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 Department of Health and Human Services Food and Drug Administration [Docket No. 2004N-0442]
 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  FDA's  recall  regulations (guidelines)   and   provides   guidance   to   manufacturers   on   recall responsibilities.
 DATES: Submit  written  or  electronic  comments on the collection of information by December 13, 2004.
 ADDRESSES: Submit electronic comments on the collection of  to  information to: 
                        *http://www.fda.gov/​dockets/​ecomments*. Submit written comments on the collection of information to the Division of Dockets Management  (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: Denver   Presley, Office   of   Management   Programs   (HFA-250),    Food   and   Drug Administration,     5600     Fishers    Lane,    Rockville,    MD    20857, 301-827-1472.


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 
                    ( print page 60631)
                    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  these  topics:   (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. FDA  Recall  Regulations—21  CFR  Part  7  (OMB  Control  Number 0910-0249) Section 701 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.  371) and  part  7  (21  CFR part 7), subpart C sets forth the recall regulations (guidelines)   and   provides   guidance   to   manufacturers   on   recall responsibilities.  The  guidelines  apply  to  all  FDA-regulated  products (i.e.,  food, including animal feed; drugs, including animal drugs; medical devices,  including in vitro diagnostic products; cosmetics; and biological products  intended   for   human   use).   These  responsibilities  include development  of  a  recall strategy that  requires  time  by  the  firm  to determine  the  actions   or  procedures  required  to  manage  the  recall (§ 7.42); providing  FDA  with  complete  details  of the recall including  reason(s)  for  the  removal  or  correction,  risk  evaluation, quantity produced, distribution information, firm's recall strategy, a copy of any recall communication(s), and a contact official (§ 7.46); notifying  direct  accounts  of  the  recall,  providing guidance regarding further  distribution,  giving  instructions as to  what  to  do  with  the product, providing recipients with  a  ready  means  of  reporting  to  the recalling  firm  (§ 7.49); submitting periodic status reports so that FDA may assess  the progress of the recall.  Status report information may be determined by,  among  other  things  evaluation return reply cards, effectiveness checks and product returns (§ 7.53); and providing the opportunity for a firm to request in writing  that  FDA  terminate  the recall (§ 7.55). A  search  of  the FDA database was performed to determine the number of recalls that took place  during  fiscal year 2003.  The resulting number of recalls from this database search (2,375) is used in estimating the current annual reporting burden for this report.   FDA  estimates  the total annual industry  burden  to collect and provide the above information  to  201,875 burden hours. The following is  a  summary  of  the  estimated annual burden hours for recalling firms (manufacturers, processors,  and  distributors)  to  comply with the voluntary reporting requirements of FDA's recall regulations. Recognizing  that  there  may  be  a  vast difference in the information collection  and  reporting  time involved in  different  recalls  of  FDA's regulated products, FDA estimates  on  average the burden of collection for recall information to be as follows: **Table  1.—Estimated Annual Reporting Burden1**
21 CFR Section
No. of Respondents
Annual Frequency per Response
Total Annual Responses
Hours per Response
Total HoursRecall  Strategy (§ 7.42)
2,375
1
2,375
15
35,625Firm  Initiated  Recall  &  Public  Warnings Recall Communications (§§ 7.46 and 7.49)
2,375
1
2,375
20
47,500Recall  Status  Reports  and  Followup  (§ 7.53)
2,375
4
9,500
10
95,000Termination    of    a    Recall  (§ 7.55(b))
2,375
1
2,375
10
23,750Total




201,8751
                        There are no capital  costs  or  operating and maintenance  costs associated with this collection of information.
 The annual reporting burdens are explained as follows: *Recall Strategy* Requests  firms  to  develop a recall strategy including  provision  for  public  warnings and effectiveness  checks.   Under  this  portion  of  the  collection  of  information,  the  agency  estimates  it will receive 2,375  responses annually.  *Firm Initiated Recall and Recall Communications* Requests firms that voluntarily remove or correct voluntarily  foods and  drugs  (human  or  animal), cosmetics, medical devices, and biologicals  to  immediately notify immediately  the appropriate FDA district office of such  actions.  The firm is to provide  complete  details  of  the recall reason,  risk evaluation, quantity produced, distribution information, firms' recall  strategy, and a contact official as well as requires firms  to notify their  direct accounts of the recall and to provide recipients with  a ready means  of reporting to the recalling firm.  Under these portions of the collection  of  information,  the  agency  estimates  it  will  receive 2,375 responses  annually for each. *Recall Status Reports* Requests that recalling firms provide periodic status reports so FDA can  ascertain the progress of the recall.  This collection  of information will  generate approximately 9,500 responses annually. *Termination of a Recall* Provides the firm an opportunity to request in writing  that FDA end the  recall. The agency estimates it will receive 2,375 responses annually. Dated: October 4, 2004. Jeffrey Shuren, Assistant Commissioner for Policy.


[FR Doc. 04-22763 Filed 10-8-04; 8:45 am] BILLING CODE 4160-01-S