Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices 8957 

and safety managers, mine foremen, 

maintenance supervisors, production 

coordinators and operators of 

equipment with installed noise controls. 

The proposed time schedule for 

conducting these assessments is before 

installation of a control and on a 

predetermined schedule for the duration 

of the life of the control. For example, 

one noise control may have an expected 

performance life of 6 months. In that 

case the interviews will occur before 

installation, 2 weeks, 6 weeks, 14 

weeks, and 24 weeks post installation. 

Although we plan to follow this 

general time table, due to the nature of 

the mining industry, slight deviation 

may occur. No noise control will require 

greater than 5 interviews per 

respondent. The goal is to achieve 6 

mines and 6 individuals per mine per 

noise control. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondent Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total 

burden 

(in hours) 

Managers Foreman Supervisors Coordinators Operators.Assessment of the Urethane-Coated 

Chain for Continuous Mining Machines.

36 5 20/60 60 

Managers Foreman Supervisors Coordinators Operators.Assessment of the Roof Bolting Machine Noise Control Products.36 5 20/60 60 

Managers Foreman Supervisors Coordinators Operators.Assessment for the Enclosure for 

Vibrating Screen.

36 5 20/60 60 

Total ........................................... ........................................................... 108 ........................ ........................ 180 

Dated: February 22, 2010. 

Maryam I. Daneshvar, 

Acting Reports Clearance Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2010–3999 Filed 2–25–10; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0373] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Mental Models 

Study of Recruitment and Retention of 

Pregnant Women Into An Asthma 

Pregnancy Registry 

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 March 29, 

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–NEW and 

title Mental Models Study of 

Recruitment and Retention of Pregnant 

Women Into An Asthma Pregnancy 

Registry. 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, 301– 

796–3792, 

Elizabeth.Berbakos@fda.hhs.gov. 

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 Recruitment 

and Retention of Pregnant Women Into 

An Asthma Pregnancy Registry—(OMB 

Control Number 0910)—NEW 

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 priorities, perceptions, and 

communication needs about how 

pregnant women and their health care 

providers make decisions about 

participation in a pregnancy registry. 

Understanding these priorities, 

perceptions, and communication needs 

will foster more effective approaches to 

recruitment of pregnant women into 

pregnancy registries and full retention 

of those women until the end of the 

registry study period. Ultimately, early 

enrollment and complete followup of 

women in pregnancy registries will 

strengthen the quality of safety data 

about use of needed medications during 

pregnancy. 

Before a medication is approved by 

FDA for sale in the United States, 

pregnant women are rarely included in 

experimental research studies of the 

medication because of concerns that the 

experimental treatment may harm the 

developing fetus and/or the pregnant 

woman. As a result, when a medication 

is approved for marketing in the United 

States, little systematically collected 

human data are available to define the 

chance of serious side effects in 

pregnant women and/or their 

developing fetuses from use of the 

medication during pregnancy. 

A pregnancy registry is a research 

study conducted after a medication has 

been approved, during which pregnant 

women being treated with the 

medication are observed to identify 

possible harms to the woman and/or to 

her developing fetus. Pregnant women 

voluntarily enroll in a pregnancy 

registry; data about the pregnancy, 

labor, delivery, and newborn are 

collected and analyzed to identify any 

serious adverse outcomes and consider 

whether use of the medication may be 

linked to any observed harm. The 

quality of pregnancy registry data is 

enhanced by enrollment of women early 

in their pregnancy and by complete 

followup of all enrolled pregnancies to 

the end of the registry study period. 

Ultimately, high quality human 


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8958 Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices 

pregnancy data gathered through a 

pregnancy registry and incorporated 

into medical product labeling will 

provide patients and their health care 

providers useful information so they 

may make informed medical treatment 

decisions during pregnancy. Data 

collected from this mental models study 

will be incorporated into 

recommendations for improvement of 

the quality of pregnancy registries, 

ultimately improving medical treatment 

decisions, and potentially improving 

pregnancy outcomes. 

FDA engages in various regulatory 

and communication activities to support 

and at times require collection of safety 

data through establishment of a 

pregnancy registry. Pregnancy exposure 

registries are a major source of human 

pregnancy data for product labeling; 

therefore, FDA is committed to fostering 

ongoing improvements in the design 

and conduct of pregnancy registries. In 

2002, FDA issued a guidance document 

entitled ‘‘Establishing Pregnancy 

Exposure Registries’’ (see http:// 

www.fda.gov/downloads/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/ 

ucm071639.pdf). This guidance 

provides an overview of pregnancy 

exposure registries, describing when 

and how to conduct a pregnancy 

registry about treatment of a disease in 

pregnancy or use of a specific 

medication or group of medications 

during pregnancy. FDA’s Office of 

Women’s Health maintains a list of 

current pregnancy registries on its Web 

site, see http://www.fda.gov/Science

Research/SpecialTopics/WomensHealth

Research/ucm134844.htm. FDA 

regulations (21 CFR 201.57) describe the 

content of required product labeling for 

prescription drugs. In the Federal 

Register of May 29, 2008 (73 FR 30831), 

FDA published a proposed rule to 

amend the agency’s regulations for 

required labeling for drugs and biologics 

when they are used during pregnancy or 

breastfeeding. When finalized, these 

revised regulations will improve 

labeling information about the effects of 

medicines used during pregnancy and 

breastfeeding. Enactment of the Food 

and Drug Administration Amendments 

Act of 2007 gave FDA new legal 

authority to require postapproval 

studies to assess certain safety concerns, 

including, in certain situations, 

establishment of a pregnancy registry. 

Through this data collection and 

analysis, FDA will identify and address 

the perceptions and communication 

needs of pregnant women and health 

care providers to support their 

participation in pregnancy registries. 

The project will use ‘‘mental 

modeling,’’ a qualitative research 

method that compares a model of the 

priorities, perceptions, communication 

needs, and decisionmaking processes of 

a group or groups to a model of the same 

priorities, perceptions, communication 

needs, and decisionmaking processes 

developed from expert knowledge and 

experience. In this study, the decision 

models of women who are current or 

potential participants in a pregnancy 

registry and of health care providers 

who have participated or might 

participate in a pregnancy registry will 

be derived through qualitative 

structured interviews. The project 

focuses on an asthma disease-based 

pregnancy registry; the three cohorts to 

be interviewed are described in detail in 

the following paragraphs. 

Using information gathered from the 

interviews, the decision model about 

pregnancy registry involvement for 

pregnant women and health care 

providers will be developed. Once 

developed, that decision model will be 

compared to decision models about 

pregnancy registry involvement that 

were derived from experts in the fields 

of obstetrical and asthma treatment 

during pregnancy, design and conduct 

of pregnancy registries, FDA medication 

regulation, and biomedical ethics. FDA 

will use telephone interviews with the 

three cohorts to determine the priorities, 

perceptions, communication needs, and 

other factors that influence decisions 

about participation in a pregnancy 

registry by pregnant women and health 

care providers. A comparison between 

an expert model and models based on 

the information collected directly from 

women and health care providers may 

identify consequential perception, 

priority, and communication gaps. 

These critical areas can then be 

redressed through strategic efforts to 

foster involvement in pregnancy 

registries designed by FDA or others. 

Using a protocol derived from the 

research that resulted in the ‘‘expert 

model,’’ trained interviewers will 

conduct 1-on-1 telephone discussions 

with a total of 60 individuals (20 

individuals per cohort) from the 3 

cohorts described here: 

(1) Potential Pregnancy Registry 

Participants: Women older than 18 years 

who are currently being treated for 

asthma and are pregnant or have been 

pregnant within the past 18 months, and 

who may or may not currently be 

participating in a pregnancy registry; 

(2) Current Pregnancy Registry 

Participants: Pregnant women older 

than 18 years who are current 

participants in any pregnancy registry 

for a chronic condition; and 

(3) Health Care Providers: To include 

a mix of health care providers 

(including specialists, obstetriciangynecologists, and primary care 

providers) some who have participated 

in a pregnancy registry and some who 

have not participated in a pregnancy 

registry. 

In the Federal Register of August 25, 

2009 (74 FR 42901), FDA published a 

60-day notice requesting public 

comment on the proposed collection of 

information. One comment was received 

stating that the stakeholder agreed that 

the proposed study was valid and could 

provide information to support 

development of a clinically useful 

pregnancy registry. The stakeholder 

requested information about how 

physicians would be chosen for study 

participation and which subspecialties 

would be represented in the cohort. 

Noting that diversity would be 

beneficial, the comment suggested 

inclusion of physicians practicing in the 

following areas: Allergy/immunology, 

pulmonology, obstetrics and 

gynecology, and primary care. 

FDA’s response is, the Health Care 

Providers (HCPs) cohort for this mental 

models study will include a mix of 

targeted or known HCPs who have 

participated in pregnancy registries, a 

variety of specialists who may or may 

not have participated in pregnancy 

registries, and Ob/Gyn and primary care 

providers who may or may not have 

participated in pregnancy registries. 

Various resources may be used to 

identify a diverse sample of prospective 

primary care and subspecialty HCPs 

who practice in a variety of clinical 

settings. Examples might include 

physicians with privileges at or who 

refer/transfer patient care to tertiary care 

hospitals and HCPs who have contacted 

the Organization for Teratology 

Information Specialists regarding drug 

exposures during pregnancy or about 

pregnancy registry enrollment. The 

cohort of 20 HCPs will be interviewed 

by trained interviewers in 1-on-1 indepth telephone interviews. The 

telephone interactions will take 

approximately 60 minutes and will 

include approximately 45 minutes of 

structured interview. 

FDA estimates the burden of this 

collection of information as follows: 


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Federal Register / Vol. 75, No. 38 / Friday, February 26, 2010 / Notices 8959 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of 

Respondents 

Annual Frequency 

per Response 

Total Annual 

Responses 

Hours per 

Response Total Hours 

60 1 60 1 .0 60 .0 

Total 60 .0 

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

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. 

Dated: February 22, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–3912 Filed 2–25–10; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0083] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Substances 

Prohibited From Use in Animal Food or 

Feed; Animal Proteins Prohibited in 

Ruminant Feed 

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 recordkeeping requirements for this 

collection of information concerning 

substances prohibited from use in 

animal food or feed and animal proteins 

prohibited in ruminant feed. 

DATES: Submit written or electronic 

comments on the collection of 

information by April 27, 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, Office of Information 

Management, Food and Drug 

Administration, 1350 Piccard Dr., P150– 

400B, Rockville, MD 20850, 301–827– 

1472. 

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. 

Substances Prohibited From Use in 

Animal Food or Feed; Animal Proteins 

Prohibited in Ruminant Feed—21 CFR 

589.2000(e)(1)(iv) (OMB Control 

Number 0910–0339)—Extension 

This information collection was 

established because epidemiological 

evidence gathered in the United 

Kingdom suggested that bovine 

spongiform encephalopathy (BSE), a 

progressively degenerative central 

nervous system disease, is spread to 

ruminant animals by feeding protein 

derived from ruminants infected with 

BSE. This regulation places general 

requirements on persons that 

manufacture, blend, process, and 

distribute products that contain or may 

contain protein derived from 

mammalian tissue, and feeds made from 

such products. 

FDA estimates the burden of this 

collection of information as follows: 

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

21 CFR Section No. of 

Recordkeepers 

Annual Frequency per 

Recordkeeping 

Total Annual 

Records 

Hours per 

Records Total Hours 

589.2000(e)(1)(iv) 400 1 400 14 5,600 

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


sroberts on DSKD5P82C1PROD with NOTICES