[Federal Register Volume 71, Number 209 (Monday, October 30, 2006)]
[Notices]
[Pages 63325-63327]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-18067]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006N-0420]


Agency Information Collection Activities; Proposed Collection; 
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 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 the procedures by which 
sponsors of orphan drugs may request eligibility for the incentives by 
implementing a program as outlined in the Orphan Drug Act.

DATES: Submit written or electronic comments on the collection of 
information by December 29, 2006.

ADDRESSES: Submit electronic comments on the collection of

[[Page 63326]]

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: 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: 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 
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.

Orphan Drugs--21 CFR 316 (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 360 dd) 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.
    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                2.0                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 63327]]

    Dated: October 23, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-18067 Filed 10-27-06; 8:45 am]
BILLING CODE 4160-01-S