Federal Register / Vol. 63, No. 102 /Thursday, May 28, 1998 / Notices 29229

interested in funding ‘‘wish lists’’ of

business possibilities. ANA expects

written evidence of the solid investment

of time and consideration on the part of

the applicant with regard to the

development of business plans.

Business plans should be developed

based on market analysis and feasibility

studies regarding the potential success

to the business prior to the submission

of the application.

• Core administration functions, or

other activities, which essentially

support only the applicant’s on-going

administrative functions.

• Project goals which are not

responsive to one or more of the funding

competitive areas.

• Projects that will not be completed,

self-sustaining, or supported by other

than ANA funds, at the end of the

project period.

• Project goals which are not

responsive to one or more of the funding

competitive areas.

• Projects that will not be completed,

self-sustaining, or supported by other

than ANA funds, at the end of the

project period.

• ANA will not fund investment

capital for purchase or takeover of an

existing business, for purchase or

acquisition of a franchise, or for

purchase of stock or other similar

investment instruments.

• Renovation or alteration unless it is

essential for the project. Renovation or

alteration costs may not exceed the

lesser of $150,000 or 25 percent of the

total direct costs approved for the entire

budget period.

• Projects originated and designed by

consultants who provide a major role for

themselves in the proposed project and

are not members of the applicant

organization.

I. Paperwork Reduction Act of 1995

(Pub. L. 104–13)

Public reporting burden for this

collection of information is estimated to

average 29.5 hours per response,

including the time for reviewing

instructions, gathering and maintaining

the data needed, and reviewing the

collection of information.

The following information collections

are included in the program

announcement: ANA grant applications,

OMB control number 0980–0204,

expires August 31, 1999.

An agency may conduct or sponsor,

and a person is not required to respond

to, collection of information unless it

displays a currently valid OMB control

number.

J. Receipt of Applications

Applications must either be hand

delivered or mailed to the address in

Section F, The Application Process:

Application Submission. The

Administration for Native Americans

cannot accommodate transmission of

applications by fax or through other

electronic media. Therefore,

applications transmitted to ANA

electronically will not be accepted

regrdless of date or time of submission

and time of receipt. Videotapes and

cassette tapes may not be included as

part of a grant application for panel

review.

Applications and related materials

postmarked after the closing date will be

classified as late; and not considered in

the current competition.

1. Deadlines

• Mailed applications shall be

considered as meeting an announced

deadline if they are either received on

or before the deadline date or sent on or

before the deadline date and received by

ACF in time for the independent review

to: U.S. Department of Health and

Human Services, Administration for

Children and Families, Division of

Discretionary Grants, 370 L’Enfant

Promenade, SW., Mail Stop 6C–462,

Washington, D.C. 20447.

• Applicants are cautioned to request

a legibly dated U.S. Postal Service

postmark or to obtain a legibly dated

receipt from a, commercial carrier or the

U.S. Postal Service. Private metered

postmarks shall not be acceptable as

proof of timely mailing.

• Applications hand carried by

applicants, applicant couriers, or by

overnight/express mail couriers shall be

considered as meeting an announced

deadline if they are received on or

before the deadline date or postmarked

on or before the deadline date, Monday

through Friday (excluding Federal

holidays), between the hours of 8:00 am

and 4:30 pm at: U.S. Department of

Health and Human Services,

Administration for Children and

Families, Division of Discretionary

Grants, ACF Mailroom, 2nd Floor

Loading Dock, Aerospace Center, 901 D

Street, SW., Washington, DC 20024.

(Applicants are cautioned that express/

overnight mail services do not always

deliver as agreed.)

• 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.

• No additional material will be

accepted, or added to an application,

unless it is postmarked by the deadline

date.

2. 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.

3. Extension of Deadlines

The Administration for Children and

Families may extend an application

deadline for applicants affected by acts

of God such as floods and hurricanes, or

when there is a widespread disruption

of the mails. A determination to extend

or waive deadline requirements rests

with the Chief Grants Management

Officer.

(Catalog of Federal Domestic Assistance

Program Numbers: 93:612 Native American

Programs)

Dated: May 22, 1998.

Gary N. Kimple,

Commissioner, Administration for Native

Americans.

[FR Doc. 98–14132 Filed 5–27–98; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0304]

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

reinstatement of an existing collection

of information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

requirements governing applications for

FDA approval to market a new drug.

DATES: Submit written comments on the

collection of information by July 27,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,
29230 Federal Register / Vol. 63, No. 102 /Thursday, May 28, 1998 / Notices

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:

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: 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 reinstatement

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 set forth in this document.

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.

Applications for FDA Approval to

Market a New Drug—21 CFR Part

314—(OMB Control Number 0910–

0001)—Reinstatement

Under section 505(a) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 355(a)), a new drug may not

be commercially marketed in the United

States, imported, or exported from the

United States, unless an approval of an

application filed with FDA under

section 505(b) or (j) of the act is effective

with respect to such drug. Section

505(b) and (j) of the act requires a

sponsor to submit to FDA a new drug

application (NDA) containing, among

other things, full reports of

investigations that show whether or not

the drug is safe and effective for use, a

full list of articles used as components

in the drug, a full description of

manufacturing methods, samples of the

drugs required, specimens of the

labeling proposed to be used, and

certain patent information as applicable.

Under the act, it is the sponsor’s

responsibility to provide the

information needed by FDA to make a

scientific and technical determination

that the product is safe and effective.

This information collection approval

request is for all information

requirements imposed on sponsors by

the regulations under part 314 (21 CFR

part 314) , who apply for approval of a

NDA in order to market or to continue

to market a drug.

The following sections in part 314 set

forth the specific format and content

requirements for NDA’s.

Section 314.50(a) requires that an

application form (Form FDA 356h) must

be submitted that includes basic

introductory information about the drug

as well as a checklist of enclosures.

(Section 314.50(a) is already approved

by OMB under 0910–0338 and is not

included in the hour burden estimates

in Table 1 of this document.)

Section 314.50(b) requires that an

index must be submitted with the

archival copy of the application and that

it must reference certain sections of the

application.

Section 314.50(c) requires that a

summary of the application must be

submitted that presents a good general

synopsis of all the technical sections

and other information in the

application.

Section 314.50(d) requires that the

NDA contain the following technical

sections about the new drug: Chemistry,

manufacturing, and controls;

nonclinical pharmacology and

toxicology; human pharmacokinetics

and bioavailability; microbiology;

clinical data; and statistical section.

Section 314.50(e) requires that the

applicant must submit samples of the

drug if requested by FDA. In addition,

the archival copy of the application

must include copies of the label and all

labeling for the drug.

Section 314.50(f) requires that case

report forms and tabulations must be

submitted with the archival copy.

Section 314.50(h) requires that patent

information as described under § 314.53

must be submitted with the application.

(Section 314.50(h) is already approved

by OMB under 0910–0305 and is not

included in the hour burden estimates

in Table 1 of this document.)

Section 314.50(i) requires that a

patent certification information must be

submitted in 505(b)(2) applications for

patents claiming the drug, drug product,

method of use, or method of

manufacturing. (Section 314.50(i) is

already approved by OMB under 0910–

0305 and is not included in the hour

burden estimates in Table 1 of this

document.)

Section 314.50(j) requires that

applicants that request a period of

marketing exclusivity must submit

certain information with the

application. (Section 314.50(j) is already

approved by OMB under 0910–0305 and

is not included in the hour burden

estimates in Table 1 of this document.)

Section 314.50(k) requires that an

archival, review, and field copy of the

application must be submitted.

Section 314.52 requires that notice of

certification of invalidity or

noninfringement of a patent to patent

holders and NDA holders must be sent

by 505(b)(2) applicants and must follow

certain content and notification

procedures. (Section 314.52 is already

approved by OMB under 0910–0305 and

is not included in the hour burden

estimates in Table 1 of this document.)

Section 314.54 sets forth the content

requirements for applications filed

under section 505(b)(2) of the act.

Section 314.60 sets forth reporting

requirements for sponsors who amend

an unapproved application.

Section 314.65 states that the sponsor

must notify FDA when withdrawing an

unapproved application.

Sections 314.70 and 314.71 require

that supplements must be submitted to

FDA for certain changes to an approved

application.

Section 314.72 requires sponsors to

report to FDA any transfer of ownership

of an application.

Section 314.80(c)(1) and (c)(2) sets

forth requirements for expedited

adverse drug experience postmarketing

reports and followup reports, as well as

for periodic adverse drug experience

postmarketing reports (Form FDA

3500A). (Section 314.80(c)(1) and (c)(2)

is already approved by OMB under

0910–0230 and 0910–0291 and is not

included in the hour burden estimates

in Table 1 of this document.)

Section 314.80(c)(1)(iii) and (i)

establishes recordkeeping requirements

for reports of postmarketing adverse

drug experiences. (Section

314.80(c)(1)(iii) and (i) is already

approved by OMB under 0910–0230

and 0910–0291 and is not included in

the hour burden estimates in Table 1 of

this document.)
Federal Register / Vol. 63, No. 102 /Thursday, May 28, 1998 / Notices 29231

Section 314.81(b)(1) requires that field

alert reports must be submitted to FDA

(Form FDA 3331).

Section 314.81(b)(2) requires that

annual reports must be submitted to

FDA (Form FDA 2252).

Section 314.81(b)(3)(i) requires that

drug advertisements and promotional

labeling must be submitted to FDA

(Form FDA 2253). (Section

314.81(b)(3)(i) is already approved by

OMB in ‘‘Transmittal of Advertisements

and Promotional Labeling for Drugs and

Biologics for Human Use,’’ which

published in the Federal Register of

October 24, 1997 (62 FR 55408), and is

not included in the hour burden

estimates in Table 1 of this document.)

Section 314.81(b)(3)(iii) sets forth

reporting requirements for sponsors

who withdraw an approved drug

product from sale. (Section

314.81(b)(3)(iii) is already approved by

OMB under 0910–0045 and is not

included in the hour burden estimates

in Table 1 of this document).

Section 314.90 sets forth requirements

for sponsors who request waivers from

FDA for compliance with §§ 314.50

through 314.81. (The information

collection hour burden estimate for

NDA waiver requests is included in

Table 1 of this document under

estimates for §§ 314.50, 314.60, 314.70,

and 314.71.)

Section 314.93 sets forth requirements

for submitting a suitability petition in

accordance with 21 CFR 10.20 and

10.30. (Section 314.93 is already

approved by OMB under 0910–0183 and

is not included in the hour burden

estimates in Table 1 of this document.)

The following sections in part 314 set

forth requirements when submitting an

abbreviated new drug application

(ANDA).

Section 314.94(a) and (d) requires that

an ANDA must contain the following

and information: Application form;

table of contents; basis for ANDA

submission; conditions of use; active

ingredients; route of administration,

dosage form, and strength;

bioequivalence; labeling; chemistry,

manufacturing, and controls; samples;

and patent certification.

Section 314.95 requires that notice of

certification of invalidity or

noninfringement of a patent to patent

holders and NDA holders must be sent

by ANDA applicants. (Section 314.95 is

already approved by OMB under 0910–

0305 and is not included in the hour

burden estimates in Table 1 of this

document.)

Section 314.96 sets forth requirements

for amendments to an unapproved

application.

Section 314.97 sets forth requirements

for submitting supplements to an

approved ANDA for changes that

require FDA approval.

Section 314.98(a) sets forth

postmarketing adverse drug experience

reporting and recordkeeping

requirements. (Section 314.98(a) is

already approved by OMB under 0910–

0230 and 0910–0291 and is not

included in the hour burden estimates

in Table 1 of this document.)

Section 314.98(c) requires other

postmarketing reports: Field alert

reports (Form FDA 3331), annual

reports (Form FDA 2252), and

advertisements and promotional

labeling (Form FDA 2253). (The

information collection hour burden

estimate for field alert reports is

included in Table 1 of this document

under § 314.81(b)(1); the estimate for

advertisements and promotional

labeling is included under

§ 314.81(b)(3)(i).)

Section 314.99(a) requires that

sponsors must comply with certain

reporting requirements for withdrawing

an unapproved ANDA and for a change

in ownership of an ANDA.

Section 314.99(b) sets forth

requirements for sponsors who request

waivers from FDA for compliance with

§§ 314.92 through 314.99. (The

information collection hour burden

estimate for ANDA waiver requests is

included in Table 1 of this document

under estimates for §§ 314.94(a) and (d),

314.96, and 314.97.)

Section 314.101(a) requires that, if

FDA refuses to file an application, the

applicant may request an informal

conference with FDA and request that

the application be filed over protest.

Section 314.107(c)(4) requires notice

to FDA by ANDA or 505(b)(2)

application holders of any legal action

concerning patent infringement.

(Section 314.107(c)(4) is already

approved by OMB under 0910–0305 and

is not included in the hour burden

estimates in Table 1 of this document.)

Section 314.107(e)(2)(iv) requires that

an applicant must submit a copy of the

entry of the order or judgement to FDA

within 10 working days of a final

judgement. (Section 314.107(e)(2)(iv) is

already approved by OMB under 0910–

0305 and is not included in the hour

burden estimates in Table 1 of this

document.)

Section 314.107(f) requires that an

ANDA or 505(b)(2) applicants must

notify FDA of the filing of any legal

action filed within 45 days of receipt of

the notice of certification. A patent

owner may also notify FDA of the filing

of any legal action for patent

infringement. The patent owner or

approved application holder who is an

exclusive patent licensee must submit to

FDA a waiver that waives the

opportunity to file a legal action for

patent infringement. (Section 314.107(f)

is already approved by OMB under

0910–0305 and is not included in the

hour burden estimates in Table 1 of this

document.)

Section 314.110(a)(3) and (a)(4)

requires after receipt of an FDA

approvable letter, an applicant may

request an opportunity for a hearing on

the question of whether there are

grounds for denying approval of the

application. (Section 314.110(a)(3) and

(a)(4) is included under the parts 10

through 16 (21 CFR part 10 through 16)

hearing regulations, in accordance with

§ 314.201, and is not included in the

hour burden estimates in Table 1 of this

document.)

Section 314.110(a)(5) requires that,

after receipt of an approvable letter, an

applicant may notify FDA that it agrees

to an extension of the review period so

that it can determine whether to

respond further.

Section 314.110(b) requires after

receipt of an approvable letter, an

ANDA applicant may request an

opportunity for a hearing on the

question of whether there are grounds

for denying approval of the application.

(Section 314.110(b) is included under

the parts 10 through 16 hearing

regulations, in accordance with

§ 314.201, and is not included in the

hour burden estimates in Table 1 of this

document.)

Section 314.120(a)(3) requires that,

after receipt of a not approvable letter,

an applicant may request an

opportunity for a hearing on the

question of whether there are grounds

for denying approval of the application.

(Section 314.120(a)(3) is included under

the parts 10 through 16 hearing

regulations, in accordance with

§ 314.201, and is not included in the

hour burden estimates in Table 1 of this

document.)

Section 314.120(a)(5) requires that,

after receipt of a not approvable letter,

an applicant may notify FDA that it

agrees to an extension of the review

period so that it can determine whether

to respond further.

Section 314.122(a) states that an

ANDA or a suitability petition that

relies on a listed drug that has been

voluntarily withdrawn from sale must

be accompanied by a petition seeking a

determination whether the drug was

withdrawn for safety or effectiveness

reasons. (Section 314.122(a) is already

approved by OMB under 0910–0183 and

is not included in the hour burden

estimates in Table 1 of this document.)
29232 Federal Register / Vol. 63, No. 102 /Thursday, May 28, 1998 / Notices

Section 314.122(d) sets forth

requirements for relisting petitions for

unlisted discontinued products.

(Section 314.122(d) is already approved

by OMB under 0910–0183 and is not

included in the hour burden estimates

in Table 1 of this document).

Section 314.126(c) sets forth

requirements for a petition to waive

criteria for adequate and well-controlled

studies. (Section 314.126(c) is already

approved by OMB under 0910–0183 and

is not included in the hour burden

estimates in Table 1 of this document.)

Section 314.151(a) and (b) sets forth

requirements for the withdrawal of and

approval of an ANDA and the

applicant’s opportunity for a hearing

and submission of comments. (Section

314.151(a) and (b) is included under the

parts 10 through 16 hearing regulations,

in accordance with § 314.201, and it is

not included in the hour burden

estimates in Table 1 of this document.)

Section 314.151(c) sets forth the

requirements for withdrawal of approval

of an ANDA and the applicant’s

opportunity to submit written objections

and participate in a limited oral hearing.

(Section 314.151(c) is included under

the parts 10 through 16 hearing

regulations, in accordance with

§ 314.201, and is not included in the

hour burden estimates in Table 1 of this

document.)

Section 314.152(b) sets forth the

requirements for suspension of an

ANDA when the listed drug is

voluntarily withdrawn for safety and

effectiveness reasons, and the

applicant’s opportunity to present

comments and participate in a limited

oral hearing. (Section 314.152(b) is

included under the parts 10 through 16

hearing regulations, in accordance with

§ 314.201, and is not included in the

hour burden estimates in Table 1 of this

document.)

Section 314.161(b) and (e) sets forth

the requirements for submitting and

petition to determine whether a listed

drug was voluntarily withdrawn from

sale for safety or effectiveness reasons.

(Section 314.161(b) and (e) is already

approved by OMB under 0910–0183 and

is not included in the hour burden

estimates in Table 1 of this document.)

Section 314.200(c), (d), and (e)

requires that applicants or others subject

to a notice of opportunity for a hearing

who wish to participate in a hearing

must file a written notice of

participation and request for a hearing

as well as the studies, data, and so forth,

relied on. Other interested persons may

also submit comments on the notice.

This section also sets forth the content

and format requirements for the

applicants’ submission in response to

notice of opportunity for hearing.

(Section 314.200(c), (d), and (e) is

included under the parts 10 through 16

hearing regulations, in accordance with

§ 314.201, and is not included in the

hour burden estimates in Table 1 of this

document.)

Section 314.200(f) requires that

participants in a hearing may make a

motion to the presiding officer for the

inclusion of certain issues in the

hearing. (Section 314.200(f) is included

under the parts 10 through 16 hearing

regulations, in accordance with

§ 314.201, and is not included in the

hour burden estimates in Table 1 of this

document.)

Section 314.200(g) requires that a

person may respond to a proposed order

from FDA denying a request for a

hearing by providing sufficient data,

information, and analysis to

demonstrate that there is a genuine and

substantial issue of fact which justifies

a hearing. (Section 314.200(g) is

included under the parts 10 through 16

hearing regulations, in accordance with

§ 314.201, and is not included in the

hour burden estimates in Table 1 of this

document.)

Section 314.420 states that an

applicant may submit to FDA a drug

master file in support of an application,

in accordance with certain content and

format requirements.

Section 314.430 states that data and

information in an application are

disclosable under certain conditions,

unless the applicant shows that

extraordinary circumstances exist.

(Section 314.430 is included under the

parts 10 through 16 hearing regulations,

in accordance with § 314.201, and is not

included in the hour burden estimates

in Table 1 of this document.)

Section 314.530(c) and (e) requires

that, if FDA withdraws approval of a

drug approved under the accelerated

approval procedures, the applicant has

the opportunity to request a hearing and

submit data and information. (Section

314.530(c) and (e) is included under the

parts 10 through 16 hearing regulations,

in accordance with § 314.201, and is not

included in the hour burden estimates

in Table 1 of this document.)

Section 314.530(f) requires that an

applicant must first submit a petition for

stay of action before requesting an order

from a court for a stay of action pending

review. (Section 314.530(f) is already

approved by OMB under 0910–0194 and

is not included in the hour burden

estimates in Table 1 of this document.)

Section 314.550 requires that

applicants must submit all promotional

materials to FDA for consideration

during the preapproval review period.

(Section 314.550 is already approved by

OMB in ‘‘Transmittal of Advertisements

and Promotional Labeling for Drugs and

Biologics for Human Use,’’ which

published in the Federal Register (62

FR 55408), and is not included in the

hour burden estimates in Table 1 of this

document.)

Based on information provided by the

pharmaceutical industry for the number

of ‘‘hours per response,’’ and based on

submissions collected and data

tabulated by FDA for the ‘‘number of

respondents,’’ the ‘‘number of responses

per respondent,’’ and the number of

‘‘total annual responses,’’ FDA estimates

the burden of this collection of

information as follows:

TABLE 1.—Estimated Annual Reporting Burden1

21 CFR Section/Form No. of

Respondents

No. of

Responses per

Respondents

Total Annual

Responses

Hours per

Response Total Hours

314.50(b), (c), (d), (e), (f), and (k) 83 1.49 124 1,600 198,400

314.54 4 1.25 5 300 1,500

314.60 144 16.89 2,432 80 194,560

314.65 18 1.28 23 2 46

314.70 and 314.71 418 5.33 2,229 300 668,700

314.72 59 2.17 128 2 256

314.81(b)(1) (FDA 3331) 140 5 700 48 33,600

314.81(b)(2) (FDA 2252) 269 9.06 2,438 40 97,520

314.94(a) and (d) 117 3.96 464 480 222,720

314.96 315 12.43 3,915 80 313,200

314.97 152 19.74 3,000 80 240,000
Federal Register / Vol. 63, No. 102 /Thursday, May 28, 1998 / Notices 29233

TABLE 1.—Estimated Annual Reporting Burden1—Continued

21 CFR Section/Form No. of

Respondents

No. of

Responses per

Respondents

Total Annual

Responses

Hours per

Response Total Hours

314.98(c) (FDA 2252) 265 17.17 4,551 40 182,040

314.99(a) 46 13.04 600 2 1,200

314.110(a)(5) 55 1.13 62 8 496

314.120(a)(5) 26 1.12 29 8 232

314.420 450 1.11 500 8 4,000

Total Burden Hours 2,158,470

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

Dated: May 20, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–14050 Filed 5–27–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0273]

Texas Vitamin Co., RSR Laboratories

Inc.; Proposal to Withdraw Approval of

New Animal Drug Applications;

Opportunity for Hearing

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is providing an

opportunity for hearing on a proposal to

withdraw approval of new animal drug

application (NADA) 117–688 held by

Texas Vitamin Co. and NADA 140–850

held by RSR Laboratories Inc., because

the applicants have failed to submit

required periodic reports. FDA has been

unable to locate the firms and to contact

them at their previous business

addresses.

DATES: Requests for hearing with data,

analysis, and information relied upon to

justify a request for hearing are due by

June 29, 1998.

ADDRESSES: Requests for hearing filed in

response to this notice should be

identified with Docket No. 98N–0273

and sent to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Glenn A. Peterson, Center for

Veterinary Medicine (HFV–212),

Food and Drug Administration,

7500 Standish Pl., Rockville, MD

20855, 301–827–0224; or

Mukund R. Parkhie, Center for

Veterinary Medicine (HFV–216),

Food and Drug Administration,

7500 Standish Pl., Rockville, MD

20855, 301–827–6642.

SUPPLEMENTARY INFORMATION: An

applicant is required to report

periodically to the Center for Veterinary

Medicine (CVM) concerning each

applicant’s approved NADA as provided

in § 510.300 (21 CFR 510.300). Texas

Vitamin Co., P.O. Box 18417, 10695

Aledo St., Dallas, TX 57218 (last known

address), is sponsor of NADA 117–688.

RSR Laboratories Inc., 501 Fifth St.,

Bristol, TN 37620 (last known address),

is sponsor of NADA 140–850. The

sponsors have not submitted the

required periodic reports for their

NADA’s and have not responded to

CVM requests for submission of those

reports. Letters to the firms have been

returned indicating the firms are no

longer at the above-listed addresses.

Therefore, notice is given to Texas

Vitamin Co. and RSR Laboratories Inc.,

and to all other interested persons who

may be adversely affected, that the

Director, CVM, proposes to issue an

order under section 512(e) of the

Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 360b(e))

withdrawing approval of NADA’s 117–

688 and 140–850 and all amendments

and supplements thereto on the ground

that the applicants have failed to submit

the reports required under § 510.300.

Upon withdrawal of the NADA’s, the

applicable parts of the regulations in 21

CFR 510.600(c)(1) and (c)(2) and

520.580(b)(1) will be revoked.

In accordance with the provisions of

section 512 of the act and regulations

issued under it (parts 510 and 514 (21

CFR parts 510 and 514)), and under

authority delegated to the Director, CVM

(§ 5.84 (21 CFR 5.84)), CVM hereby

provides the applicants an opportunity

for hearing to show why approval of the

NADA’s and all amendments and

supplements thereto should not be

withdrawn (and the corresponding

regulations revoked) and an opportunity

to raise, for administrative

determination, all issues relating to the

legal status of the application and drug

products approved thereunder. Any

hearing would be subject to the

provisions of 21 CFR part 12.

An applicant who decides to seek a

hearing shall file on or before June 29,

1998, a written notice of appearance,

request for hearing, and data,

information, and analyses relied on to

justify a hearing as specified in

§ 514.200.

Procedures and requirements

governing this notice of opportunity for

hearing, notice of appearance and

request for hearing, submission of

information and analysis to justify a

hearing, other comments, and a grant or

denial of a hearing, are contained in

§ 514.200.

The failure of an applicant to file a

timely, written notice of appearance and

request for hearing as required by

§ 514.200 constitutes an election by the

applicant not to make use of the

opportunity for hearing concerning the

proposed action and constitutes a

waiver of any contentions about the

legal status of the product. In such case,

the Director, CVM, under the authority

delegated to him in § 5.84(a)(2), will,

without further notice, enter a final

order withdrawing approval of the

application. Thereafter, the product may

not be legally marketed, and FDA may

begin appropriate regulatory action to

remove it from the market. Any new

animal drug product that is not the

subject of an approved application is

subject to regulatory action at any time.

A request for hearing may not rest

upon mere allegations or denials, but

must set forth specific facts showing

that there is a genuine and substantial

issue of fact that justifies a hearing.

Reports submitted to remedy the

deficiencies must be complete in all

respects as required by § 510.300. If the

reports submitted are not complete or

there is no genuine and substantial issue

of fact that precludes the withdrawal of

approval, or the request for hearing is

not made in the required format or with

the required analysis, the Commissioner

of Food and Drugs will enter summary

judgment against the person who