27090 Federal Register / Vol. 63, No. 94 / Friday, May 15, 1998 / Notices

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: May 11, 1998.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 98–12914 Filed 5–14–98; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

[Program Announcement No: CB 98–03]

Announcement of the Availability of

Financial Assistance and Request for

Applications for Fiscal Year 1998 to

Support Child Welfare Training

Projects as Authorized by Section 426

of the Social Security Act, as

Amended. 42 U.S.C. 626, CFDA: 93.648

AGENCY: Children’s Bureau,

Administration on Children, Youth and

Families (ACF/DHHS).

ACTION: Notice of fiscal year 1998 Child

Welfare Training Project priorities,

availability of financial assistance, and

request for applications to support Child

Welfare Training Projects as authorized

by section 426 of the Social Security

Act, as Amended. 42 U.S.C. 626, CFDA:

93.648.

SUMMARY: The Children’s Bureau,

Administration on Children, Youth and

Families, ACF, announces the

availability of FY 1998 funds for

competing new discretionary grants to

public or other non-profit institutions of

higher learning for special projects for

training of personnel for work in the

field of child welfare.

Federal funds for Child Welfare

Training Project Priorities are available

for: (1) professional education for public

child welfare practitioners; (2) training

for the frontline public child welfare

agency staff in the use of the Statewide

Automated Child Welfare Information

Systems (SACWIS); and (3) training for

child protective and child welfare

services staff for collaboration with

community-based agencies to provide

services to at-risk families to prevent

child abuse and neglect.

DEADLINE DATE: The closing time and

date for the receipt of applications

under this announcement is 4:30 p.m.

(Eastern Time Zone), on July 20, 1998.

Applications received after 4:30 p.m. of

the closing date will be classified as

late. Post marks and other similar

documents DO NOT establish receipt of

an application.

ADDRESSES: Mailing and Delivery

Instructions: Mailed applications and

applications delivered by overnight/

express mail services shall be

considered as meeting the announced

deadline if they are received on or

before the deadline receipt date,

between the hours of 8:00 a.m. and 4:30

p.m. (Eastern Time Zone) and sent to

the Administration on Children, Youth

and Families (ACYF) Operations Center,

1225 Jefferson Davis Hwy, Suite 415,

Arlington, VA 22202. The telephone

number is 1–800–351–2293. Any

application received after the deadline

time and date will not be considered for

competition.

Hand Delivered Applications,

Applicant Couriers: If applications hand

delivered by applicants or applicant

couriers are received on or before the

deadline date between the hours of 8:00

a.m. and 4:30 p.m. (Eastern Time Zone)

at the Administration on Children,

Youth and Families (ACYF) Operations

Center, 1225 Jefferson Davis Hwy, Suite

415, Arlington, VA 22202, they shall be

considered as meeting the announced

deadline.

Electronic Transmissions: ACF cannot

accommodate transmission of

applications by fax or through other

electronic media. Therefore,

applications transmitted to ACF

electronically will not be accepted

regardless of date or time of submission

and time of receipt.

Late Applications: Applications

which do not meet the criteria above are

considered late applications. ACF shall

notify each late applicant that its

application will not be considered in

the current competition.

Extension of Deadlines: ACF may

extend the deadline for all applicants

because of acts of God such as floods,

hurricanes, etc., or when there is a

widespread disruption of the mail

system. However, if ACF does not

extend the deadline for all applicants, it

may not waive or extend the deadline

for any applicants.

Program Announcement Requests:

Copies of the program announcement

may obtained by contacting the

Administration on Children, Youth and

Families (ACYF) Operations Center,

1225 Jefferson Davis Hwy, Suite 415,

Arlington, VA 22202. The telephone

number is 1–800–351–2293. Copies of

this announce will be automatically sent

to all universities with accredited

undergraduate and graduate social work

programs. A copy of this program

announcement is also located at the

Children’s Bureau website at http://

www.acf.dhhs.gov/program/cb.

SUPPLEMENTARY INFORMATION: Grant

awards of FY 1998 funds will be made

by September 30, 1998. Under this

announcement, approximately $2

million is available for the new awards.

The announcement provides

information regarding the funding level

for each priority area. Applicants should

note that the number of grants to be

awarded under this program

announcement are subject to the

availability of funds.

Catalog of Federal Domestic Assistance

The Catalog of Federal Domestic Assistance

(CFDA) number of the Child Welfare

Training Grants is 93.648.

Dated: May 11, 1998.

James A. Harrell,

Deputy Commissioner Administration on

Children, Youth and Families.

[FR Doc. 98–12979 Filed 5–14–98; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0268]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

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

FDA’s patent term restoration

regulations on due diligence petitions

for regulatory review period revision.

DATES: Submit written comments on the

collection of information by July 14,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–
Federal Register / Vol. 63, No. 94 / Friday, May 15, 1998 / Notices 27091

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857. 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

Information Resources Management

(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

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 listed below.

With respect to the following

collection of information, FDA invites

comments on: (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.

Patent Term Restoration, Due Diligence

Petitions, Filing, Format, and Content of

Petitions—Part 60 (21 CFR Part 60)

(OMB control number 0910–0233—

Extension)

FDA’s patent extension activities are

conducted under the authority of the

Drug Price Competition and Patent

Term Restoration Act of 1984 and the

Animal Drug and Patent Term

Restoration Act of 1988 (35 U.S.C. 156).

New human drug, animal drug, human

biological, medical device, food

additive, or color additive products

regulated by FDA must undergo FDA

safety, or safety and effectiveness

review, before marketing is permitted.

Where the product is covered by a

patent, part of the patent’s term may be

consumed during this review, which

diminishes the value of the patent. In

enacting 35 U.S.C. 156, Congress sought

to encourage development of new, safer,

and more effective medical and food

additive products. It did so by

authorizing the U.S. Patent and

Trademark Office (PTO) to extend the

patent term by a portion of the time

during which FDA’s safety and

effectiveness review prevented

marketing of the product. The length of

the patent term extension is generally

limited to a maximum of 5 years, and

is calculated by PTO based on a

statutory formula. When a patent holder

submits an application for patent term

extension to PTO, PTO requests

information from FDA, including the

length of the regulatory review period

for the patented product. If PTO

concludes that the product is eligible for

patent term extension, FDA publishes a

notice which describes the length of the

regulatory review period, and the dates

used to calculate that period. Interested

parties may request, under § 60.24,

revision of the length of the regulatory

review period, or may petition, under

§ 60.30, to reduce the regulatory review

period by any time where marketing

approval was not pursued with ‘‘due

diligence.’’ The statute defines due

diligence as ‘‘that degree of attention,

continuous directed effort, and

timeliness as may reasonably be

expected from, and are ordinarily

exercised by, a person during a

regulatory review period.’’ As provided

in § 60.30(c), a due diligence petition

‘‘shall set forth sufficient facts,

including dates if possible, to merit an

investigation by FDA of whether the

applicant acted with due diligence.’’

Upon receipt of a due diligence petition,

FDA reviews the petition and evaluates

whether any change in the regulatory

review period is necessary. If so, the

corrected regulatory review period is

published in the Federal Register. A

due diligence petitioner not satisfied

with FDA’s decision regarding the

petition may, under § 60.40, request an

informal hearing for reconsideration of

the due diligence determination.

Petitioners are likely to include persons

or organizations having knowledge that

FDA’s marketing permission for that

product was not actively pursued

throughout the regulatory review

period. The information collection for

which an extension of approval is being

sought is the use of the statutorily

created due diligence petition.

Since 1992, five requests for revision

of the regulatory review period have

been submitted under § 60.24. One

regulatory review period has been

altered. No due diligence petitions have

been submitted to FDA, under § 60.30,

and consequently there have been no

requests for hearings, under § 60.40,

regarding the decisions on such

petitions.

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

60.24(a) 1 1 1 100 100

60.30 0 0 0 0 0

60.40 0 0 0 0 0

1There are no capital costs or operating and maintenance costs associated with this collection of information.
27092 Federal Register / Vol. 63, No. 94 / Friday, May 15, 1998 / Notices

Dated: May 7, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–12897 Filed 5–14–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0456]

Agency Information Collection

Activities; Announcement of OMB

Approval

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Conditions for the Use of Narcotic

Drugs for Treatment of Narcotic

Addiction, Reporting and

Recordkeeping Requirements,’’ has been

approved by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act of 1995 (the PRA).

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: In the

Federal Register of November 25, 1997

(62 FR 62773), the agency announced

that the proposed information collection

had been submitted to OMB for review

and clearance under section 3507 of the

PRA (44 U.S.C. 3507). An agency may

not conduct or sponsor, and a person is

not required to respond to, a collection

of information unless it displays a

currently valid OMB control number.

OMB has now approved the information

collection and has assigned OMB

control number 0910–0140. The

approval expires on April 30, 2001.

Dated: May 7, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–12902 Filed 5–14–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0287]

Guidance for Industry on Buspirone

Hydrochloride Tablets In Vivo

Bioequivalence and In Vitro

Dissolution Testing; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance for industry

entitled ‘‘Buspirone Hydrochloride

Tablets In Vivo Bioequivalence and In

Vitro Dissolution Testing.’’ This is

revision 1 of the guidance. The guidance

has been revised to reflect the recent

availability of buspirone hydrochloride

tablets in 15-milligram dosage forms.

Bioequivalence is tested using the

highest available dosage of the reference

listed drug. The revised guidance also

notes the nonlinearity of buspirone at

multiple-dosing.

DATES: Written comments on agency

guidance documents may be submitted

at any time.

ADDRESSES: Copies of this guidance for

industry are available on the Internet at

‘‘http://www.fda.gov/cder/guidance/

index.htm’’. Submit written requests for

single copies of ‘‘Buspirone

Hydrochloride Tablets In Vivo

Bioequivalence and In Vitro Dissolution

Testing’’ to the Drug Information Branch

(HFD–210), Center for Drug Evaluation

and Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that

office in processing your requests.

Submit written comments on this

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Sikta Pradhan, Center for Drug

Evaluation and Research (HFD–652),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–5847.

SUPPLEMENTARY INFORMATION: This

guidance document is a level 2 guidance

document consistent with FDA’s good

guidance practices (62 FR 8961,

February 27, 1997). It represents the

agency’s current thinking on buspirone

hydrochloride tablets in vivo

bioequivalence and in vitro dissolution

testing. It does not create or confer any

rights for or on any person and does not

operate to bind FDA or the public. An

alternative approach may be used if

such approach satisfies the requirement

of the applicable statute, regulations, or

both.

Interested persons may submit written

comments on the guidance at any time

to the Dockets Management Branch

(address above). Two copies of any

comments are to be submitted, except

that individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. The guidance

and received comments are available for

public examination in the Dockets

Management Branch between 9 a.m. and

4 p.m., Monday through Friday

Dated: May 8, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–12903 Filed 5–14–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D–0276]

Guidance for Industry on Standards for

the Prompt Review of Efficacy

Supplements, Including Priority

Efficacy Supplements; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance for industry

entitled ‘‘Standards for the Prompt

Review of Efficacy Supplements,

Including Priority Efficacy

Supplements.’’ As required by the Food

and Drug Administration Modernization

Act of 1997 (Modernization Act), this

guidance for industry describes the

standards for the prompt review of

efficacy supplements. It also is intended

to define those efficacy supplements

that are eligible for priority review.

DATES: Written comments may be

submitted on the guidance document by

August 13, 1998. General comments on

agency guidance documents are

welcome at any time.

ADDRESSES: Copies of this guidance for

industry are available on the Internet at

http://www.fda.gov/cder/guidance/

index.htm, or http://www.fda.gov/cber/

guidelines.htm. Submit written

comments on this guidance to the

Dockets Management Branch (HFD–

305), Food and Drug Administration,