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 Department of Health and Human Services Food and Drug Administration [Docket No.  01N-0222]
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 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  extension  of  an  existing  collection of information,  and  to  allow  60  days  for  public  comment  in  response  to  the  notice.   This  notice  solicits  comments  on  information  collection  requirements  for  medical  devices;  third-party  review  under  the  Food  and  Drug  Administration  Modernization  Act  of  1997  (FDAMA).
 DATES: Submit  written  or  electronic  comments  on  the  collection  of  information  by  July 30, 2001.
 ADDRESSES: Submit  electronic  comments  on  the  collection  of  information  to  http://www.accessdata.fda.gov/​scripts/​oc/​dockets/​edockethome.cfm.   Submit  written  comments  on  the  collection  of  information  to  the  Dockets  Management  Branch  (HFA-305),  Food  and  Drug  Administration,  5630  Fishers  Lane,  rm.  1061,  Rockville,  MD   20852.   All  comments  should  be  identified  with  the  docket  number  found  in  brackets  in  the  heading  of  this  document.
 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: 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  extension  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  set  forth  in  this  document. 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. Medical  Devices;  Third-Party  Review  Under  FDAMA  (OMB  Control  No.  0910-0375)—Extension Section  210  of  FDAMA  established  a  new  section  523  of  the  Federal  Food,  Drug,  and  Cosmetic  Act  (the  act),  directing  FDA  to  accredit  persons  in  the  private  sector  to  review  certain  premarket  applications  and  notifications.   As  with  the  third-party  pilot  program  conducted  previously  by  FDA,  participation  in  this  third-party  review  program  by  accredited  persons  is  entirely  voluntary.   A  third  party  wishing  to  participate  will  submit  a  request  for  accreditation.   Accredited  third-party  reviewers  have  the  ability  to  review  a  manufacturer's  510(k) 
                    ( print page 29143)
                     submission  for  selected  devices.   After  reviewing  a  submission,  the  reviewer  will  forward  a  copy  of  the  510(k)  submission,  along  with  the  reviewer's  documented  review  and  recommendation,  to  FDA.   Third-party  reviews  should  maintain  records  of  their  510(k)  reviews  and  a  copy  of  the  510(k)  for  a  reasonable  period  of  time.  This  information  collection  will  allow  FDA  to  continue  to  implement  the  accredited person  review  program  established  by  FDAMA  and  improve  the  efficiency  of  510(k)  review  for  low  to  moderate  risk  devices. Respondents  to  this  information  collection  are  businesses  or  other  for-profit  organizations. FDA  estimates  the  burden  of  this  collection  of  information  as  follows: **Table**
                         1.—
                        **Estimated Annual Reporting Burden**
                         1
Item
No. of ­Respondents
Annual ­Frequency ­per ­Response
Total ­Annual ­Responses
Hours per ­Response
Total HoursRequests  for  ­accreditation
40
1
40
24
960510(k)  ­reviews  ­conducted  by  accredited  third parties
35
4
140
40
5,600Total




6,5601
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 **Table**
                         2.—
                        **Estimated Annual Recordkeeping Burden**1
Item
No. of ­Recordkeepers
Annual ­Frequency ­per ­Recordkeeper
Total Annual Records
Hours per ­Recordkeeper
Total Hours510(k)  ­reviews
35
4
140
10
1,400Total




1,4001
                         There are no capital costs or operating and maintenance costs associated with this collection of information.
 The burdens are explained as follows: 1.    Reporting a. 
                    *Requests  for  accreditation*.   Under  the  agency's  third-party  review  pilot  program,  the  agency  received  37  applications  for  recognition  as  third-party  reviewers,  of  which  the  agency  recognized  7.   Under  this  expanded  program,  the  agency  anticipates  that  it  will  not  see  a  significant  increase  in  the  number  of  applicants.   Therefore,  the  agency  is  estimating  that  it  will  receive  40  applications.   The  agency  anticipates  that  it  will  accredit  35  of  the  applicants  to  conduct  third-party  reviews. b. 
                    *510(k)  reviews  conducted  by  accredited  third parties*.   In  the  18  months  under  the  third-party  review  pilot  program,  FDA  received  only  22  510(k)s  that  requested  and  were  eligible  for  review  by  third  parties.   Because  the  third-party  review  program  is  not  as  limited  in  time,  and  is  expanded  in  scope,  the  agency  anticipates  that  the  number  of  510(k)s  submitted  for  third-party  review  will  remain  the  same  as  they  were  during  the  last  OMB  approval  in  1998.   The  agency  anticipates  that  it  will  receive  approximately  140  third-party  review  submissions  annually,  i.e.,  approximately  4  annual  reviews  per  each  of  the  estimated  35  accredited  reviewers. 2.   Recordkeeping Third-party  reviewers  are  required  to  keep  records  of  their  review  of  each  submission.   The  agency  anticipates  approximately  140  annual  submissions  of  510(k)s  for  third-party  review. The estimate of the times required for record preparation and maintenance is based on agency communication with industry.  Other information needed to calculate the total burden hours (i.e., adverse drug reaction, lack of effectiveness, and product defect reports) are derived from agency records and experience. Dated:  May 18, 2001. Margaret M. Dotzel, Associate Commissioner for Policy.


[FR Doc. 01-13301 Filed 5-25-01; 8:45 am] BILLING CODE 4160-01-S