[Federal Register: May 27, 2004 (Volume 69, Number 103)]
[Notices]
[Page 30314-30315]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27my04-66]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004N-0046]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Orphan Drug Products
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 June
28, 2004
ADDRESSES: OMB is still experiencing significant delays in the regular
mail, including first class and express mail, and messenger deliveries
are not being accepted. 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: Fumie
Yokota, Desk Officer for FDA, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of Management
Programs (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 Drug Products--(OMB Control Number 0910-0167)--Extension
Sections 525 through 528 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 nonclinical 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 than 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
application 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.
In the Federal Register of February 24, 2004 (69 FR 8447) FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 30315]]
Table 1.--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual Frequency Total Annual Hours per
21 CFR Section No. of Respondents of response Responses Response Total Hours
----------------------------------------------------------------------------------------------------------------
316.10, 316.12, and 316.14 3 1 3 130 390
----------------------------------------------------------------------------------------------------------------
316.20, 316.21, and 316.26 138 2.0 276 130 35,880
----------------------------------------------------------------------------------------------------------------
316.22 22 1 22 2 44
----------------------------------------------------------------------------------------------------------------
316.27 5 1 5 4 20
----------------------------------------------------------------------------------------------------------------
316.30 500 1 500 2 1,000
----------------------------------------------------------------------------------------------------------------
316.36 .2 3 .6 15 9
----------------------------------------------------------------------------------------------------------------
Total .................. .................. .............. ............ 37,343
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
The information requested from respondents represents, for the most
part, an accounting of information already in possession of the
applicant. It is estimated, based on the frequency of requests over the
past 13 years that 138 persons or organizations per year will request
orphan drug designation and that no requests for recommendations on
design of preclinical or clinical studies will be received. Based upon
FDA experience over the last decade, FDA estimates that the effort
required to prepare applications to receive consideration for sections
525 and 526 of the act (Sec. Sec. 316.10, 316.12, 316.20, and 316.21)
is generally similar and is estimated to require an average of 95 hours
of professional staff time and 30 hours of support staff time per
application. Estimates of annual activity and burden for foreign
sponsor nomination of a resident, agent, change in ownership or
designation, and inadequate supplies of drug in exclusivity, are based
on total experience by FDA with such requests since 1983.
Dated: May 21, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-12010 Filed 5-26-04; 8:45 am]
BILLING CODE 4160-01-S