72202 Federal Register / Vol. 69, No. 238 / Monday, December 13, 2004 / Notices 

Flores v. Reno settlement agreement, 

No. CV85–4544–RJK (C.D. Cal. 1997). 

ORR considers the suitability of a 

sponsor based on the sponsor’s ability 

and agreement to provide for the 

physical, mental and financial wellbeing of an unaccompanied minor and 

the sponsor’s assurance to appear before 

immigration courts. To ensure the safety 

of the children, sponsors must undergo 

a background check. Suitable sponsors 

may be parents, close relatives, friends 

or entities concerned with the child’s 

welfare. In this Notice, ACF announces 

that it proposes to employ the use of 

several information collections for 

recording: (1) The Sponsor’s Agreement 

to Conditions of Release, which collects 

the sponsor’s affirmation to the terms of 

the release; (2) the Verification of 

Release, which collects the children’s 

affirmation to the terms of their release; 

(3) the Family Reunification Packet, 

which collects information related to 

the sponsor’s ability to proved for the 

physical, mental and financial wellbeing of the child(ren); and (4) the 

Authorization for Release of 

Information, which collects information 

to be utilized for a background check.

Respondents: Potential sponsors of 

unaccompanied alien children and 

unaccompanied alien children in 

Federal custody.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents 

Number of

responses per 

respondent 

Average

burden hours 

per response 

Total burden 

hours 

Sponsor’s Agreement ...................................................................................... 3,000 1 .166666 500

Verification of Release ..................................................................................... 3,000 1 .166666 500

Family Reunification Packet ............................................................................ 3,000 20 .05 3,000

Authorization for Release of Information ......................................................... 3,000 12 .05 1,800

Estimated Total Annual Burden Hours ................................................. ........................ ........................ ........................ 5,800

In compliance with the requirements 

of section 3506(c)(2)(A) of the 

Paperwork Reduction Act of 1995, the 

Administration for Children and 

Families is soliciting public comment 

on the specific aspects of the 

information collection described above. 

Copies of the proposed collection of 

information can be obtained and 

comments may be forwarded by writing 

to the Administration for Children and 

Families, Office of Administration, 

Office of Information Services, 370 

L’Enfant Promenade, SW., Washington, 

DC 20447, Attn: ACF Reports Clearance 

Officer. E-mail address: 

grjohnson@acf.hhs.gov. All requests 

should be identified by the title of the 

information collection. 

The Department specifically requests 

comments on: (a) Whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

collection of information on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

Consideration will be given to 

comments and suggestions submitted 

within 60 days of this publication.

Dated: December 6, 2004. 

Robert Sargis, 

Reports Clearance.

[FR Doc. 04–27243 Filed 12–10–04; 8:45 am] 

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004N–0526]

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Guidance for 

Industry: Fast Track Drug 

Development Programs—Designation, 

Development, and Application Review

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 proposed collection of information 

concerning requests for fast track 

designation by sponsors of 

investigational new drugs (INDs) and 

applicants for new drug approvals or 

biological licenses as provided in the 

guidance for industry on fast track drug 

development programs.

DATES: Submit written or electronic 

comments on the collection of 

information by February 11, 2005.

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://www.fda.gov/

dockets/ecomments. 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:

JonnaLynn P. Capezzuto, Office of 

Management Programs (HFA–250), Food 

and Drug Administration, 5600 Fishers 

Lane, Rockville, MD 20857, 301–827–

4659.

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 

Federal Register / Vol. 69, No. 238 / Monday, December 13, 2004 / Notices 72203

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 

comment 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.

Guidance for Industry: Fast Track 

Drug Development Programs—

Designation, Development, and 

Application Review (OMB Control 

Number 0910–0389)—Extension

Section 112(a) of the Food and Drug 

Administration Modernization Act of 

1997 (FDAMA) (Public Law 105–115) 

amended the Federal Food, Drug, and 

Cosmetic Act (the act) by adding section 

506 (21 U.S.C. 356). The section 

authorizes FDA to take appropriate 

action to facilitate the development and 

expedite the review of new drugs, 

including biological products, intended 

to treat a serious or life-threatening 

condition and that demonstrate the 

potential to address an unmet medical 

need. Under section 112(b), FDA issued 

guidance to industry on fast track 

policies and procedures outlined in 

section 506 of the act. The guidance 

discusses collections of information that 

are specified under section 506 of the 

act, other sections of the Public Health 

Service Act (the PHS Act), or 

implementing regulations. The guidance 

describes three general areas involving 

collections of information: (1) Fast track 

designation requests, (2) pre-meeting 

packages, and (3) requests to submit 

portions of an application. Of these, fast 

track designation requests and premeeting packages, in support of 

receiving a fast track program benefit, 

provide for additional collections of 

information not covered elsewhere in 

statute or regulation. Information in 

support of fast track designation or fast 

track program benefits that has 

previously been submitted to the 

agency, may, in some cases, be 

incorporated into the request by 

referring to the information rather than 

resubmitting it.

Under section 506(a)(1) of the act, an 

applicant who seeks fast track 

designation is required to submit a 

request to the agency showing that the 

product meets the statutory standard for 

designation, i.e., that: (1) The product is 

intended for a serious or life-threatening 

condition and (2) the product has the 

potential to address an unmet medical 

need. Mostly, the agency expects that 

information to support a designation 

request will have been gathered under 

existing provisions of the act, the PHS 

Act, or the implementing regulations. If 

such information has already been 

submitted to the agency, the information 

may be summarized in the fast track 

designation request. The guidance 

recommends that a designation request 

include, where applicable, additional 

information not specified elsewhere by 

statute or regulation. For example, 

additional information may be needed 

to show that a product has the potential 

to address an unmet medical need 

where an approved therapy exists for 

the serious or life-threatening condition 

to be treated. Such information may 

include clinical data, published reports, 

summaries of data and reports, and a list 

of references. The amount of 

information and discussion in a 

designation request need not be 

voluminous, but it should be sufficient 

to permit a reviewer to assess whether 

the criteria for fast track designation 

have been met.

After the agency makes a fast track 

designation, a sponsor or applicant may 

submit a pre-meeting package which 

may include additional information 

supporting a request to participate in 

certain fast track programs. As with the 

request for fast track designation, the 

agency expects that most sponsors or 

applicants will have gathered such 

information to meet existing 

requirements under the act, the PHS 

Act, or implementing regulations. These 

may include descriptions of clinical 

safety and efficacy trials not conducted 

under an IND (i.e., foreign studies), and 

information to support a request for 

accelerated approval. The discussion of 

such information in a pre-meeting 

package may be summarized if it has 

already been previously submitted to 

FDA under an OMB approved collection 

of information. Consequently, FDA 

anticipates that the additional collection 

of information solely attributed to the 

guidance will be minimal.

Under section 506(c) of the act, a 

sponsor must submit sufficient clinical 

data for the agency to determine, after 

preliminary evaluation, that a fast track 

product may be effective. Section 506(c) 

also requires that an applicant provide 

a schedule for the submission of 

information necessary to make the 

application complete before FDA can 

commence its review. The guidance 

does not provide for any new collection 

of information regarding the submission 

of portions of an application that is not 

required under section 506(c) or any 

other provision of the act. All forms 

referred to in the guidance have a 

current OMB approval: FDA Forms 1571 

(OMB control number 0910–0014, 

expires September 30, 2002); 356h 

(OMB control number 0910–0338, 

expires March 31, 2003); and 3397 

(OMB control number 0910–0297, 

expires February 29, 2004).

Respondents to this information 

collection are sponsors and applicants 

who seek fast track designation under 

section 506 of the act. The agency 

estimates the total annual number of 

respondents submitting requests for fast 

track designation to the Center for 

Biologics Evaluation and Research 

(CBER) and the Center for Drug 

Evaluation and Research (CDER) will be 

approximately 45. To obtain this 

estimate, FDA averaged the number of 

requests for fast track designation 

received by CBER and CDER in the 3-

year period of 1998 to 2000. For these 

3 years, CBER and CDER together 

received a yearly average of 53 requests 

from 45 respondents. The rate of 

submissions is not expected to change 

significantly in the next few years. FDA 

estimates that the number of hours 

needed to prepare a request for fast track 

designation may range between 40 and 

80 hours per request, depending on the 

complexity of each request, with an 

average of 60 hours per request, as 

indicated in table 1 of this document.

Not all requests for fast track 

designation may meet the statutory 

standard. Of the average 53 requests 

made per year, the agency granted 33 

requests for fast track designation. For 

each of the 33 granted requests, FDA 

estimates that a pre-meeting package 

was submitted to the agency. FDA 

estimates that a pre-meeting package 

needs more preparation time than 

needed for a designation request 

because the issues may be more 

complex and the data may need to be 

more developed. FDA estimates that the 

preparation hours for a pre-meeting 

package may range between 80 and 120 

hours per package, with an average of 

100 hours per package, as indicated in 

table 1 of this document.

FDA estimates the burden of this 

collection of information as follows:

72204 Federal Register / Vol. 69, No. 238 / Monday, December 13, 2004 / Notices 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of

Respondents

Annual Frequency

per Response

Total Annual

Responses

Hours per

Response Total Hours 

Designation Request 45 1.18 53 60 3,180

Pre-meeting Packages 33 1.00 33 100 3,300

Total 6,480

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

Dated: December 6, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–27198 Filed 12–10–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Proposed Collection: 

Comment Request 

In compliance with the requirement 

for opportunity for public comment on 

proposed data collection projects 

(section 3506(c)(2)(A) of Title 44, United 

States Code, as amended by the 

Paperwork Reduction Act of 1995, 

Public Law 104–13), the Health 

Resources and Services Administration 

(HRSA) publishes periodic summaries 

of proposed projects being developed 

for submission to OMB under the 

Paperwork Reduction Act of 1995. To 

request more information on the 

proposed project or to obtain a copy of 

the data collection plans and draft 

instruments, call the HRSA Reports 

Clearance Officer on (301) 443–1129. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of the functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques 

or other forms of information 

technology. 

Proposed Project: State-by-State Self 

Assessment of Trauma Care Systems—

Reinstatement (OMB No. 0915–0259) 

HRSA proposes to collect data from 

the 56 States and Territories on their 

current trauma care systems to assess 

progress since the initial survey in fiscal 

year 2002. This information will be used 

to establish a national strategy to assist 

in future grant opportunities to the 

States to improve or enhance their basic 

systems infrastructure in trauma care 

delivery, as well as their collection and 

usage of quality trauma data. 

HRSA will be collaborating with 

partners from within HRSA’s Healthcare 

Systems Bureau, Division of Healthcare 

Preparedness (DHP), Bioterrorism 

Hospital Preparedness Program; HRSA’s 

Office of Rural Health Policy; and 

HRSA’s Maternal and Child Health 

Bureau. In addition, HRSA will 

collaborate with the Office of Public 

Health Emergency Preparedness; the 

Agency for Healthcare Research and 

Quality; the Centers for Disease Control 

and Prevention’s Center for Injury 

Prevention and Control; the National 

Highway Traffic and Safety 

Administration’s Emergency Medical 

Services (EMS) Division; and affiliated 

professional organizations through the 

DHP Trauma Program’s National 

Trauma-EMS Stakeholder Group. HRSA 

has included national performance 

measures for Trauma/EMS for this 

project in accordance with the 

requirements of the ‘‘Government 

Performance and Results Act (GPRA) of 

1993’’ (Public Law 103–62). This Act 

requires the establishment of 

measurable goals for Federal programs 

that can be reported as part of the 

budgetary process, thus linking funding 

decisions with performance. 

The estimated response burden is as 

follows:

Type of form Number of

respondents 

Responses 

per respondent 

Burden hours 

per response 

Total burden 

hours 

Self Assessment questionnaire ....................................................................... 56 1 10 560 

Total .......................................................................................................... 56 ........................ ........................ 560 

Send comments to Susan G. Queen, 

Ph.D., HRSA Reports Clearance Officer, 

Room 14–33, Parklawn Building, 5600 

Fishers Lane, Rockville, MD 20857. 

Written comments should be received 

within 60 days of this notice.

Dated: November 29, 2004. 

Tina M. Cheatham, 

Director, Division of Policy Review and 

Coordination.

[FR Doc. 04–27199 Filed 12–10–04; 8:45 am] 

BILLING CODE 4165–15–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Indian Health Service 

Loan Repayment Program for 

Repayment of Health Professions 

Educational Loans Announcement 

Type: Initial CFDA Number: 93.164

Dates: Please see Section IV, 3. 

I. Funding Opportunity Description 

The Indian Health Service (IHS) 

estimated budget request for Fiscal Year 

(FY) 2005 includes $12,974,300 for the 

Indian Health Service (IHS) Loan 

Repayment Program (LRP) for health 

professional educational loans 

(undergraduate and graduate) in return 

for full-time clinical service in Indian 

health programs. 

This program announcement is 

subject to the appropriation of funds.