E9-23521. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and Food and Drug ...

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

DATES:

Fax written comments on the collection of information by October 30, 2009.

ADDRESSES:

To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: [phone], or e-mailed to [e-mail]. All comments should be identified with the OMB control number 0910-NEW and title Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and FDA Staff: Humanitarian Device Exemption Regulation: Questions and Answers; Availability. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Denver Presley Jr., Office of Information Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-3793.

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.

Guidance for Humanitarian Device Exemption Holders, Institutional Review Boards, Clinical Investigators, and FDA Staff: Humanitarian Device Exemption Regulation: Questions and Answers—(OMB Control Number 0910-NEW)

Title III of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law 110-85) amended chapter V of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 351 et seq.) by inserting section 515A, Pediatric Uses of Devices (21 U.S.C. 360e-1).

This new provision requires that new applications under section 520(m) of the act (21 U.S.C. 360j(m)) include both a description of any pediatric subpopulation that suffer from: (1) A disease or condition that the device is intended to treat, diagnose, or cure and (2) the number of affected pediatric patients.

Title III of FDAAA also amended section 520(m) of the act as follows:

Section 520(m)(6)(A)(ii) of the act provides that the Secretary of Health and Human Services will assign an annual distribution number (ADN) for devices indicated for use in a pediatric population or in a pediatric subpopulation. The ADN shall be based on the following information in a humanitarian device exemption (HDE) application: (1) The number of individuals affected by the disease or condition that such device is intended to treat, diagnose, or cure and of that number; (2) the number of individuals likely to use the device and (3) the number of devices reasonably necessary to to treat such individuals.

Section 520(m)(6)(A)(iii) of the act provides that an HDE holder immediately notify the agency if the number of devices distributed during any calendar year exceeds the ADN.

Section 520(m)(6)(C) of the act provides that an HDE holder may petition to modify the ADN if additional information on the number of individuals affected by the disease or condition arises.

In the Federal Register of August 5, 2008 (73 FR 45460), FDA published a 60-day notice requesting public comment on the information collection provisions. Seven comments were received in response to the 60-day notice. Of the seven comments received, six related to the guidance and the information collection requests. We received one comment that did not address the content of the guidance nor the information collection.

There were a number of comments received that clarified the reporting requirements for HDE holders and institutional review boards (IRBs). In response to these comments, FDA responded by referring to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR 803.50 have been approved under OMB control number 0910-0437 and the collections of information in part 814 (21 CFR part 814) have been approved under OMB control number 0910-0332. FDA received comments that sought clarification regarding how an IRB distinguishes between the use of a humanitarian use device (HUD) and the study of an HUD in a clinical investigation. FDA responded by providing additional background information related to the collection of safety and effectiveness information related to clinical investigation for HDE approved indications and referring to previously approved collections of information found in FDA regulations. This collection of information is approved under OMB control number 0910-0078.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden¹

Section of the Federal Food, Drug, and Cosmetic Act	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
515A(a)(2)	5	1	5	100	500
520(m)(6)(A)(ii)	3	1	3	50	150
520(m)(6)(A)(iii)	1	1	1	100	100
520(m)(6)(C)	5	1	5	100	500
Total					1,250
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

FDA based these estimates on the number of original HDE applications that the Center for Devices and Radiological Health (CDRH) received in the period between October 1, 2004, and September 30, 2007. During that time, CDRH received 16 original HDE applications or about 5 per year.

FDA estimates that for each year, CDRH will receive five HDE applications and that three of these applications will be indicated for pediatric use. One HDE holder will notify the agency that the number of devices distributed in the year has exceeded the ADN and five HDE holders will petition to have the ADN modified due to additional information on the number of individuals affected by the disease of condition.

The draft guidance refers also to previously approved collections of information found in FDA regulations. The collections of information in 21 CFR part 803 have been approved under OMB control number 0910-0437; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 807, subpart E have been approved under OMB control number 0910-0120; the collections of information in part 814, subparts A, B, and C have been approved under OMB control number 0910-0231; the collection of information in 21 CFR parts 50 and 56 have been approved under OMB control number 0910-0130; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; the collections of information in part 814, subpart H have been approved under OMB control number 0910-0332; and the collection of information requirements in 21 CFR 10.30 have been approved under OMB control number 0910-0183.

Dated: September 23, 2009.

David Horowitz,

Assistant Commissioner for Policy.