[Federal Register: May 29, 2007 (Volume 72, Number 102)]
[Notices]
[Page 29515-29517]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr29my07-55]
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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