[Federal Register Volume 63, Number 152 (Friday, August 7, 1998)]
[Notices]
[Pages 42404-42405]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-21088]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0515]


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 
September 8, 1998.

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: 
Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT: Margaret R. 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 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.

Amendments to Humanitarian Use Device (HUD) Requirements

    Section 520(m) of the Federal Food, Drug, and Cosmetic Act (the 
act) (21 U.S.C. 360j(f)) was created as an incentive for the 
development of HUD's for use in the treatment or diagnosis of diseases 
or conditions affecting fewer than 4,000 individuals in the United 
States. FDA is issuing this rule to amend the existing regulations 
governing HUD's, found in part 814 (21 CFR part 814), to conform to the 
amendments made by the Food and Drug Administration Modernization Act 
of 1997 (FDAMA) to section 520(m) of the act.
    In the Federal Register of April 17, 1998 (63 FR 19185), the agency 
requested comments on the proposed collection of information amending 
the regulations governing HUD's. FDA received one comment concerning 
the information collection provisions of the rule. A summary of the 
comment and FDA's response is provided as follows.
    The comment objected to the annual reporting requirement and 
suggested that FDA determine the appropriate reporting period at the 
time of product approval rather than always requiring reporting on an 
annual basis.
    FDA has modified the rule in response to this comment. Under the 
final rule of June 26, 1996 (61 FR 33232), a humanitarian device 
exemption (HDE) holder was required to obtain approval of an extension 
request every 18 months in order to continue marketing the HUD. FDAMA 
eliminated this requirement but provided that FDA may require the 
holder to demonstrate continued compliance with the HDE requirements if 
the agency believes that such demonstration is needed to protect the 
public health or has reason to believe that the criteria for the 
exemption are no longer met.
    FDA included a provision for annual reporting in the proposed rule 
because the agency believed that annual reporting would be the most 
appropriate mechanism for the agency to monitor whether there is reason 
to question the continued exemption of the device from the act's 
effectiveness requirements. Upon reconsideration, FDA has determined 
that the reporting frequency necessary to protect the public health may 
vary depending upon the device, its intended use, the affected patient 
population, and experience with the device after it is marketed. 
Therefore, Sec. 814.126(b)(1) has been modified in the final rule to 
state that the frequency of the reports will be specified in the 
approval order for the HDE. Ordinarily, FDA does not expect to require 
periodic reports to be submitted more frequently than annually. FDA 
does believe, however, that it may be appropriate to require reports on 
certain HDE's less frequently and that in many cases the frequency of 
required reports will decrease after the device has been marketed for a 
period of time.
    FDA estimates that, due to the nature of some of the devices, 
initially 15 HDE holders per year will be required to submit annual 
reports. As the agency and industry gain experience with HDE's, FDA 
believes the number of HDE holders who will be required to submit 
annual reports will decrease. FDA believes that much of the information 
will already be in the HDE holder's possession, and the agency 
estimates that the reports will take an average of 120 hours per 
response.
    The same comment also objected to the ``requirement'' that an ``HDE 
holder maintain records in perpetuity * * *'' and suggested that a more 
appropriate timeframe would be 3-calendar years after the manufacturer 
ceases distribution of the product in question.
    Section 814.126(b)(2) of the HDE regulation specifies the types of 
records that should be maintained by the HDE holder, but does not 
specify the

[[Page 42405]]

timeframe for maintaining such records. FDA agrees that a reasonable 
timeframe should be established for maintaining such records and 
intends to specify such timeframes as part of the approval order. 
Accordingly, FDA has modified the regulation to state that records 
shall be maintained in accordance with the approval order for the HDE.
    Section 814.124(a) is amended to allow physicians in emergency 
situations to administer a HUD prior to obtaining institutional review 
board (IRB) approval. In such situations, the physician is required to 
provide written notification, including the identification of the 
patient involved, the date of use, and the reason for use, to the IRB 
within 5 days after emergency use. FDA anticipates that five physicians 
will use HUD's in emergency situations before obtaining approval from 
an IRB. FDA estimates that notifications under this section will take 
an average of 1 hour per response.
    In addition to the changes required by FDAMA, FDA is amending 
Sec. 814.104(b)(5) to allow a sponsor who is charging more than $250 
per HUD to submit, in lieu of a report by an independent CPA, an 
attestation by a responsible individual of the organization, verifying 
that the amount charged does not exceed the device's cost of research, 
development, fabrication, and distribution. In addition, the amendments 
to Sec. 814.104(b)(5) waive the requirement for submission of any CPA 
report or attestation for HUD's for which an HDE applicant is charging 
$250 or less. FDA anticipates, based on past experience, that 7 of the 
anticipated 15 HDE holders per year will charge less than $250 per HUD, 
and thus be exempt from the Sec. 814.104(b)(5) requirement altogether. 
For the remaining eight HDE holders, FDA anticipates that all will 
submit attestations in lieu of CPA reports, and estimates that these 
submissions will require 2 hours to complete.
    Description of Respondents: Business or other for profit 
organizations.
    FDA estimates the burden for this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1                                  
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                    Respondents      Response        Responses       Response                   
----------------------------------------------------------------------------------------------------------------
814.104(b)(5)                           8               1               8               2              16       
814.124(a)                              5               1               5               1               5       
814.126(b)(1)                          15               1              15             120           1,800       
Total                                                                                               1,821       
----------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs or capital costs associated with this collection of            
  information.                                                                                                  


                                Table 2.--Estimated Annual Recordkeeping Burden1                                
----------------------------------------------------------------------------------------------------------------
                                                      Annual                                                    
         21 CFR Section               No. of       Frequency per   Total Annual      Hours per      Total Hours 
                                   Recordkeepers   Recordkeeping      Records      Recordkeeper                 
----------------------------------------------------------------------------------------------------------------
814.126(b)(2)                          15               1              15               2              30       
----------------------------------------------------------------------------------------------------------------
\1\ There are no operating and maintenance costs or capital costs associated with this collection of            
  information.                                                                                                  


    Dated: July 31, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-21088 Filed 8-6-98; 8:45 am]
BILLING CODE 4160-01-F