[Federal Register Volume 62, Number 227 (Tuesday, November 25, 1997)]
[Notices]
[Pages 62773-62775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-30911]
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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.
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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
[[Page 62774]]
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
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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)
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.
[[Page 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
