Federal Register / Vol. 63, No. 95 / Monday, May 18, 1998 / Notices 27299

12862 in the Administration for

Children and Families.

OMB No. 0980–0266.

Description: Under the provisions of

the Federal Paperwork Reduction Act of

1995 (Pub. L. 104–13), the

Administration for Children and

Families (ACF) is requesting clearance

for instruments to implement Executive

Order 12862 within the ACF. The

purpose of the data collection is to

obtain customer satisfaction information

from those entities who are funded to be

our partners in the delivery of services

to the American public. ACF partners

are those entities that receive funding to

deliver services or assistance from ACF

programs. Examples of partners are

States and local governments,

territories, service providers, Indian

Tribes and Tribal organizations,

grantees, researchers, or other

intermediaries serving target

populations identified by and funded

directly or indirectly by ACF. The

surveys will obtain information about

how well ACF is meeting the needs or

our partners in operating the ACF

programs.

Respondents: State, Local, Tribal

Govt. or Not-for-Profit Institutions

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of responses per

respondent

Average burden hours per

response

Total burden

hours

State Governments ........................................................................................... 51 10 1 510

Head Start grantees & Delegates .................................................................... 200 1 .5 100

Other Discretionary Grant Programs ................................................................ 200 10 .5 1,000

Indian Tribes & tribal Organizations ................................................................. 25 10 .5 50

Estimated Total Annual Burden Hours: 1,660

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 in

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 Information Services,

Division of Information Resource

Management Services, 370 L’Enfant

Promenade S.W., Washington, D.C.

20447, Attn: ACF Reports Clearance

Officer. 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 qualify, utility, and clarify of the

information to be collected; and (d)

ways to minimize the burden of the

collection on information on

respondents, including through the use

of automated collection techniques or

other forms on information technology.

Consideration will be given to

comments and suggestions submitted

within 60 days of this publication.

Dated: May 13, 1998.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 98–13112 Filed 5–15–98; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0513]

Agency Information Collection

Activities; Orphan Drugs: Submission

for OMB Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by June 17,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attention: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1472.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collection of information to OMB for

review and clearance.

Orphan Drugs—21 CFR Part 316—

(OMB No. 0910–0167—Reinstatement)

Sections 525 through 528 of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 360aa through

360dd), give FDA statutory authority to:

(1) Provide recommendations on

investigations required for approval of

marketing applications for orphan

drugs; (2) designate eligible drugs as

orphan drugs; (3) set forth conditions

under which a sponsor of an approved

orphan drug obtains exclusive approval;

and (4) encourage sponsors to make

orphan drugs available for treatment on

an ‘‘open protocol’’ basis before the drug

has been approved for general

marketing. The implementing

regulations for these statutory

requirements have been codified under

part 316 (21 CFR part 316) and specify

procedures that sponsors of orphan

drugs use in availing themselves of the

incentives provided for orphan drugs in

the act and set forth procedures FDA

will use in administering the act with

regard to orphan drugs. Section 316.10

specifies the content and format of a

request for written recommendations

concerning the nonclinical laboratory

studies and clinical investigations

necessary for approval of marketing

applications. Section 316.12 provides

that, before providing such

recommendations, FDA may require

results of studies to be submitted for

review. Section 316.14 contains

provisions permitting FDA to refuse to

provide written recommendations under

certain circumstances. Within 90 days

of any refusal, a sponsor may submit

additional information specified by

FDA. Section 316.20 specifies the

content and format of an orphan drug
27300 Federal Register / Vol. 63, No. 95 / Monday, May 18, 1998 / Notices

application which includes

requirements that an applicant

document that the disease is rare (affects

fewer than 200,000 persons in the

United States annually) or that the

sponsor of the drug has no reasonable

expectation of recovering costs of

research and development of the drug.

Section 316.26 allows an applicant to

amend the application under certain

circumstances. Section 316.30 requires

submission of annual reports, including

progress reports on studies, a

description of the investigational plan,

and a discussion of changes that may

affect orphan status. The information

requested will provide the basis for an

FDA determination that the drug is for

a rare disease or condition and satisfies

the requirements for obtaining ophan

drug status. Secondly, the information

will describe the medical and regulatory

history of the drug. The respondents to

this collection of information are

biotechnology firms, drug companies,

and academic clinical researchers. 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

316.10, 316.12, and 316.14 0 0 0 0 0

316.20, 316.21, and 316.26 90 1.78 160.20 125 20,025

316.22 5 1 5 2 10

316.27 5 1 5 4 20

316.30 450 1 450 2 900

316.36 .2 3 .6 15 9

Total Burden Hours .......................... .......................... .......................... .......................... 20,964

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

The information requested from

respondents represents, for the most

part, an accounting of information

already in possession of the applicant.

It is estimated, based on the frequency

of requests over the past 5 years, that 90

persons or organizations per year will

request orphan drug designation and

that no requests for recommendations

on design of preclinical or clinical

studies will be received. Based upon

FDA experience over the last decade,

FDA estimates that the effort required to

prepare applications to receive

consideration for sections 525 and 526

of the act (§§ 316.10, 316.12, 316.20, and

316.21) is generally similar and is

estimated to require an average of 95

hours of professional staff time and 30

hours of support staff time per

application. Estimates of annual activity

and burden for foreign sponsor

nomination of a resident, agent, change

in ownership or designation, and

inadequate supplies of drug in

exclusivity, are based on total

experience by FDA with such requests

since 1983.

Dated: May 8, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–13042 Filed 5–15–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0286]

Environmental Assessments and

Findings of No Significant Impact

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that it has reviewed environmental

assessments (EA’s) and issued findings

of no significant impact (FONSI’s)

relating to the 167 new drug

applications (NDA’s) and supplemental

applications listed in this document.

FDA is publishing this notice because

Federal regulations require public

notice of the availability of

environmental documents.

ADDRESSES: The EA’s and FONSI’s may

be seen in the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857, or a

copy may be requested by writing the

Freedom of Information Staff (HFI–35),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Nancy B. Sager, Center for Drug

Evaluation and Research (HFD–357),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–594–5629.

SUPPLEMENTARY INFORMATION: Under the

National Environmental Policy Act of

1969 (NEPA), Congress declared that it

will be the continuing policy of the

Federal Government to ‘‘use all

practicable means and measures,

including financial and technical

assistance, in a manner calculated to

foster and promote the general welfare,

to create and maintain conditions under

which man and nature can exist in

productive harmony, and fulfill the

social, economic and other requirements

of present and future generations of

Americans.’’ (See 42 U.S.C. 4331(a).)

NEPA requires all Federal agencies to

include in every proposal for major

Federal actions significantly affecting

the quality of the human environment,

a detailed statement assessing the

environmental impact of, and

alternatives to, the proposed action and

to make available to the public such

statements. (See 42 U.S.C. 4332, 40 CFR

1506.6, and 21 CFR 25.51(b).)

FDA implements NEPA through its

regulations in part 25 (21 CFR part 25).

Under those regulations, actions to

approve NDA’s, abbreviated new drug

applications (ANDA’s), and

supplements to existing approvals

ordinarily require the preparation of an

EA. (See § 25.20(l).)

FDA approved 167 NDA’s and

supplemental NDA’s and ANDA’s for

the products listed in the following

table: