[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] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- \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