42900 Federal Register / Vol. 74, No. 163 / Tuesday, August 25, 2009 / Notices 

additional 30 days for public comment. 

The National Institutes of Health may 

not conduct or sponsor, and the 

respondent is not required to respond 

to, an information collection that has 

been extended, revised, or implemented 

on or after October 1, 1995, unless it 

displays a currently valid OMB control 

number. 

Proposed Collection: Title: NIH 

Intramural Research Training Program 

Applications. Type of Information 

Collection Request: Extension of a 

currently approved collection. Need and 

Use of Information Collection: The 

proposed information collection activity 

is necessary in order to determine the 

eligibility and quality of potential 

awardees for traineeships in ten (10) 

NIH intramural research training 

programs. Frequency of Response: On 

occasion. Affected Public: Individuals 

seeking intramural training 

opportunities and references for these 

individuals. Type of Respondents: 

Postdoctoral, predoctoral, 

postbaccalaureate, technical, clinical, 

and student applicants. The annual 

reporting burden is as follows: 

Estimated Number of Respondents: 

67,631; Estimated Number of Responses 

per Respondent: 1.0506; Average 

Burden Hours Per Response: 0.9545; 

and Estimated Total Annual Burden 

Hours Requested: 67,825. The 

annualized cost to respondents is 

estimated at $2,033,085. There are no 

Capital Costs to report. There are no 

Operating or Maintenance Costs to 

report. 

Request for Comments: Written 

comments and/or suggestions from the 

public and affected agencies are invited 

on one or more of the following points: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of the function of the 

agency, including whether the 

information will have practical utility; 

(2) The accuracy of the agency’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 those who 

are to respond, including the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Direct Comments to OMB: Written 

comments and/or suggestions regarding 

the item(s) contained in this notice, 

especially regarding the estimated 

public burden and associated response 

time, should be directed to the: Office 

of Management and Budget, Office of 

Regulatory Affairs, 

OIRA_submission@omb.eop.gov or by 

fax to 202–395–6974, Attention: Desk 

Officer for NIH. To request more 

information on the proposed project or 

to obtain a copy of the data collection 

plans and instruments, contact: Marilyn 

Tuttleman, M.S., Chief, Project 

Clearance Branch, Office of Policy for 

Extramural Research Administration 

(OPERA), OER, OD, NIH, One Rockledge 

Center, Room 3509, 6705 Rockledge 

Drive MSC 7974, Bethesda, MD 20892– 

7983, or call non-toll-free number 301– 

594–7949 or e-mail your request, 

including your address to: 

mtuttleman@mail.nih.gov. 

Comments Due Date: Comments 

regarding this information collection are 

best assured of having their full effect if 

received within 30 days of the date of 

this publication. 

Dated: August 17, 2009. 

Steven Alves, 

Project Officer, OD, OIR, OITE, National 

Institutes of Health. 

[FR Doc. E9–20439 Filed 8–24–09; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–N–0380] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Product 

Jurisdiction: Assignment of Agency 

Component for Review of Premarket 

Applications 

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 procedure by which an applicant 

may obtain an assignment or 

designation determination for 

combination products. 

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: 

Jonna Capezzuto, Office of Information 

Management (HFA–710), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 

JonnaLynn.Capezzuto@fda.hhs.gov, 

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. 


pwalker on DSK8KYBLC1PROD with NOTICES
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 


pwalker on DSK8KYBLC1PROD with NOTICES