Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 / Notices 41859

goals of the OPD Grant Program

described in section I (Program Research

Goals) of this document.

D. Award Criteria

Resources for this program are

limited. Therefore, two or more

applications should be received and

approved by FDA which propose

duplicative or very similar studies, FDA

will support only the study with the

best score.

VI. Submission Requirements

The original and five copies of the

completed Grant Application Form PHS

398 (Rev. 5/95) or the original and two

copies of the PHS 5161 (Rev. 7/92) for

State and local governments, with

copies of the appendices for each of the

copies, should be delivered to Robert L.

Robins (address above). State and local

governments may choose to use the PHS

398 application form in lieu of the PHS

5161. The application receipt date is

November 2, 1998. No supplemental or

addendum material will be accepted

after the receipt date. Evidence of final

IRB approval will be accepted for the

file after the receipt date.

The outside of the mailing package

and item 2 of the application face page

should be labeled, ‘‘Response to RFA

FDA OPD–99’’.

If an application for the same study

was submitted in response to a previous

RFA, but has not yet been acted upon,

a submission in response to this RFA

will be considered a request to

withdraw the previous application.

Resubmissions are treated as new

applications; therefore, the applicant

may wish to address the issues

presented in the summary statements

from the previous review.

VII. Method of Application

A. Submission Instructions

Applications will be accepted during

normal working hours, 8 a.m. to 4:30

p.m., Monday through Friday, on or

before the established receipt date.

Applications will be considered

received on time if sent or mailed on or

before the receipt date as evidenced by

a legible U.S. Postal Service dated

postmark or a legible date receipt from

a commercial carrier, unless they arrive

too late for orderly processing. Private

metered postmarks shall not be

acceptable as proof of timely mailing.

Applications not received on time will

not be considered for review and will be

returned to the applicant. (Applicants

should note that the U.S. Postal Service

does not uniformly provide dated

postmarks. Before relying on this

method, applicants should check with

their local post office.)

Do not send applications to the Center

for Scientific Research (CSR), National

Institutes of Health (NIH). Any

application that is sent to NIH, that is

then forwarded to FDA and received

after the applicable due date, will be

deemed unresponsive and returned to

the applicant. Instructions for

completing the application forms can be

found on the NIH home page on the

Internet (address ‘‘http://www.nih.gov/

grants/funding/phs398/phs398.html’’;

the forms can be found at ‘‘http://

www.nih.gov/grants/funding/phs398/

formsltoc.html’’). However, as noted

previously, applications are not to be

mailed to NIH. Applicants are advised

that FDA does not adhere to the page

limitations or the type size and line

spacing requirements imposed by the

NIH on its applications). Applications

must be submitted via mail delivery as

stated above. FDA is unable to receive

applications via the Internet.

B. Format for Application

Submission of the application must be

on Grant Application Form PHS 398

(Rev. 5/95). All ‘‘General Instructions’’

and ‘‘Specific Instructions’’ in the

application kit should be followed with

the exception of the receipt date and the

mailing label address. Do not send

applications to CSR, NIH. Applications

from State and local governments may

be submitted on Form PHS 5161 (Rev.

7/92) or Form PHS 398 (Rev. 5/95).

The face page of the application

should reflect the request for

applications number RFA–FDA–OPD–

99. The title of the proposed study

should include the name of the product

and the disease/disorder to be studied

along with the IND/IDE number. The

format for all subsequent pages of the

application should be double-spaced

and single-side.

Data included in the application, if

restricted with the legend specified

below, may be entitled to confidential

treatment as trade secret or confidential

commercial information within the

meaning of the Freedom of Information

Act (5 U.S.C. 552(b)(4)) and FDA’s

implementing regulations (21 CFR

20.61).

Information collection requirements

requested on Form PHS 398 and the

instructions have been submitted by

PHS to the Office of Management and

Budget (OMB) and were approved and

assigned OMB control number 0925–

0001.

C. Legend

Unless disclosure is required by the

Freedom of Information Act as amended

(5 U.S.C. 552) as determined by the

freedom of information officials of

DHHS or by a court, data contained in

the portions of this application which

have been specifically identified by

page number, paragraph, etc., by the

applicant as containing restricted

information shall not be used or

disclosed except for evaluation

purposes.

Dated: July 29, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20825 Filed 8–4–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96E–0270]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; ETOPOPHOS

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

ETOPOPHOS and is publishing this

notice of that determination as required

by law. FDA has made the

determination because of the

submission of an application to the

Commissioner of Patents and

Trademarks, Department of Commerce,

for the extension of a patent which

claims that human drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–6620.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

and the Generic Animal Drug and Patent

Term Restoration Act (Pub. L. 100–670)

generally provide that a patent may be

extended for a period of up to 5 years

so long as the patented item (human

drug product, animal drug product,

medical device, food additive, or color

additive) was subject to regulatory

review by FDA before the item was

marketed. Under these acts, a product’s

regulatory review period forms the basis
41860 Federal Register / Vol. 63, No. 150 /Wednesday, August 5, 1998 / Notices

for determining the amount of extension

an applicant may receive.

A regulatory review period consists of

two periods of time: A testing phase and

an approval phase. For human drug

products, the testing phase begins when

the exemption to permit the clinical

investigations of the drug becomes

effective and runs until the approval

phase begins. The approval phase starts

with the initial submission of an

application to market the human drug

product and continues until FDA grants

permission to market the drug product.

Although only a portion of a regulatory

review period may count toward the

actual amount of extension that the

Commissioner of Patents and

Trademarks may award (for example,

half the testing phase must be

subtracted as well as any time that may

have occurred before the patent was

issued), FDA’s determination of the

length of a regulatory review period for

a human drug product will include all

of the testing phase and approval phase

as specified in 35 U.S.C. 156(g)(1)(B).

FDA recently approved for marketing

the human drug product ETOPOPHOS

(etoposide phosphate). ETOPOPHOS

is indicated for the management of the

following neoplasms: Refractory

testicular tumors and small cell lung

cancer. Subsequent to this approval, the

Patent and Trademark Office received a

patent term restoration application for

ETOPOPHOS (U.S. Patent No.

4,904,768) from Bristol-Myers Squibb

Co., and the Patent and Trademark

Office requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

July 8, 1997, FDA advised the Patent

and Trademark Office that this human

drug product had undergone a

regulatory review period and that the

approval of ETOPOPHOS represented

the first permitted commercial

marketing or use of the product. Shortly

thereafter, the Patent and Trademark

Office requested that FDA determine the

product’s regulatory review period.

FDA has determined that the

applicable regulatory review period for

ETOPOPHOS is 1,719 days. Of this

time, 1,029 days occurred during the

testing phase of the regulatory review

period, 690 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 505(b) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 355(b)) became effective:

September 4, 1991. FDA has verified the

applicant’s claim that the date the

investigational new drug application

became effective was on September 4,

1991.

2. The date the application was

initially submitted with respect to the

human drug product under section

505(b) of the act: June 28, 1994. FDA

has verified the applicant’s claim that

the new drug application (NDA) for

ETOPOPHOS (NDA 20–457) was

initially submitted on June 28, 1994.

3. The date the application was

approved: May 17, 1996. FDA has

verified the applicant’s claim that NDA

20–457 was approved on May 17, 1996.

This determination of the regulatory

review period establishes the maximum

potential length of a patent extension.

However, the U.S. Patent and

Trademark Office applies several

statutory limitations in its calculations

of the actual period for patent extension.

In its application for patent extension,

this applicant seeks 1,017 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before October 5, 1998, submit to

the Dockets Management Branch

(address above) written comments and

ask for a redetermination. Furthermore,

any interested person may petition FDA,

on or before February 1, 1999, for a

determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period. To meet its burden, the petition

must contain sufficient facts to merit an

FDA investigation. (See H. Rept. 857,

part 1, 98th Cong., 2d sess., pp. 41–42,

1984.) Petitions should be in the format

specified in 21 CFR 10.30.

Comments and petitions should be

submitted to the Dockets Management

Branch (address above) in three copies

(except that individuals may submit

single copies) and identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: July 8, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health

Affairs.

[FR Doc. 98–20826 Filed 8–4–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Resources and Services

Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Health Resources

and Services Administration (HRSA)

publishes abstracts of information

collection requests under review by the

Office of Management and Budget, in

compliance with the Paperwork

Reduction Act of 1995 (44 U.S.C.

Chapter 35). To request a copy of the

clearance requests submitted to OMB for

review, call the HRSA Reports

Clearance Office on (301) 443–1129.

The following request has been

submitted to the Office of Management

and Budget for review under the

Paperwork Reduction Act of 1995:

Proposed Project: The Knowledge of

Ryan White Providers About ACTG076

NEW—The HIV/AIDS Bureau (HAB)

intends to conduct a survey of

approximately 305 health care providers

who work in Ryan White IIIb funded

programs and who treat women of

childbearing age. The specific topic area

of this study relates to perinatal

transmission of HIV.

The purpose of this survey is to

determine:

—The specific training and learning

needs of providers in Ryan White

funded programs with regard to HIV/

AIDS issues (especially perinatal

transmission of HIV) and women of

childbearing age.

—The preferred modes of training.

—The level of knowledge of, and

adherence to, Government protocols

for treating women of childbearing

age and reducing the risk of perinatal

transmission of HIV.

—The familiarity of practitioners with

recent advances in HIV/AIDS

treatments such as protease inhibitors

and combined therapies.

Results from this research will be

used to develop specific training

curricula for these providers and to

enhance educational and service

delivery-related support for Bureaufunded providers and clinics.

The study will be a self-administered

mail survey, with phone follow-up if

necessary to improve response rates.

The estimated respondent burden is

as follows: