50030 Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued 

Reporting Activity No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

Total 118 2.39 142 160 10,915 

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

Dated: August 18, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–19626 Filed 8–22–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–N–0087] (formerly 

Docket No. 2007N–0461) 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Mental Models 

Study of Communicating With Health 

Care Providers About the Risks and 

Benefits of Prescription Drug Use for 

Pregnant and Nursing Women With 

Chronic Conditions 

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 September 

24, 2008. 

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: 

202–395–6974, or e-mailed to 

baguilar@omb.eop.gov. All comments 

should be identified with the OMB 

control number 0910–NEW and title, 

‘‘Mental Models Study of 

Communicating with Health Care 

Providers about the Risks and Benefits 

of Prescription Drug Use for Pregnant 

and Nursing Women with Chronic 

Conditions.’’ Also include the FDA 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

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. 

Mental Models Study of 

Communicating With Health Care 

Providers About the Risks and Benefits 

of Prescription Drug Use for Pregnant 

and Nursing Women With Chronic 

Conditions 

The authority for FDA to collect the 

information derives from the FDA 

Commissioner’s authority, as specified 

in section 903(d)(2) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

393(d)(2)). 

The proposed information collection 

will help FDA advance public health by 

identifying misperceptions and 

knowledge gaps about how health care 

providers use information to make 

decisions about the use of prescription 

drugs for the targeted patient groups. 

Knowledge of these misperceptions and 

gaps provides opportunities for FDA to 

target its communications more 

precisely to such gaps and areas of 

misperception in health care providers’

mental models regarding treatment 

decisions. 

FDA engages in various 

communication activities to ensure that 

patients and health care providers have 

the information they need to make 

informed decisions about treatment 

options, including the use of 

prescription drugs. FDA regulations (21 

CFR 201.57) describe the content of 

required product labeling, and FDA 

reviewers ensure that labeling contains 

accurate and complete information 

about the known risks and benefits of 

each drug. This data collection and 

analysis is designed to identify 

knowledge gaps that FDA could then 

address, which would ultimately 

improve decision making and 

potentially improve health outcomes. 

The project will use ‘‘mental 

modeling,’’ a qualitative research 

method that compares a model of the 

decision-making processes of a group or 

groups to an ‘‘expert model’’ of the same 

decision-making processes developed 

from expert knowledge and experience. 

In this study, the decision models of 

certain health care providers concerning 

treatment options for pregnant and 

nursing women will be compared to an 

expert model concerning such treatment 

options that was derived from the 

knowledge and experience of FDA 

reviewers responsible for product 

labeling. FDA will use telephone 

interviews to determine from the health 

care providers the factors that influence 

their treatment decisions for pregnant 

and nursing women with chronic 

conditions. A comparison between 

expert and health care provider models 

based on the collected information may 

identify consequential knowledge gaps 

that can be redressed through messages 

or information campaigns designed by 

FDA. 

Using a protocol derived from the 

research that resulted in the ‘‘expert 

model,’’ trained interviewers will 

conduct one-on-one telephone 

discussions with 24 to 30 members of 

each of 2 categories of health care 

providers (described in the following 

paragraph) who provide health care 

services to pregnant and nursing 

women. 

The two categories of health care 

providers are: 

(1) Those who directly care for 

pregnant and nursing women, including 

obstetricians, OB/GYNs (obstetrician/ 

gynecologists), nurse midwives, and 

primary care practitioners. 

(2) Selected specialties of healthcare 

providers who directly care for women 

of reproductive age who have chronic 

health conditions (allergists, 

psychiatrists, neurologists, and 

cardiologists). 

In the Federal Register of December 

11, 2007 (72 FR 70328), FDA published 

a 60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

FDA estimates the burden of this 

collection of information as follows: 


ebenthall on PRODPC60 with NOTICES
Federal Register / Vol. 73, No. 165 / Monday, August 25, 2008 / Notices 50031 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

60 1 1 1.0 60.0 

1There are no capital costs or operating and maintenance costs for this information collection. 

The study will involve about 60 

respondents and take approximately 1 

hour each to complete. These estimates 

are based on the contractor’s extensive 

experience with mental models 

research. FDA conducted pretests of the 

mental models protocol with six health 

care providers. These resulted in the 

current protocol. 

Dated: August 18, 2008. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E8–19653 Filed 8–22–08; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2008–N–0453] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Regulations Under 

the Federal Import Milk Act 

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 

the reporting and recordkeeping 

requirements of FDA’s regulations 

implementing the Federal Import Milk 

Act (FIMA). 

DATES: Submit written or electronic 

comments on the collection of 

information by October 24, 2008. 

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: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–796–3794. 

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. 

Regulations Under the Federal Import 

Milk Act—21 CFR Part 1210 (OMB 

Control Number 0910–0212)—Extension 

Under FIMA (21 U.S.C. 141–149), 

milk or cream may be imported into the 

United States only by the holder of a 

valid import milk permit (21 U.S.C. 

141). Before such permit is issued: (1) 

All cows from which import milk or 

cream is produced must be physically 

examined and found healthy; (2) if the 

milk or cream is imported raw, all such 

cows must pass a tuberculin test; (3) the 

dairy farm and each plant in which the 

milk or cream is processed or handled 

must be inspected and found to meet 

certain sanitary requirements; (4) 

bacterial counts of the milk at the time 

of importation must not exceed 

specified limits; and (5) the temperature 

of the milk or cream at time of 

importation must not exceed 50° F (21 

U.S.C. 142). 

FDA’s regulations in part 1210 (21 

CFR part 1210) implement the 

provisions of FIMA. Sections 1210.11 

and 1210.14 require reports on the 

sanitary conditions of, respectively, 

dairy farms and plants producing milk 

and/or cream to be shipped to the 

United States. Section 1210.12 requires 

reports on the physical examination of 

herds, while § 1210.13 requires the 

reporting of tuberculin testing of the 

herds. In addition, the regulations in 

part 1210 require that dairy farmers and 

plants maintain pasteurization records 

(§ 1210.15) and that each container of 

milk or cream imported into the United 

States bear a tag with the product type, 

permit number, and shipper’s name and 

address (§ 1210.22). Section 1210.20 

requires that an application for a permit 

to ship or transport milk or cream into 

the United States be made by the actual 

shipper. Section 1210.23 allows permits 

to be granted based on certificates from 

accredited officials. 


ebenthall on PRODPC60 with NOTICES