[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                                  
----------------------------------------------------------------------------------------------------------------
                                                         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)                                                                                                        

[[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