Agency Information Collection Activities: Proposed Collection; Comment Request; Medical Devices; Humanitarian Use Devices

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N-2097]

Agency Information Collection Activities: Proposed Collection;

Comment Request; Medical Devices; Humanitarian Use Devices

AGENCY: Food and Drug Administration, HHS.

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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 information collection

and to allow 60 days for public comment in response to the notice. This

notice solicits comments on information collection requirements for

Humanitarian Use Devices, 21 CFR part 814 subpart H.

DATES: Submit written comments on the collection of information by

September 17, 1999.

ADDRESSES: 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, rm. 16B-26; 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. A

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; Humanitarian Use Devices--21 CFR Part 814--Subpart

H (OMB No. 0910-0332--Extension)

This collection implements the humanitarian use device (HUD)

provision under section 520(m) of the Federal Food, Drug, and Cosmetic

Act (the act) (21 U.S.C. 360j(m)) and 21 CFR part 814 subpart H. Under

section 520(m) of the act, FDA is authorized to exempt an HUD from the

effectiveness requirements of sections 514 and 515 of the act (21

U.S.C. 360d and 360e) provided that the device: (1) Is used to treat or

diagnosis a disease or condition that affects fewer than 4,000

individuals in the United States; (2) would not be available to a

person with such a disease or condition unless the exemption is

granted, and there is no comparable device, other than another HUD

approved under this exemption, available to treat or diagnosis the

disease or condition; and (3) the device will not expose patients to an

unreasonable or significant risk of illness or injury, and the probable

benefit to health from using the device outweighs the risk of injury or

illness from its use, taking into account the probable risks and

benefits of currently available devices or alternative forms of

treatment.

The information collection herein will allow FDA to determine

whether to: (1) Grant HUD designation of a medical device, (2) exempt a

HUD from the effectiveness requirements in sections 514 and 515 of the

act provided that the device meets requirements set forth in section

520(m) of the act, and (3) grant marketing approval(s) for the HUD.

Failure to collect this information would prevent FDA from making these

determinations. Also, this information enables FDA to determine whether

the holder of a humanitarian device exemption (HDE) is in compliance

with the HDE requirements.

Description of Respondents: Businesses or others for-profit.

FDA estimates the burden of this collection of information as

follows:

Table 1.--Estimated Annual Reporting Burden for Humanitarian Device Exemption Sponsors\1\

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Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Respondents Response Responses Response

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814.102 20 1 20 40 800

814.104(b) and 814.104(c) 15 1 15 320 4,800

814.106 15 4 60 50 3,000

814.108 12 1 12 80 960

814.116(d)(3) 1 1 1 1 1

814.124(a) 5 1 5 1 5

814.124(b) 1 1 1 2 2

814.126(b)(1) 15 1 15 120 1,800

[[Page 38674]]

Total 11,368

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\1\ There are no capital costs or operating and maintenance costs associated with this collection of

information.

Table 2.--Estimated Annual Recordkeeping Burden for Humanitarian Device Exemption Sponsors\1\

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Annual

21 CFR Section No. of Frequency per Total Annual Hours per Total Hours

Recordkeepers Recordkeeping Records Recordkeeper

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814.126(b)(2) 15 1 15 2 30

Total 30

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\1\ There are no capital costs or operating and maintenance costs associated with this collection of

information.

A. Explanation of Report Burden Estimate:

Generally, the information requested from respondents represents an

accounting of information already in the possession of the applicant.

In the original publication in the Federal Register of the final

rule for HUD's on June 26, 1996, FDA based its estimates on comments

received to the proposed rule, industry contact, and internal FDA

benchmark factors (such as the number of PMA's processed). The numbers

generated in the current estimate as shown in Tables 1 and 2 of this

document and described in the following paragraphs, are based upon

those prior estimates, and they have only been modified if actual

numbers over the past 3 years have indicated a significantly different

trend.

The first HUD rule became effective in fiscal year 1997, and FDA

has only a few years of actual data to compare to original estimated

numbers. Although actual numbers are less than the estimated numbers

for this information collection, FDA believes that as manufacturers

become more familiar with the program, FDA will experience a larger

number of submissions under the provisions discussed as follows:

Sec. 814.102--It is estimated that 20 sponsors per year will submit

a request for HUD designation. It is estimated to require 40 staff

hours to complete each HUD designation request.

Sec. 814.104--FDA estimates 15 sponsors per year will submit an HDE

application after receiving HUD designation. FDA estimates that it will

require an average of 320 staff hours to complete each HDE application.

Sec. 814.110(a) requires that a new indication for use of a HUD

approved under this part be submitted as a new HDE application

complying with Sec. 814.104. All burden under this section is included

under the estimate for Sec. 814.104.

Sec. 814.106--It is estimated that 4 times per year FDA will

request or the sponsor will submit additional information or resubmit

an HDE or HDE supplement for approximately 15 of the submitted HDE

applications. FDA estimates that it will require the respondents to

take an average of 50 staff hours to complete each amendment or

resubmitted application. If the FDA refuses to file the HDE

application, requests for an informal conference (under

Sec. 814.112(b)) will be processed as an HDE amendment. Responses to

approvable and not approvable letters (Sec. 814.116(b), (c), and (d))

will be processed as HDE amendments. A request for an opportunity for

an informal hearing, prior to FDA issuing an order withdrawing

approval, under Sec. 814.118(d), will be processed as an HDE amendment.

Because FDA only tracks amendments, and not the reasons for the

amendment, the burden estimates for the sections listed in the Tables 1

and 2 of this document are included in the burden estimate for

Sec. 814.106.

Sec. 814.108--FDA anticipates that it will receive approximately 12

supplements for the submitted HDE applications. It is estimated that it

will take approximately 80 staff hours to complete each supplemental

application.

Sec. 814.116(d)(3)--FDA believes that it will receive approximately

1 request to withdraw an HDE application per year, based on withdrawals

submitted in FY 1997 and FY 1998. FDA estimates it will take no longer

than 1 staff hour to complete each written withdrawal notice.

Sec. 814.124(a)--FDA anticipates that 5 physicians will use HUD's

in emergency situations before obtaining institute and review board

(IRB) approval. FDA estimates that notification under this section will

take an average of 1 hour per response.

Sec. 814.124(b)--FDA anticipates that one holder of an approved HDE

will notify FDA of IRB withdrawal of approval. FDA estimates that it

will take an average of 2 staff hours to notify FDA of IRB withdrawal.

Sec. 814.126(b)(1)--Following FDAMA, Sec. 814.126 was amended to

incorporate section 520(m)(5) of the act (21 U.S.C. 360j), which

provides FDA the authority to require an HDE applicant to demonstrate

continued compliance with the HDE requirements, if the agency believes

that such a demonstration is necessary to protect the public health or

has reason to believe that the criteria for the HDE exemption are no

longer met. FDA amended this section to delete the requirement of an

annual report and to include instead a periodic reporting requirement

that will be established by the approval order for the HDE. This

provision permits the agency to obtain sufficient information for it to

determine whether there is reason to question the continued exemption

of the device from the act's effectiveness requirements.

FDA anticipates that because of this amendment, the 15 HDE holders

will remain active and therefore, estimates that 15 periodic reports

will be received. FDA also estimates that it will take an average of

120 staff hours to complete a periodic report as a result of this

amendment.

B. Explanation of Recordkeeping Burden Estimate:

Sec. 814.126(b)(2)--FDA anticipates that 15 HDE holders per year

will maintain records of certain required information. It is estimated

that it will take an average of 2 staff hours to maintain this

information.

[[Page 38675]]

Dated: July 12, 1999.

Margaret M. Dotzel,

Acting Associate Commissioner for Policy Coordination.

[FR Doc. 99-18234 Filed 7-16-99; 8:45 am]

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