Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation, 60474-60476 [2014-23846]
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Federal Register / Vol. 79, No. 194 / Tuesday, October 7, 2014 / Notices
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2001, renewed at appropriate intervals, and
will expire on August 3, 2015.
Purpose: The Advisory Board is charged
with (a) providing advice to the Secretary,
HHS, on the development of guidelines
under Executive Order 13179; (b) providing
advice to the Secretary, HHS, on the
scientific validity and quality of dose
reconstruction efforts performed for this
program; and (c) upon request by the
Secretary, HHS, advise the Secretary on
whether there is a class of employees at any
Department of Energy facility who were
exposed to radiation but for whom it is not
feasible to estimate their radiation dose, and
on whether there is reasonable likelihood
that such radiation doses may have
endangered the health of members of this
class. The Subcommittee for Dose
Reconstruction Reviews was established to
aid the Advisory Board in carrying out its
duty to advise the Secretary, HHS, on dose
reconstruction.
Matters for Discussion: The agenda for the
Subcommittee meeting includes the
following dose reconstruction program
quality management and assurance activities:
Discussion of current findings from NIOSH
and Advisory Board dose reconstruction
blind reviews; discussion of dose
reconstruction cases under review (cases
involving Hanford, Mound Plant, Y–12, Oak
Ridge National Laboratory, Lawrence
Livermore National Laboratory, Pacific
Proving Grounds, Hooker Electrochemical,
Simonds Saw and Steel, Bethlehem Steel,
Weldon Spring, W.R. Grace, Westinghouse,
International Minerals and Chemical (IMC)
Corporation, Koppers Company, Bridgeport
Brass, Uranium Mill in Monticello, General
Steel Industries, and DuPont Deepwater
Works); and preparation of the Advisory
Board’s next report to the Secretary, HHS,
summarizing the results of completed dose
reconstruction reviews.
The agenda is subject to change as
priorities dictate.
Contact Person for More Information:
Theodore Katz, Designated Federal
Officer, NIOSH, CDC, 1600 Clifton Road
NE., Mailstop E–20, Atlanta GA 30333,
Telephone (513)533–6800, Toll Free
1(800)CDC–INFO, Email ocas@cdc.gov.
The Director, Management Analysis
and Services Office, has been delegated
the authority to sign Federal Register
notices pertaining to announcements of
meetings and other committee
management activities, for both the
Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Claudette Grant,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
[FR Doc. 2014–23857 Filed 10–6–14; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Advisory Committee on Immunization
Practices (ACIP)
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Claudette Grant,
Acting Director, Management Analysis and
Services Office, Centers for Disease Control
and Prevention.
In accordance with section 10(a) (2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC) announce
the following meeting of the
aforementioned committee.
[FR Doc. 2014–23856 Filed 10–6–14; 8:45 am]
Times and Dates:
8:00 a.m.–5:45 p.m., EDT, October 29, 2014
8:00 a.m.–1:15 p.m., EDT, October 30, 2014
Place: Centers for Disease Control and
Prevention, Tom Harkin Global
Communications Center, 1600 Clifton Road
NE., Building 19, Kent ‘‘Oz’’ Nelson
Auditorium, Atlanta, Georgia 30333.
Status: Open to the public, limited only by
the space available.
Purpose: The committee is charged with
advising the Director, CDC, on the
appropriate use of immunizing agents. In
addition, under 42 U.S.C. 1396s, the
committee is mandated to establish and
periodically review and, as appropriate,
revise the list of vaccines for administration
to vaccine-eligible children through the
Vaccines for Children (VFC) program, along
with schedules regarding the appropriate
periodicity, dosage, and contraindications
applicable to the vaccines. Further, under
provisions of the Affordable Care Act, at
section 2713 of the Public Health Service
Act, immunization recommendations of the
ACIP that have been adopted by the Director
of the Centers for Disease Control and
Prevention must be covered by applicable
health plans.
Matters for Discussion: The agenda will
include discussions on: General
recommendations; human papillomavirus
vaccines; influenza; novel influenza
vaccines, tetanus, diphtheria, and acellular
pertussis vaccine (Tdap); meningococcal
vaccines; child/adolescent immunization
schedule; adult immunization schedule;
immunization safety; hepatitis vaccines;
typhoid vaccines; and vaccine supply.
Recommendation votes are scheduled for
general recommendations, child/adolescent
immunization schedule, adult immunization
schedule and typhoid vaccines. Time will be
available for public comment.
Agenda items are subject to change as
priorities dictate. Contact Person for More
Information: Stephanie Thomas, National
Center for Immunization and Respiratory
Diseases, CDC, 1600 Clifton Road NE., MS–
A27, Atlanta, Georgia 30333, telephone 404/
639–8836; Email ACIP@CDC.GOV
Meeting is Webcast live via the World
Wide Web; for instructions and more
information on ACIP please visit the ACIP
Web site: https://www.cdc.gov/vaccines/acip/
index.html.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
Food and Drug Administration
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BILLING CODE 4160–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Docket No. FDA–2014–N–0386]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Orphan Drugs;
Common European Medicines Agency/
Food and Drug Administration
Application Form for Orphan Medicinal
Product Designation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
(PRA).
SUMMARY:
Fax written comments on the
collection of information by November
6, 2014.
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:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. 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.
DATES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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asabaliauskas on DSK5VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 194 / Tuesday, October 7, 2014 / Notices
Orphan Drugs; Common European
Medicines Agency/Food and Drug
Administration Application Form for
Orphan Medicinal Product
Designation—21 CFR Part 316 (OMB
Control Number 0910–0167)—Revision
FDA is amending the 1992 Orphan
Drug Regulations, part 316 (21 CFR part
316). The 1992 regulations were issued
to implement sections 525 through 528
of the Orphan Drug Act Amendments to
the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 360aa
through 360ee). The 1992 regulations
specify the procedures for sponsors of
orphan drugs to use in obtaining the
incentives provided for in the FD&C Act
and set forth the procedures that FDA
will use in administering the FD&C Act.
The amendments are intended to
clarify regulatory provisions and make
minor improvements to address issues
that have arisen since the issuance of
the regulations in 1992. They are
intended to assist sponsors who are
seeking and who have obtained orphan
drug designations, as well as FDA in its
administration of the orphan drug
program. Except with respect to the two
revisions addressed further, the
revisions in this rule clarify existing
language and do not constitute a
substantive or material modification to
the approved collections of information
in current part 316 (see 5 CFR
1320.5(g)). The collections of
information in current part 316 have
been approved by OMB in accordance
with the PRA under OMB control
number 0910–0167.
One revision concerns the name of the
drug in an orphan-drug designation
request. As provided in current
§ 316.20(b)(2) (Content and format of a
request for orphan-drug designation),
requests for orphan-drug designation
must include the generic and trade
name, if any, of the drug. For some
products, however, neither a generic nor
trade name may be available. This can
be the case for some large and
complicated biological products or for
any molecule for which the sponsor has
not yet obtained a trade name. Under
§ 316.20(b)(2) as revised, requests for
designation must include a chemical
name or a meaningful descriptive name
of the drug if neither a generic nor trade
name is available. Drug names need to
be meaningful to the public because the
Orphan Drug Act (Pub. L. 97–414)
requires that notice respecting
designation of a drug be made available
to the public (section 526(c) of the FD&C
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Act and § 316.28 (Publication of orphan
drug designations)). Internal business
codes or other similar identifiers do not
suffice for publication purposes, as they
do not provide meaningful notice to the
public of a designation. By providing a
chemical name or a meaningful
descriptive name of a drug in a request
for designation, if neither a generic nor
trade name is available, sponsors would
help ensure that the name of the
product that FDA ultimately publishes
upon designation is accurate and
meaningful.
FDA regulations are currently silent
on when sponsors must respond to a
deficiency letter from FDA on an
orphan-drug designation request. FDA
sends such deficiency letters when a
request lacks necessary information or
contains inaccurate information, i.e.,
miscalculated prevalence estimate. This
rule revises § 316.24(a) (Deficiency
letters and granting orphan-drug
designation) to include a requirement
that sponsors respond to deficiency
letters from FDA on designation
requests within 1 year of issuance of the
deficiency letter, unless within that time
frame the sponsor requests an extension
of time to respond. FDA will grant all
reasonable requests for an extension. In
the event the sponsor fails to respond to
the deficiency or request an extension of
time to respond within the 1-year time
frame, FDA may consider the
designation request voluntarily
withdrawn. This proposal is necessary
to ensure that designation requests do
not become ‘‘stale’’ by the time they are
granted, such that the basis for the
initial request may no longer hold.
Sections 525 through 528 of the FD&C
Act 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, specify procedures that
sponsors of orphan drugs use in availing
themselves of the incentives provided
for orphan drugs in the FD&C Act, and
set forth procedures FDA will use in
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60475
administering the FD&C 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 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, for the most part, is an
accounting of information already in the
possession of the applicant. It is
estimated, based on frequency of
requests over the past 3 years, that 275
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 April 16,
2014 (79 FR 21471), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
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60476
Federal Register / Vol. 79, No. 194 / Tuesday, October 7, 2014 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section/FDA Form
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
316.10, 316.12, and 316.14 .................................................
316.20, 316.21, and 316.26 .................................................
Form FDA 3671 ...................................................................
316.22 ..................................................................................
316.27 ..................................................................................
316.30 ..................................................................................
316.36 ..................................................................................
2
225
50
65
43
450
2
1
2
3
1
1
1
3
2
450
150
65
43
450
6
100
150
45
2
5
3
15
200
67,500
6,750
130
215
1,350
90
Total ..............................................................................
........................
........................
........................
........................
76,235
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: October 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
collection and has assigned OMB
control number 0910–0693. The
approval expires on August 31, 2017. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
[FR Doc. 2014–23846 Filed 10–6–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Dated: October 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
Food and Drug Administration
[FR Doc. 2014–23842 Filed 10–6–14; 8:45 am]
[Docket No. FDA–2014–N–0222]
BILLING CODE 4164–01–P
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Guidance for Industry on User Fee
Waivers, Reductions, and Refunds for
Drug and Biological Products
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Guidance for Industry on User Fee
Waivers, Reductions, and Refunds for
Drug and Biological Products’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On July
16, 2014, the Agency submitted a
proposed collection of information
entitled ‘‘Guidance for Industry on User
Fee Waivers, Reductions, and Refunds
for Drug and Biological Products’’ to
OMB for review and clearance under 44
U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0432]
Pathological Complete Response in
Neoadjuvant Treatment of High-Risk
Early-Stage Breast Cancer: Use as an
Endpoint To Support Accelerated
Approval; Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Pathological Complete
Response in Neoadjuvant Treatment of
High-Risk Early-Stage Breast Cancer:
Use as an Endpoint to Support
Accelerated Approval.’’ This guidance
is intended to assist applicants in
designing trials to support marketing
approval of drugs to treat breast cancer
in the neoadjuvant (preoperative) setting
using pathological complete response
(pCR) as a surrogate endpoint that could
support approval under the accelerated
approval regulations. Despite advances
in systemic therapy of early-stage breast
cancer over the past few decades, there
remains a significant unmet medical
need for certain high-risk or poor
prognosis populations of early-stage
SUMMARY:
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breast cancer patients. This guidance is
intended to encourage industry
innovation and expedite the
development of breakthrough therapies
to treat high-risk early-stage breast
cancer. This guidance finalizes the draft
guidance issued May 30, 2012.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Tatiana Prowell, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 2112,
Silver Spring, MD 20993–0002, 301–
796–2330.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Pathological Complete Response in
Neoadjuvant Treatment of High-Risk
Early-Stage Breast Cancer: Use as an
Endpoint to Support Accelerated
Approval.’’ Under the accelerated
approval regulations (21 CFR part 314,
subpart H, and 21 CFR part 601, subpart
E), FDA may grant marketing approval
for a new drug on the basis of adequate
and well-controlled trials establishing
E:\FR\FM\07OCN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 194 (Tuesday, October 7, 2014)]
[Notices]
[Pages 60474-60476]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-23846]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0386]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Orphan Drugs; Common
European Medicines Agency/Food and Drug Administration Application Form
for Orphan Medicinal Product Designation
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 (PRA).
DATES: Fax written comments on the collection of information by
November 6, 2014.
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: 202-395-7285, or emailed to oira_submission@omb.eop.gov. 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: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
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.
[[Page 60475]]
Orphan Drugs; Common European Medicines Agency/Food and Drug
Administration Application Form for Orphan Medicinal Product
Designation--21 CFR Part 316 (OMB Control Number 0910-0167)--Revision
FDA is amending the 1992 Orphan Drug Regulations, part 316 (21 CFR
part 316). The 1992 regulations were issued to implement sections 525
through 528 of the Orphan Drug Act Amendments to the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360aa through 360ee).
The 1992 regulations specify the procedures for sponsors of orphan
drugs to use in obtaining the incentives provided for in the FD&C Act
and set forth the procedures that FDA will use in administering the
FD&C Act.
The amendments are intended to clarify regulatory provisions and
make minor improvements to address issues that have arisen since the
issuance of the regulations in 1992. They are intended to assist
sponsors who are seeking and who have obtained orphan drug
designations, as well as FDA in its administration of the orphan drug
program. Except with respect to the two revisions addressed further,
the revisions in this rule clarify existing language and do not
constitute a substantive or material modification to the approved
collections of information in current part 316 (see 5 CFR 1320.5(g)).
The collections of information in current part 316 have been approved
by OMB in accordance with the PRA under OMB control number 0910-0167.
One revision concerns the name of the drug in an orphan-drug
designation request. As provided in current Sec. 316.20(b)(2) (Content
and format of a request for orphan-drug designation), requests for
orphan-drug designation must include the generic and trade name, if
any, of the drug. For some products, however, neither a generic nor
trade name may be available. This can be the case for some large and
complicated biological products or for any molecule for which the
sponsor has not yet obtained a trade name. Under Sec. 316.20(b)(2) as
revised, requests for designation must include a chemical name or a
meaningful descriptive name of the drug if neither a generic nor trade
name is available. Drug names need to be meaningful to the public
because the Orphan Drug Act (Pub. L. 97-414) requires that notice
respecting designation of a drug be made available to the public
(section 526(c) of the FD&C Act and Sec. 316.28 (Publication of orphan
drug designations)). Internal business codes or other similar
identifiers do not suffice for publication purposes, as they do not
provide meaningful notice to the public of a designation. By providing
a chemical name or a meaningful descriptive name of a drug in a request
for designation, if neither a generic nor trade name is available,
sponsors would help ensure that the name of the product that FDA
ultimately publishes upon designation is accurate and meaningful.
FDA regulations are currently silent on when sponsors must respond
to a deficiency letter from FDA on an orphan-drug designation request.
FDA sends such deficiency letters when a request lacks necessary
information or contains inaccurate information, i.e., miscalculated
prevalence estimate. This rule revises Sec. 316.24(a) (Deficiency
letters and granting orphan-drug designation) to include a requirement
that sponsors respond to deficiency letters from FDA on designation
requests within 1 year of issuance of the deficiency letter, unless
within that time frame the sponsor requests an extension of time to
respond. FDA will grant all reasonable requests for an extension. In
the event the sponsor fails to respond to the deficiency or request an
extension of time to respond within the 1-year time frame, FDA may
consider the designation request voluntarily withdrawn. This proposal
is necessary to ensure that designation requests do not become
``stale'' by the time they are granted, such that the basis for the
initial request may no longer hold.
Sections 525 through 528 of the FD&C Act 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, specify procedures that sponsors of orphan drugs use in
availing themselves of the incentives provided for orphan drugs in the
FD&C Act, and set forth procedures FDA will use in administering the
FD&C 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 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, for the most part, is
an accounting of information already in the possession of the
applicant. It is estimated, based on frequency of requests over the
past 3 years, that 275 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 April 16, 2014 (79 FR 21471), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
[[Page 60476]]
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section/FDA Form Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
316.10, 316.12, and 316.14...... 2 1 2 100 200
316.20, 316.21, and 316.26...... 225 2 450 150 67,500
Form FDA 3671................... 50 3 150 45 6,750
316.22.......................... 65 1 65 2 130
316.27.......................... 43 1 43 5 215
316.30.......................... 450 1 450 3 1,350
316.36.......................... 2 3 6 15 90
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Total....................... .............. .............. .............. .............. 76,235
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: October 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-23846 Filed 10-6-14; 8:45 am]
BILLING CODE 4164-01-P
