Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices 42901 

Product Jurisdiction: Assignment of 

Agency Component for Review of 

Premarket Applications—(OMB Control 

Number 0523)—Extension 

This regulation relates to agency 

management and organization and has 

two purposes. The first is to implement 

section 503(g) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 353(g)), as 

added by the Safe Medical Devices Act 

of 1990 (Public Law 101–629), and 

amended by the Medical Device User 

Fee and Modernization Act of 2002 

(Public Law 107–250), by specifying 

how FDA will determine the 

organizational component within FDA 

assigned to have primary jurisdiction for 

the premarket review and regulation of 

products that are comprised of any 

combination of the following products: 

(1) A drug and a device; (2) a device and 

a biological product; (3) a biological 

product and a drug; or (4) a drug, a 

device, and a biological product. The 

second purpose of this regulation is to 

enhance the efficiency of agency 

management and operations by 

providing procedures for classifying and 

determining which agency component 

is designated to have primary 

jurisdiction for any drug, device, or 

biological product where such 

jurisdiction is unclear or in dispute. 

The regulation establishes a 

procedure by which an applicant may 

obtain an assignment or designation 

determination. The regulation requires 

that the request include the identity of 

the applicant, a comprehensive 

description of the product and its 

proposed use, and the applicant’s 

recommendation as to which agency 

component should have primary 

jurisdiction, with an accompanying 

statement of reasons. The information 

submitted would be used by FDA as the 

basis for making the assignment or 

designation decision. Most information 

required by the regulation is already 

required for premarket applications 

affecting drugs, devices, biological 

products, and combination products. 

The respondents will be businesses or 

other for-profit organizations. 

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 

Part 3 43 1 43 24 1,032 

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

These burden estimates are based on 

the number of applications FDA 

received over the past 2 fiscal years. 

Dated: August 18, 2009. 

David Horowitz, 

Assistant Commissioner for Policy 

[FR Doc. E9–20409 Filed 8–24–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0373] 

Agency Information Collection 

Activities; Proposed Collection; 

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 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 and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the information collection provisions of 

the Mental Models Study of 

Recruitment and Retention of Pregnant 

Women into an Asthma Pregnancy 

Registry. Pregnancy registries are a 

common source of safety information 

about medications used during 

pregnancy. Together with other 

information being collected, FDA will 

use the results from this study to better 

understand how pregnant women and 

their health care providers make 

decisions about participation in 

pregnancy exposure registries. FDA will 

use this new knowledge to develop and 

recommend effective ways to support 

the involvement of health care providers 

and pregnant women in pregnancy 

registries. Ultimately, greater 

involvement of health care providers 

and pregnant women in pregnancy 

registries will improve the quality of 

safety information gathered through the 

registries. Better safety information will 

support informed treatment decisions 

by health care providers and women 

who need prescription medications 

while pregnant. 

DATES: Submit written or electronic 

comments on the collection of 

information by October 26, 2009. 

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: Liz 

Berbakos, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 

Elizabeth.Berbakos@fda.hhs.gov, 301– 

796–3792. 

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 

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 


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42902 Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices 

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. 

Mental Models Study of Recruitment 

and Retention into an Asthma 

Pregnancy Registry 

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 follow up 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 

follow up of all enrolled pregnancies to 

the end of the registry study period. 

Ultimately, high quality human 

pregnancy data gathered through a 

pregnancy registry and incorporated 

into medical product labeling will 

provide patients and their health care 

provider’s 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 Guidance 

for Industry entitled ‘‘Establishing 

Pregnancy Exposure Registries’’ (see 

http://www.fda.gov/downloads/Drugs/ 

GuidanceCompliance

RegulatoryInformation/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. The FDA Office of 

Women’s Health maintains a list of 

current pregnancy registries on its Web 

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

ScienceResearch/SpecialTopics/ 

WomensHealthResearch/ 

ucm134844.htm. FDA regulations (21 

CFR 201.57) describe the content of 

required product labeling for 

prescription drugs. On May 28, 2008, 

FDA proposed major revisions to 

required product labeling to provide 

better information about the effects of 

medicines used during pregnancy. 

Enactment of the Food, Drug and 

Cosmetics Amendments Act of 2007 

gave FDA new legal authority to require 

post-approval 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 decision-making processes of 

a group or groups to a model of the same 

priorities, perceptions, communication 

needs, and decision-making 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 and then 

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 that 

can 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 one-on-one telephone 

discussions with a total of 60 

individuals (20 individuals per cohort) 

from the three 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 


pwalker on DSK8KYBLC1PROD with NOTICES
Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices 42903 

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. 

FDA estimates the burden of this 

collection of information as follows: 

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 

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: August 18, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20407 Filed 8–24–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Peripheral and Central Nervous 

System Drugs Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Peripheral and 

Central Nervous System Drugs Advisory 

Committee. 

General Function of the Committee: To 

provide advice and recommendations to the 

agency on FDA’s regulatory issues. 

Date and Time: The meeting will be held 

on October 14, 2009, from 8 a.m. to 5 p.m. 

Location: The Inn and Conference Center, 

University of Maryland University College 

(UMUC), Marriott Conference Centers, 3501 

University Blvd. East, Adelphi, MD. The 

hotel telephone number is 301–985–7300. 

Contact Person: Diem-Kieu Ngo, Center for 

Drug Evaluation and Research (HFD–21), 

Food and Drug Administration, 5600 Fishers 

Lane (for express delivery, 5630 Fishers 

Lane, rm. 1093), Rockville, MD 20857, 301– 

827–7001, FAX: 301–827–6776, e-mail: 

diem.ngo@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800–741– 

8138 (301–443–0572 in the Washington, DC 

area), code 3014512543. Please call the 

Information Line for up-to-date information 

on this meeting. A notice in the Federal 

Register about last minute modifications that 

impact a previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide timely 

notice. Therefore, you should always check 

the agency’s Web site and call the 

appropriate advisory committee hot line/ 

phone line to learn about possible 

modifications before coming to the meeting. 

Agenda: The committee will discuss new 

drug application (NDA) 22–250, with the 

proposed trade name AMAYA (fampridine) 

10 milligram (mg) tablets, manufactured by 

Acorda Therapeutics, Inc. The proposed 

indication for this new drug product is to 

improve walking ability in individuals with 

multiple sclerosis (MS). MS is a neurological 

disease that may cause a wide variety of 

possible symptoms, including in some 

patients difficulty in walking. 

FDA intends to make background material 

available to the public no later than 2 

business days before the meeting. If FDA is 

unable to post the background material on its 

Web site prior to the meeting, the background 

material will be made publicly available at 

the location of the advisory committee 

meeting, and the background material will be 

posted on FDA’s Web site after the meeting. 

Background material is available at http:// 

www.fda.gov/AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the appropriate 

advisory committee link. 

Procedure: Interested persons may present 

data, information, or views, orally or in 

writing, on issues pending before the 

committee. Written submissions may be 

made to the contact person on or before 

September 29, 2009. Oral presentations from 

the public will be scheduled between 

approximately 1 p.m. and 2 p.m. Those 

desiring to make formal oral presentations 

should notify the contact person and submit 

a brief statement of the general nature of the 

evidence or arguments they wish to present, 

the names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make their 

presentation on or before September 21, 

2009. Time allotted for each presentation 

may be limited. If the number of registrants 

requesting to speak is greater than can be 

reasonably accommodated during the 

scheduled open public hearing session, FDA 

may conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by September 22, 2009. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee meetings 

and will make every effort to accommodate 

persons with physical disabilities or special 

needs. If you require special accommodations 

due to a disability, please contact Diem-Kieu 

Ngo at least 7 days in advance of the meeting. 

FDA is committed to the orderly conduct 

of its advisory committee meetings. Please 

visit our Web site at http://www.fda.gov/ 

AdvisoryCommittees/AboutAdvisory

Committees/ucm111462.htm for procedures 

on public conduct during advisory 

committee meetings. 

Notice of this meeting is given under the 

Federal Advisory Committee Act (5 U.S.C. 

app. 2). 

Dated: August 19, 2009. 

David Horowitz, 

Assistant Commissioner for Policy. 

[FR Doc. E9–20380 Filed 8–24–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0664] 

Oncologic Drugs Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Oncologic Drugs 

Advisory Committee. 


pwalker on DSK8KYBLC1PROD with NOTICES