Affairs, 

OMB, Attn: FDA Desk Officer, FAX: 

202–395–7285, or e-mailed to 

oira_submission@omb.eop.gov. All 

comments should be identified with the 

OMB control number 0910–0530. Also 

include the FDA docket number found 

in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Elizabeth Berbakos, Office of 

Information Management, Food and 

Drug Administration, 1350 Piccard Dr., 

PI50–400B, Rockville, MD 20850, 

Elizabeth.Berbakos@fda.hhs.gov, 301– 

796–3792. 

SUPPLEMENTARY INFORMATION: In 

compliance with 44 U.S.C. 3507, FDA 

has submitted the following proposed 

collection of information to OMB for 

review and clearance. 

Requirements for Submission of 

Labeling for Human Prescription Drugs 

and Biologics in Electronic Format— 

OMB Control Number 0910–0530— 

Extension 

FDA is requesting that OMB extend 

approval under the Paperwork 

Reduction Act (44 USC 3501–3520) for 

the information collection resulting 

from the requirement that the content of 

labeling for prescription drug products 

be submitted to FDA electronically in a 

form that FDA can process, review, and 

archive. This requirement was set forth 

in the final rule entitled ‘‘Requirements 

for Submission of Labeling for Human 

Prescription Drugs and Biologics in 

Electronic Format’’ (December 11, 2003; 

68 FR 69009), which amended FDA 

regulations governing the format in 

which certain labeling is required to be 

submitted for FDA review with new 

drug applications (NDAs) (21 CFR 

314.50(l)(1)(i)), including supplemental 

NDAs, abbreviated new drug 

applications (ANDAs) (21 CFR 

314.94(d)(1)(ii)), including 

supplemental ANDAs, and annual 

reports (21 CFR 314.81(b)(2)(iii)(b)) (the 

final rule also applied to certain 

Biologics License Applications, but the 

information collection for these 

requirements is not part of this OMB 

approval request). 

This OMB approval request is only for 

the burden associated with the 

electronic submission of the content of 

labeling. The burden for submitting 

labeling as part of NDAs, ANDAs, 

supplemental NDAs and ANDAs, and 

annual reports, has been approved by 

OMB under Control Number 0910–0001. 

When we last requested that OMB 

extend approval for this information 

collection (see the Federal Register of 

March 29, 2006 (71 FR 15752)), we 

received several comments. Generally, 

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