[Federal Register Volume 72, Number 102 (Tuesday, May 29, 2007)]
[Notices]
[Pages 29515-29517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-10271]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0420]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Orphan Drugs

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 June 
28, 2007.

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,

[[Page 29516]]

OMB, Attn: FDA Desk Officer, FAX: 202-395-6974. All comments should be 
identified with the OMB control number 0910-0167. Also include the FDA 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief 
Information Officer (HFA-250), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857,301-827-4659.

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.

Orphan Drugs (OMB Control Number 0910-0167)--Extension

    Sections 525 through 526 of the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 360aa through 360dd) give FDA statutory 
authority to do the following: (1) Provide recommendations on 
investigations required for approval of marketing applications for 
orphan drugs, (2) designate eligible drugs as orphan drugs, (3) set 
forth conditions under which a sponsor of an approved orphan drug 
obtains exclusive approval, and (4) encourage sponsors to make orphan 
drugs available for treatment on an ``open protocol'' basis before the 
drug has been approved for general marketing. The implementing 
regulations for these statutory requirements have been codified under 
part 316 (21 CFR part 316) and specify procedures that sponsors of 
orphan drugs use in availing themselves of the incentives provided for 
orphan drugs in the act and sets forth procedures FDA will use in 
administering the act with regard to orphan drugs. Section 316.10 
specifies the content and format of a request for written 
recommendations concerning the non-clinical laboratory studies and 
clinical investigations necessary for approval of marketing 
applications. Section 316.12 provides that, before providing such 
recommendations, FDA may require results of studies to be submitted for 
review. Section 316.14 contains provisions permitting FDA to refuse to 
provide written recommendations under certain circumstances. Within 90 
days of any refusal, a sponsor may submit additional information 
specified by FDA. Section 316.20 specifies the content and format of an 
orphan drug application which includes requirements that an applicant 
document that the disease is rare (affects fewer than 200,000 persons 
in the United States annually) or that the sponsor of the drug has no 
reasonable expectation of recovering costs of research and development 
of the drug. Section 316.26 allows an applicant to amend the 
applications under certain circumstances. Section 316.30 requires 
submission of annual reports, including progress reports on studies, a 
description of the investigational plan, and a discussion of changes 
that may affect orphan status. The information requested will provide 
the basis for an FDA determination that the drug is for a rare disease 
or condition and satisfies the requirements for obtaining orphan drug 
status. Secondly, the information will describe the medical and 
regulatory history of the drug. The respondents to this collection of 
information are biotechnology firms, drug companies, and academic 
clinical researchers.
    The information requested from respondents represents, for the most 
part, an accounting of information already in the possession of the 
applicant. It is estimated, based on frequency of requests over the 
past 5 years, that 171 persons or organizations per year will request 
orphan-drug designation and none will request formal recommendations on 
design of preclinical or clinical studies.
    In the Federal Register of October 30, 2006 (71 FR 63325), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. FDA received one comment related to the 
information collection.
    (Comment 1) The comment suggested that our burden estimate to 
prepare an Orphan Drug Annual Report is too low.
    (Response 1) Section 316.30 pertains to annual reporting, a brief 
progress report which is a requirement after orphan designation has 
been granted to a sponsor. We estimate this takes 1 hour professional 
time and 1 hour support time.
    (Comment 2) The comment suggested that our estimate of 130 hours to 
prepare and submit an orphan drug application is too high.
    (Response 2) We disagree with the comment because some sponsors 
have more experience with submitting Orphan Drug Designation 
applications/requests and, therefore, may require less human resource 
hours to compile all required information. Many other sponsors, which 
include foreign sponsors, do not have such experience.
    The estimated 130 hours pertains to Sec. Sec.  316.20, 316.21, and 
316.26. These apply primarily to initial applications/requests seeking 
orphan drug designation. Many applications/requests received in the 
Office of Orphan Products Development contain multiple volumes; include 
an exact duplicate copy of the original; and may include 50 or more 
documented references. Additional information is requested when an 
application/request is denied. The sponsor usually supplies the 
requested information in the form of an amendment.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                          No. of       Annual Frequency     Total Annual        Hours per
   21 CFR Section       Respondents      per Response        Responses          Responses         Total Hours
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316.10, 316.12, &                  5                  1                  5                130                650
 316.14
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316.20, 316.21, &                171                  2                342                130             44,460
 316.26
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316.22                            30                  1                 30                  2                 60
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316.27                            25                  1                 25                  4                100
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316.30                           500                  1                500                  2              1,000
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316.36                            .2                  3                 .6                 15                  9
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Total                 ..............  .................  .................  .................             46,279
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\1\ There are no capital costs or maintenance costs associated with this collection of information.



[[Page 29517]]

    Dated: May 22, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-10271 Filed 5-25-07; 8:45 am]
BILLING CODE 4160-01-S