34188 Federal Register / Vol. 63, No. 120 /Tuesday, June 23, 1998 / Notices

Washington, DC 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 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: June 17, 1998.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 98–16627 Filed 6–22–98; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–0436]

Asahi Denka Kogyo K.K.; Filing of

Food Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that Asahi Denka Kogyo K.K. has filed

a petition proposing that the food

additive regulations be amended to

provide for the expanded safe use of

2,2′-methylenebis(4,6-di-tertbutylphenyl)2-ethylhexyl phosphite as

an antioxidant and/or stabilizer in high

density polyethylene articles intended

for contact with food.

FOR FURTHER INFORMATION CONTACT:

Andrew J. Zajac, Center for Food Safety

and Applied Nutrition (HFS–15), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3095.

SUPPLEMENTARY INFORMATION: Under the

Federal Food, Drug, and Cosmetic Act

(sec. 409(b)(5) (21 U.S.C. 348(b)(5))),

notice is given that a food additive

petition (FAP 8B4599) has been filed by

Asahi Denka Kogyo K.K., c/o Japan

Technical Information Center, Inc., 775

S. 23d St., Arlington, VA 22202. The

petition proposes to amend the food

additive regulations in § 178.2010

Antioxidants and/or stabilizers for

polymers (21 CFR 178.2010) to provide

for the expanded safe use of 2,2′-

methylenebis(4,6-di-tert-butylphenyl)2-

ethylhexyl phosphite as an antioxidant

and/or stabilizer in high density

polyethylene articles intended for

contact with food.

The agency has determined under 21

CFR 25.32(i) that this action is of the

type that does not individually or

cumulatively have a significant effect on

the human environment. Therefore,

neither an environmental assessment

nor an environmental impact statement

is required.

Dated: June 11, 1998.

Laura M. Tarantino,

Acting Director, Office of Premarket

Approval, Center for Food Safety and Applied

Nutrition.

[FR Doc. 98–16622 Filed 6–22–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 77N–0240]

Erythrityl Tetranitrate; Drug Efficacy

Study Implementation; Revocation of

Exemption; Opportunity for a Hearing

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is revoking the

temporary exemption that has allowed

single-entity coronary vasodilator drug

products containing erythrityl

tetranitrate to remain on the market

beyond the time limits scheduled for

implementation of the Drug Efficacy

Study. FDA is announcing that the

products lack substantial evidence of

effectiveness and is offering an

opportunity for a hearing on a proposal

to withdraw approval of any applicable

new drug applications (NDA’s) or

abbreviated new drug applications

(ANDA’s).

DATES: The revocation of exemption is

effective June 23, 1998; requests for

hearings are due on or before July 23,

1998; data in support of hearing

requests are due on or before August 24,

1998.

ADDRESSES: Communications in

response to this notice should be

identified with the reference number

DESI 1786 and directed to the attention

of the appropriate office named below.

A request for a hearing, supporting

data, and other comments are to be

identified with Docket No. 77N–0240

and submitted to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

A request for an opinion on

applicability of this notice to a specific

product should be directed to the

Division of Prescription Drug

Compliance and Surveillance (HFD–

330), Center for Drug Evaluation and

Research, Food and Drug

Administration, 7500 Standish Pl.,

Rockville, MD 20855.

FOR FURTHER INFORMATION CONTACT:

Mary E. Catchings, Center for Drug

Evaluation and Research (HFD–7), Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–594–

2041.

SUPPLEMENTARY INFORMATION:

I. Background

Under the agency’s Drug Efficacy

Study Implementation (DESI) program,

the National Academy of Sciences/

National Research Council (NAS/NRC)

evaluated the effectiveness of certain

coronary vasodilators. Based on NAS/

NRC’s recommendations, FDA classified

the coronary vasodilators as probably

and possibly effective for indications

relating to the management,

prophylaxis, or treatment of anginal

attacks. This classification was

announced in the Federal Register of

February 25, 1972 (37 FR 4001).

In a notice published in the Federal

Register of December 14, 1972 (37 FR

26623), as amended July 11, 1973 (38 FR

18477), August 26, 1977 (42 FR 43127),

October 21, 1977 (42 FR 56156), and

September 15, 1978 (43 FR 41282), FDA

temporarily exempted the single-entity

coronary vasodilators covered by the

DESI program from the time limits

established for completing the program

(Paragraph XIV, Category I exemption).

FDA granted this exemption to allow

manufacturers additional time to

conduct clinical studies to determine

effectiveness of the drugs for prevention

of anginal attacks. In the August 26,

1977, notice, FDA added certain dosage

forms of erythrityl tetranitrate (not

included in the Drug Efficacy Study but

regarded as related drugs) to the

Paragraph XIV, Category I exemption.

The exemption notices established

conditions for marketing the singleentity coronary vasodilators pending

FDA’s conclusions about the products.

FDA required that each manufacturer

conduct bioavailability studies on its

own product(s) and that at least one

manufacturer conduct clinical

effectiveness studies for each chemical

entity to which the same effectiveness

conclusions would ultimately apply. An
Federal Register / Vol. 63, No. 120 /Tuesday, June 23, 1998 / Notices 34189

ANDA was required for marketing of

products not the subject of an NDA;

such products were to be conditionally

approved, pending the results of

ongoing studies. Conditionally

approved ANDA’s were given the same

status as the ‘‘deemed approved’’ NDA’s

under review in the DESI program, i.e.,

safe but not proven effective (42 FR

43127 and 43129).

The following applications for

erythrityl tetranitrate received

conditional approval under the terms of

the exemption notices:

1. ANDA 86–194; Cardilate Chewable

Tablets containing 10 milligrams (mg)

erythrityl tetranitrate per tablet; Glaxo

Wellcome (formerly Burroughs

Wellcome), 3030 Cornwallis Rd., P.O.

Box 12700, Research Triangle Park, NC

27709–2700.

2. ANDA 86–203; Cardilate Tablets

containing 5, 10, or 15 mg of erythrityl

tetranitrate per tablet; Glaxo Wellcome.

In response to the exemption notices,

the then Burroughs Wellcome Co.

submitted efficacy data on its erythrityl

tetranitrate products, but later requested

in separate letters that FDA withdraw

approval of ANDA’s 86–194 and 86–

203, stating that the marketing of the

products had been discontinued. FDA

withdrew approval of ANDA 86–194 in

the Federal Register of February 13,

1996 (61 FR 5562 at 5563). FDA

considers the requests for withdrawal of

the ANDA’s to also constitute requests

for withdrawal of the efficacy data.

Accordingly, FDA is now proposing to

withdraw approval of the applications

based on lack of substantial evidence of

effectiveness.

II. Revocation of Exemption

According to FDA’s records, no

person other than Glaxo Wellcome has

submitted data or expressed an

intention to perform clinical studies on

single-entity erythrityl tetranitrate, and

it is now reclassified to lacking

substantial evidence of effectiveness.

The temporary exemption, as it pertains

to the drug, is revoked.

No other single-entity coronary

vasodilators remain exempt under the

Paragraph XIV, Category I exemption,

and Category I is now dissolved.

III. Notice of Opportunity for a Hearing

On the basis of all the data and

information available to her, the

Director of the Center for Drug

Evaluation and Research is unaware of

any adequate and well-controlled

clinical investigation, conducted by

experts who are qualified by scientific

training and experience, meeting the

requirements of section 505 of the

Federal Food, Drug, and Cosmetic Act

(the act)(21 U.S.C. 355) and 21 CFR

314.126, that demonstrates effectiveness

of single-entity erythrityl tetranitrate.

Notice is given to the holder of any

NDA or ANDA for single-entity

erythrityl tetranitrate, to manufacturers

or distributors of the drug, and to all

other interested persons, that the

Director of the Center for Drug

Evaluation and Research proposes to

issue an order under section 505(e) of

the act withdrawing approval of any

NDA or ANDA and all amendments and

supplements thereto providing for

single-entity erythrityl tetranitrate and

its indication relating to the

management, prophylaxis, or treatment

of anginal attacks. The Director of the

Center for Drug Evaluation and Research

finds that new information before her

with respect to the drug, evaluated

together with the evidence available to

her when applications were approved

under the exempting notices, shows that

there is a lack of substantial evidence

that the drug will have the effect it

purports or is represented to have under

the conditions of use prescribed,

recommended, or suggested in the

labeling.

This notice applies to any person who

manufactures or distributes a drug

product containing single-entity

erythrityl tetranitrate that is not the

subject of an approved NDA and that is

identical, related, or similar as defined

in § 310.6 (21 CFR 310.6). It is the

responsibility of every drug

manufacturer or distributor to review

this notice to determine whether it

covers any drug product that the person

manufactures or distributes. Any person

may request an opinion of the

applicability of this notice to a specific

drug product by writing to the Division

of Prescription Drug Compliance and

Surveillance (address above).

This notice of opportunity for a

hearing encompasses all issues relating

to the legal status of the drug products

subject to it (including identical,

related, or similar drug products as

defined in § 310.6), e.g., any contention

that any such product is not a new drug

because it is generally recognized as safe

and effective within the meaning of

section 201(p) of the act (21 U.S.C.

321(p)) or because it is exempt from part

or all of the new drug provisions of the

act under the exemption for products

marketed before June 25, 1938, in

section 201(p) of the act, or under

section 107(c) of the Drug Amendments

of 1962 (Pub. L. 87–781), or for any

other reason.

In accordance with section 505 of the

act and the regulations issued under it

(21 CFR parts 310 and 314), an

applicant and all other persons subject

to this notice are hereby given a

opportunity for a hearing to show why

approval of any applicable NDA’s or

ANDA’s should not be withdrawn.

An applicant or any other person

subject to this notice who decides to

seek a hearing shall file: (1) On or before

July 23, 1998, a written notice of

appearance and request for a hearing,

and (2) on or before August 24, 1998,

the data, information, and analyses

relied on to demonstrate that there is a

genuine issue of material fact to justify

a hearing, as specified in § 314.200. Any

other interested person may also submit

comments on this notice. The

procedures and requirements governing

this notice of opportunity for a hearing,

a notice of appearance and request for

a hearing, information and analyses to

justify a hearing, other comments, and

a grant or denial of a hearing are

contained in §§ 314.150 and 314.200,

and in 21 CFR part 12.

The failure of an applicant or any

other person subject to this notice to file

a timely written notice of appearance

and request for a hearing, as required by

§ 314.200, constitutes an election by that

person not to use the opportunity for a

hearing concerning the action proposed

and a waiver of any contentions

concerning the legal status of that

person’s drug product(s). Any new drug

product marketed without an approved

NDA is subject to regulatory action at

any time.

A request for a hearing may not rest

upon mere allegations or denials, but

must present specific facts showing that

there is a genuine and substantial issue

of fact that requires a hearing. If it

conclusively appears from the face of

the data, information, and factual

analyses in the request for a hearing that

there is no genuine and substantial issue

of fact which precludes the withdrawal

of approval of the application, or when

a request for a hearing is not made in

the required format or with the required

analyses, the Commissioner of Food and

Drugs will enter summary judgment

against the person(s) who requests the

hearing, making findings and

conclusions, and denying a hearing.

All submissions pursuant to this

notice of opportunity for a hearing are

to be filed in four copies. Except for data

and information prohibited from public

disclosure under 21 U.S.C. 331(j) or 18

U.S.C. 1905, the submissions may be

seen in the Dockets Management Branch

(address above) between 9 a.m. and 4

p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(sec. 505 (21 U.S.C. 355)) and under

authority delegated to the Director of the
34190 Federal Register / Vol. 63, No. 120 /Tuesday, June 23, 1998 / Notices

Center for Drug Evaluation and Research

(21 CFR 5.70 and 5.82).

Dated: May 28, 1998.

Janet Woodcock,

Director, Center for Drug Evaluation and

Research.

[FR Doc. 98–16578 Filed 6–22–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Health Care Financing Administration

Statement of Organization, Functions,

and Delegations of Authority

Part F, of the Statement of

Organization, Functions, and

Delegations of Authority of the

Department of Health and Human

Services, Health Care Financing

Administration (HCFA), 49 FR 34247,

dated September 6, 1984, is amended to

include the following delegation of

authority from the Secretary to the

Administrator, HCFA, for carrying out

Title XXVII, of the Public Health Service

Act, as amended.

• Section F.30., Delegations of

Authority is amended by adding the

following paragraph.

UU. The authority vested in the

Secretary by Title XXVII of the Public

Health Service Act, as amended by the

Health Insurance Portability and

Accountability Act of 1986, Public Law

104–191.

This delegation shall be exercised

under the Department’s policy on

regulations. In addition, I hereby affirm

and ratify any actions taken by the

Administrator or other HCFA officials

which, in effect, involved the exercise of

this authority prior to the effective date

of this delegation.

This delegation is effective

immediately.

Dated: June 11, 1998.

Donna E. Shalala,

Secretary.

[FR Doc. 98–16592 Filed 6–22–98; 8:45 am]

BILLING CODE 4120–07–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

National Institutes of Health

Proposed Collection; Comment

Request; Biologic Specimen-Based

Study of Dietary Measurement Error

for Nutritional Epidemiology and

Surveillance

SUMMARY: In compliance with the

requirement of Section 3506(c)(2)(A) of

the Paperwork Reduction Act of 1995

for opportunity for public comment on

proposed data collection projects, the

National Institutes of Health (NIH),

National Cancer Institute (NCI) will

publish periodic summaries of proposed

projects to be submitted to the Office of

Management and Budget (OMB) for

review and approval.

Proposed Collection

Title: Biologic specimen-based study

of dietary measurement error for

nutritional epidemiology and

surveillance. Type of Information

Collection Request: New. Need and use

of Information Collection: The agency

conducts and funds studies examining

the relationship between diet and

chronic diseases. The study will collect,

on a sample of 400 free-living men and

women, 40–69 years of age, two 24-hour

dietary recalls, two food frequency

questionnaires, a physical activity

questionnaire, a dietary screener

questionnaire, and an opinion form.

Respondents will receive a dose of

doubly labeled water and provide spot

urine samples to measure energy

expenditure, will collect two 24-hour

urines to measure urinary nitrogen, and

provide blood samples to measure

biochemical measures of dietary intake.

The data will be used to assess the

magnitude and structure of dietary

measurement error in dietary

surveillance and nutritional

epidemiologic studies. Frequency of

response: One-time study. Affected

public: Individuals or households.

Types of Respondents: U.S. adults 40–

69 years of age. The annual reporting

burden is as follows:

Data collection

Estimated

number of

respondents

Estimated

number of

responses

per respondent

Average burden hours

per response

Estimated

total hour

burden

Estimated

total annual

burden

hours

requested

Screener ................................................................................................. 400 1 0.167 67 67

24-hour recall #1 ..................................................................................... 400 1 .5 200 200

24-hour recall #2 ..................................................................................... 400 1 .5 200 200

Food frequency questionnaire #1 ........................................................... 400 1 1 400 400

Food frequency questionnaire #2 ........................................................... 400 1 1 400 400

Physical activity questionnaire ................................................................ 400 1 .25 100 100

Opinion forms ......................................................................................... 400 1 .25 100 100

Dietry screener questionnaire ................................................................. 400 1 .167 67 67

Dosing with DLW/initial urine collections ................................................ 400 1 4 1600 1600

Spot urine collections ............................................................................. 400 1 0.25 100 100

Spot hr urine collection #1 ...................................................................... 400 1 .167 67 67

24-hr urine collection #2 ......................................................................... 400 1 .167 67 67

Blood collection ....................................................................................... 400 1 .25 100 100

Total ............................................................................................. 400 1 .67 3,468 3,468

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 proposed performance

of the functions of the agency, including

whether the information shall 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.