[Federal Register Volume 63, Number 57 (Wednesday, March 25, 1998)]
[Notices]
[Pages 14468-14470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-7665]
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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
