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 Department of Health and Human Services Food and Drug Administration [Docket No. 00N-1604]
 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.
 DATES: Submit written comments on the collection of information by March 12, 2001.
 ADDRESSES: Submit written comments on the collection of information to the Office of Information and Regulatory Affairs, OMB, New Executive Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: Wendy Taylor, Desk Officer for FDA.
 FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.


SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. OTC Test Sample Collection Systems for Drugs of Abuse Testing—21 CFR Part 809 (OMB Control Number 0910-0368)—Extension FDA  has  reclassified over-the-counter (OTC)  test  sample  collection  systems  for  drugs  of  abuse  testing  from  class  III  (premarket  approval)  into  class  I  (general  controls)  subject  to  restrictions  established  in  accordance  with  section  520(e)  of  the  Federal  Food,  Drug,  and  Cosmetic  Act  (21  U.S.C.  360j)(e). The  labeling  requirements  for  certain  in  vitro  diagnostic  products  require  that  manufacturers  of  OTC  test  sample  collection  systems  for  drugs  of  abuse  testing  provide  certain  information  to  consumers  for  the  proper  use  of  the  test  sample  collection  system  and  for  interpreting  the  results.    The  purpose  of  this  regulation  is  to  ensure  that  lay  persons  collecting  samples  for  testing  have  adequate  instructions  for  sample  collection  and  handling  and  for  receiving  and  understanding  the  test  results  reported  by  laboratories  performing  the  analyses. The  most  likely  respondents  to  this information  collection  will  be  manufacturers  of  over-the-counter  drugs  of  abuse  test  kits. In  the 
                    **Federal Register**
                     of  November  16,  2000  (65  FR  69314),  the  agency  requested  comments  on  the  proposed collection  of  information.   No  comments  were  received. FDA  estimates  the  burden  of  this  collection  of  information  as  follows: **Table**
                        1.—
                        **Estimated Annual Reporting Burden**1
21 CFR Section
No. of respondents
Annual frequency per response
Total annual 
                             responses
Hours per response
Total Hours809.10
20
1
20
100
2,0001
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 Based  upon  submissions  to  the  agency  (premarket  notifications,  premarket  approval  applications,  registration  and  listing),  FDA  estimates  that  there  will  be  about  20  manufacturers  of  these  devices. FDA  estimates,  based  upon  discussions  with  manufacturers  of  similar  devices  required  to  comply  with  21  CFR  809.10,  that  it  will  take  approximately  40  hours  to  gather  the  information  required  by  the  rule,  40  hours  to  design  and  prepare  the  labeling,  and  an  additional  20  hours  per  year  to  review  and  revise  the  labeling  as  necessary. Dated: February 2, 2001. William K. Hubbard, Senior Associate Commissioner for Policy, Planning, and Legislation.


[FR Doc. 01-3322 Filed 2-7-01; 8:45 am] BILLING CODE 4160-01-S