[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 Burden<SUP>1                                  
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                                                         Annual                                                 
       Form          21 CFR Section      No. of       Frequency per   Total Annual     Time per     Total Hours 
                                       Respondents      Response        Responses      Response                 
----------------------------------------------------------------------------------------------------------------
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