Federal Register / Vol. 62, No. 227 / Tuesday, November 25, 1997 / Notices 62773

Dated: November 19, 1997.

Bob Sargis,

Acting Reports Clearance Officer.

[FR Doc. 97–30919 Filed 11–24–97; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0456]

Agency Information Collection

Activities: Proposed Collection

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

reporting and recordkeeping

requirements relating to the use of

narcotic drugs in treating drug

addiction.

DATES: Submit written comments on the

collection of information by January 26,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

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:

Karen 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 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.

Conditions for the Use of Narcotic

Drugs for Treatment of Narcotic

Addiction Reporting and

Recordkeeping Requirements (21 CFR

291.505) (OMB Control Number 0910–

0140—Reinstatement)

Section 303(g) of the Controlled

Substances Act (21 U.S.C. 823(g))

provides for a separate controlled

substances registration for practitioners

who dispense narcotic drugs to

individuals for maintenance treatment

or detoxification treatment. This

separate registration is conditioned on

the Secretary of Health and Human

Services (the Secretary) determining

that the applicant is a practitioner who

is qualified (under standards established

by the Secretary) to engage in the

treatment with respect to which

registration is sought. Section 303(g)

requires that the Secretary (and, by

delegation, FDA and the National

Institute of Drug Abuse): (1) Establish

standards for practitioners who

dispense narcotic drugs to persons for

maintenance and/or detoxification

treatment; (2) determine whether

practitioners who wish to conduct such

treatment are qualified under the

standards; and (3) determine whether

such practitioners will comply with the

standards regarding the quantities of

narcotic drugs that may be provided for

unsupervised use by persons in such

treatment.

Regulations found at 21 CFR 291.505

were issued under this authority. These

regulations establish reporting

requirements that include an

application for approval of use of

narcotic drugs in a narcotic addiction

treatment program that must be

submitted to, and approved by, FDA

before the treatment program (which

may be an individual or an

organization) may receive shipments of

narcotic drugs. Additional submissions

are required when significant changes

are implemented by treatment programs;

for some kinds of changes, the

regulations require FDA preapproval of

the change before it is implemented.

Additional submissions and FDA

preapproval are also required if a

treatment program seeks an exemption

from certain requirements. The

regulations contain no periodic

reporting requirements.

The regulations governing the use of

narcotic drugs for treatment of addiction

also contain recordkeeping

requirements that codify usual and

customary practices within the medical

and rehabilitative communities. Because

the records required by the regulations

would be kept even without a regulatory

requirement, the time and financial

resources necessary to comply with the

recordkeeping requirements have not

been included in the burden estimate

below (see 5 CFR 1320.3(b)(2)).

FDA is requesting approval of the

following FDA forms:

Form FDA–2632—‘‘Application for

Approval for Use of Narcotic Drugs

in a Narcotic Addiction Treatment

Program’’. Organizations or

individuals who wish to receive

shipments of narcotic drugs for the

treatment of narcotic addiction are

required to submit this form in

duplicate to FDA and to the

appropriate State regulatory

authority. All information and

attachments to the application are

required by the regulation. The

application must include a list of

personnel active in the program,

such as physicians, nurses, and

counselors; the names of hospitals,

institutions, and analytical

laboratories; and all other facilities

used to provide necessary services

required by the regulations. Form

FDA–2632 is also used to report to

FDA that a program will relocate,

change the sponsor, or dispense

Levo-Alpha-Acetyl-Methadol

(LAAM).

Form FDA–2633—‘‘Medical

Responsibility Statement for Use of

Narcotic Drugs in a Treatment

Program’’. Each licensed physician

authorized to administer or
62774 Federal Register / Vol. 62, No. 227 / Tuesday, November 25, 1997 / Notices

dispense narcotic drugs for the

treatment of narcotic addiction

must complete this form and submit

it to FDA and to the appropriate

State regulatory authority.

Form FDA–2635—‘‘Consent to

Treatment with an Approved

Narcotic Drug’’. This form is to be

completed by the practitioner and

signed by the patient when the

practitioner explains the treatment

program to each new patient. The

completed form becomes part of the

patient’s records and is not

transmitted to FDA. Having a

patient execute an informed

consent form before undertaking a

course of medical therapy, such as

maintenance or detoxification, is

usual and customary medical

practice.

Form FDA–2636—‘‘Hospital Request

for Methadone Detoxification

Treatment’’. Before a hospital may

receive shipments of methadone for

detoxification treatment, a

responsible official of the hospital

must submit this form to FDA and

to the appropriate State regulatory

authority, and must have received a

notice of approval from FDA. Form

FDA–2636 is also used to inform

FDA of changes in responsible

hospital administrators.

Respondents to this information

collection are sponsors and physicians,

for treatment programs, and hospital

officials, for hospital detoxification

programs.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Form 21 CFR Section No. of Respondents

Annual Frequency per Response

Total Annual

Responses

Time per

Response Total Hours

Form FDA–2632, Application

for Approval for Use of Narcotic Drugs in a Narcotic

Addiction Treatment Program (New Programs)

291.505(b)(1)(ii),

(b)(2)(i), (b)(2)(vi),

(b)(3)(i), (c)(3), (c)(4),

(d)(2)(i), and

(d)(4)(i)(D)

55 1 55 105 min 96.25

Form FDA–2632, Application

for Approval for Use of Narcotic Drugs in a Narcotic

Addiction Treatment Program (Relocation)

291.505(b)(1)(ii), (c)(4) 35 1 35 70 min 40.83

Form FDA–2632, Application

for Approval for Use of Narcotic Drugs in a Narcotic

Addiction Treatment Program (Sponsor Change)

291.505(c)(2)(ii),(c)(4) 60 1 60 20 min 20

Form FDA–2632, Application

for Approval for Use of Narcotic Drugs in a Narcotic

Addiction Treatment Program (Levo-Alpha-AcetylMethadol(LAAM)Use)

291.505(b)(2)(iv), (c)(4) 75 1 75 15 min 18.75

Form FDA–2633, Medical Responsibility Statement for

Use of Narcotic Drugs in a

Treatment Program

291.505(c)(4) 275 1 275 15 min 68.75

Form FDA–2636, Hospital Request for Methadone Detoxification Treatment (New

Applicant)

291.505(f)(2) 20 1 20 10 min 3.33

Form FDA–2636, Hospital Request for Methadone Detoxification Treatment (Administrator Change)291.505(f)(2) 5 1 5 10 min 0.83

Notifications of deletion of facility in which medication is

administered

291.505(b)(2)(i) 45 1 45 15 min 11.25

Requests to change testing

laboratory

291.505(d)(2)(i) 25 1 25 40 min 16.66

Reports of addition, modification, or deletion of any program services291.505(d)(4)(i)(D) 32 1 32 15 min 8

Requests to allow patients to

take home daily doses

greater than 100 milligrams

291.505(d)(6)(v)(D) 600 1 600 15 min 150

Requests for exemptions from

specific program standards

291.505(d)(11) 800 3 2,100 30 min 1,050

Requests for approval of a

hospital as a temporary

treatment program

291.505(f)(2)(i) 3 1 3 15 min .75

Requests for alternative methods of distribution291.505(j)(1) 5 1 5 30 min 2.5

TOTALS 2,035 3,335 1,487.9

1There are no capital costs or operating and maintenance costs associated with this collection of information.
Federal Register / Vol. 62, No. 227 / Tuesday, November 25, 1997 / Notices 62775

These estimates are based on

conversations with treatment and

detoxification programs, on the number

of responses received in past years, and

on examination of received responses.

Dated: November 18, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–30911 Filed 11–24–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0376]

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

that a proposed collection of

information has been submitted to the

Office of Management and Budget

(OMB) for emergency processing under

the Paperwork Reduction Act of 1995

(the PRA). The purpose of the proposed

collection of information, a two-part

telephone survey of tobacco retailers, is

to assess the effectiveness of an

advertising campaign aimed at

increasing retailers’ awareness of, and

motivating retailers to comply with,

new regulations that prohibit retailers

from selling cigarettes and smokeless

tobacco to persons younger than 18

years of age and require retailers to

verify, by means of photographic

identification containing the bearer’s

date of birth, the age of every purchaser

who is younger than 27 years old. The

first phase of the survey must be

completed by December 31, 1997.

DATES: Submit written comments on the

collection of information by December

5, 1997.

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, Attn: Desk

Officer for FDA. 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, rm. 16B–18, Rockville,

MD 20857, 301–827–1482.

SUPPLEMENTARY INFORMATION: 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.

Tobacco Retailer Tracking Survey

On February 28, 1997, new Federal

regulations at 21 CFR part 897 went into

effect that prohibit retailers from selling

cigarettes and smokeless tobacco to

persons younger than 18 years of age,

and require retailers to verify, by means

of photographic identification, the age

of purchasers younger than 27 years old.

FDA is planning to conduct a pilot

advertising will campaign, in one State,

aimed at raising retailers’ awareness of

the new regulations, and motivating

retailers to comply. The campaign will

target persons who sell cigarettes or

smokeless tobacco to consumers for

their personal use, including clerks and

cashiers in grocery and convenience

stores, pharmacies and drug stores, gas

stations, liquor stores, taverns and bars,

and tobacco stores. As part of the pilot,

FDA is proposing to conduct a two-part

telephone survey of tobacco retailers to

measure their awareness of, and selfreported compliance with, the new

regulations before and after exposure to

the advertising campaign in the test

State. FDA also would study levels of

awareness and self-reported compliance

among tobacco retailers in a control

State matched demographically with the

test State. Retailers in the control State

would not be exposed to the media

campaign, and FDA would not be

actively conducting compliance checks

before awareness and self-reported

levels of compliance are measured.

A random sample of 1,350 tobacco

retailers in the test State (675 for each

phase) and 300 tobacco retailers in the

control State would be selected for a

telephone interview. All interviewing

would be conducted by a single market

research firm that would employ

computer-aided telephone interviewing

technology to expedite the fieldwork

and ensure accuracy. FDA plans to use

the results of the survey in designing a

nationwide advertising campaign that

would help to reduce youth access to

cigarettes and smokeless tobacco. Under

21 U.S.C. 393(b)(2)(C), FDA is

authorized to conduct surveys and other

research relating to its responsibilities

under the Federal Food, Drug, and

Cosmetic Act.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

No. of Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

1,650 survey 1 1,650 .2 330

Total 1,650 330

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

FDA has requested emergency

processing of this proposed collection of

information under section 3507(j) of the

PRA and 5 CFR 1320.13. This

information is needed by December 31,

1997, and is essential to the agency’s

mission. The use of normal PRA

clearance procedures would be likely to

result in the prevention or disruption of

this collection of information.

Dated: November 19, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–30912 Filed 11–24–97; 8:45 am]

BILLING CODE 4160–01–F