Agency Information Collection Activities; Submission for OMB Review; Comment Request

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N-0456]

Agency Information Collection Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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

April 24, 1998.

ADDRESSES: Submit written comments on the collection of information to

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.

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: 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.

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 the Department 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

[[Page 14469]]

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:

(1) 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);

(2) Form FDA-2633--``Medical Responsibility Statement for Use of

Narcotic Drugs in a Treatment Program''. Each licensed physician

authorized to administer or 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;

(3) 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; and

(4) 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

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Annual

Form 21 CFR Section No. of Frequency per Total Annual Time per Total Hours

Respondents Response Responses Response

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Form FDA-2632, 291.505(b)(1)(i 55 1 55 105 min 96.25

Application for i), (b)(2)(i),

Approval for Use (b)(2)(vi),

of Narcotic Drugs (b)(3)(i),

in a Narcotic (c)(3),

Addiction (c)(4),

Treatment Program (d)(2)(i), and

(New Programs) (d)(4)(i)(D)

Form FDA-2632, 291.505(b)(1)(i 35 1 35 70 min 40.83

Application for i), (c)(4)

Approval for Use

of Narcotic Drugs

in a Narcotic

Addiction

Treatment Program

(Relocation)

Form FDA-2632, 291.505(c)(2)(i 60 1 60 20 min 20

Application for i),(c)(4)

Approval for Use

of Narcotic Drugs

in a Narcotic

Addiction

Treatment Program

(Sponsor Change)

Form FDA-2632, 291.505(b)(2)(i 75 1 75 15 min 18.75

Application for v), (c)(4)

Approval for Use

of Narcotic Drugs

in a Narcotic

Addiction

Treatment Program

(Levo-Alpha-

Acetyl-Methadol

(LAAM) Use)

Form FDA-2633, 291.505(c)(4) 275 1 275 15 min 68.75

Medical

Responsibility

Statement for Use

of Narcotic Drugs

in a Treatment

Program

Form FDA-2636, 291.505(f)(2) 20 1 20 10 min 3.33

Hospital Request

for Methadone

Detoxification

Treatment (New

Applicant)

Form FDA-2636, 291.505(f)(2) 5 1 5 10 min 0.83

Hospital Request

for Methadone

Detoxification

Treatment

(Administrator

Change)

[[Page 14470]]

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

deletion of )

facility in which

medication is

administered

Requests to change 291.505(d)(2)(i 25 1 25 40 min 16.66

testing )

laboratory

Reports of 291.505(d)(4)(i 32 1 32 15 min 8

addition, )(D)

modification, or

deletion of any

program services

Requests to allow 291.505(d)(6)(v 600 1 600 15 min 150

patients to take )(D)

home daily doses

greater than 100

milligrams

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

exemptions from

specific program

standards

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

approval of a )

hospital as a

temporary

treatment program

Requests for 291.505(j)(1) 5 1 5 30 min 2.5

alternative

methods of

distribution

TOTALS 2,035 3,335 1,487.9

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

information.

Dated: March 18, 1998.

William K. Hubbard,

Associate Commissioner for Policy Coordination.

[FR Doc. 98-7665 Filed 3-24-98; 8:45 am]

BILLING CODE 4160-01-F