Draft Guidance for Industry on Chronic Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products for Treatment; Availability, 13658-13659 [2014-05189]
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Federal Register / Vol. 79, No. 47 / Tuesday, March 11, 2014 / Notices
5. The verification required under
section 505(q)(1)(I) of the FD&C Act for
supplements to citizen petitions.
6. Supplements to petitions for stay of
agency action.
7. The verification required under
section 505(q)(1)(I) of the FD&C Act for
supplements to petitions for stay of
agency action.
8. The letter submitted by a petitioner
withdrawing a deficient petition for stay
of agency action that is missing the
required certification but is otherwise
within the scope of section 505(q) of the
FD&C Act.
Section 505(q)(1)(B) and (C) of the
FD&C Act and the guidance state that if
FDA determines that a delay in approval
of an ANDA, section 505(b)(2)
application, or biosimilar biological
product application is necessary based
on a petition subject to section 505(q),
the applicant may submit to the petition
docket clarifications or additional data
to allow FDA to review the petition
promptly. This information collection is
not included in this analysis because it
is approved under OMB control number
0910–0001.
In the Federal Register of October 1,
2013 (78 FR 60288), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received that pertained to the
information collection analysis.
Based on FDA’s knowledge of citizen
petitions and petitions for stay of agency
action subject to section 505(q) of the
FD&C Act that have been submitted to
FDA, as well as the Agency’s familiarity
with the time needed to prepare a
supplement, a certification, and a
verification, FDA estimates the burden
of this collection of information as
follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
responses per
respondent
Number of
respondents
Activity
Total
annual
responses
Average
burden per
response
Total hours
Certification for citizen petitions (505(q)(1)(H)) ...................
Certification for petitions for stay of agency action
(505(q)(1)(H)) ...................................................................
Verification for comments to citizen petitions (505(q)(1)(I))
Verification for comments to petitions for stay of agency
action (505(q)(1)(I)) ..........................................................
Verification for supplements to citizen petitions
(505(q)(1)(I)) .....................................................................
Supplements to petitions for stay of agency action ............
Verification for supplements to petitions for stay of agency
action (505(q)(1)(I)) ..........................................................
Letter withdrawing a petition for stay of agency action .......
26
1.15
32
0.5 (30 min.)
16
1
9
1
1.33
1
12
0.5 (30 min.)
0.5 (30 min.)
0.5
6
1
1
1
0.5 (30 min.)
0.5
7
1
1.43
1
10
1
0.5 (30 min.)
6
5
6
1
1
1
1
1
1
0.5 (30 min.)
0.5 (30 min.)
0.5
0.5
Total Hours ...................................................................
........................
35
........................
........................
........................
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 5, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
treatment of chronic fatigue syndrome/
myalgic encephalomyelitis (CFS/ME).
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by May 12, 2014.
DATES:
[FR Doc. 2014–05190 Filed 3–10–14; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Draft Guidance for Industry on Chronic
Fatigue Syndrome/Myalgic
Encephalomyelitis: Developing Drug
Products for Treatment; Availability
AGENCY:
Food and Drug Administration,
HHS.
emcdonald on DSK67QTVN1PROD with NOTICES
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Chronic Fatigue
Syndrome/Myalgic Encephalomyelitis:
Developing Drug Products for
Treatment.’’ The purpose of this draft
guidance is to assist sponsors in the
development of drug products for the
SUMMARY:
VerDate Mar<15>2010
17:22 Mar 10, 2014
Jkt 232001
Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
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 draft guidance document.
Submit electronic comments on the
draft 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.
ADDRESSES:
[Docket No. FDA–2014–D–0264]
PO 00000
Frm 00049
Fmt 4703
Sfmt 4703
FOR FURTHER INFORMATION CONTACT:
Janet Maynard, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3185,
Silver Spring, MD 20993–0002, 301–
796–2300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Chronic Fatigue Syndrome/Myalgic
Encephalomyelitis: Developing Drug
Products for Treatment.’’ The purpose of
this draft guidance is to assist sponsors
in the development of drug products for
the treatment of CFS/ME.
Currently, there are no approved
therapies indicated to treat CFS/ME.
The lack of approved therapies
indicated for the treatment of CFS/ME
represents a public health concern. To
foster drug development in CFS/ME,
this draft guidance outlines the
following key issues in drug
development in CFS/ME:
• The case definitions or criteria for
CFS/ME that could be used to define a
patient population in the context of
drug development
E:\FR\FM\11MRN1.SGM
11MRN1
Federal Register / Vol. 79, No. 47 / Tuesday, March 11, 2014 / Notices
• Recommendations for establishing
efficacy in CFS/ME based on patientreported symptoms and measurements
of exercise capacity
• Recommended trial design and
duration
• Recommendations for establishing
safety in CFS/ME
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on developing drug products for the
treatment of CFS/ME. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
II. The Paperwork Reduction Act of
1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
emcdonald on DSK67QTVN1PROD with NOTICES
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://www.
regulations.gov.
Dated: March 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–05189 Filed 3–10–14; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
17:22 Mar 10, 2014
Jkt 232001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Amended Notice of Meeting
Notice is hereby given of a change in
the meeting of the National Institute of
Mental Health Special Emphasis Panel,
March 17, 2014, 01:00 p.m. to March 17,
2014, 03:00 p.m., National Institutes of
Health, Neuroscience Center, 6001
Executive Boulevard, Rockville, MD
20852 which was published in the
Federal Register on February 18, 2014,
79 FRN 9245.
The panel name has been changed to
‘‘NIMH R25 HIV/AIDS
APPLICATIONS.’’ The previous notice
incorrectly listed these as ‘‘R34’’
applications. This meeting will remain
at the same time and is closed to the
public.
Dated: March 5, 2014.
Carolyn A. Baum,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–05166 Filed 3–10–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Research
Program Project: Genome-Scale Data Analysis
Review.
Date: April 2–3, 2014.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Mark Caprara, Ph.D.,
Scientific Review Officer, Center for
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
13659
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5156,
MSC 7844, Bethesda, MD 20892, 301–435–
1042, capraramg@mail.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AREA:
Endocrinology, Metabolism and Nutrition.
Date: April 3, 2014.
Time: 7:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Nancy Sheard, SCD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6046–E,
MSC 7892, Bethesda, MD 20892, 301–408–
9901, sheardn@csr.nih.gov.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Program
Project: Iron Homeostasis Regulation.
Date: April 3–4, 2014.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting),
Contact Person: Nitsa Rosenzweig, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 1102,
MSC 7760, Bethesda, MD 20892, (301) 435–
1747, rosenzweign@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS).
Dated: March 4, 2014.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–05161 Filed 3–10–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center For Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
E:\FR\FM\11MRN1.SGM
11MRN1
]]>Agencies
[Federal Register Volume 79, Number 47 (Tuesday, March 11, 2014)]
[Notices]
[Pages 13658-13659]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-05189]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0264]
Draft Guidance for Industry on Chronic Fatigue Syndrome/Myalgic
Encephalomyelitis: Developing Drug Products for Treatment; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Chronic
Fatigue Syndrome/Myalgic Encephalomyelitis: Developing Drug Products
for Treatment.'' The purpose of this draft guidance is to assist
sponsors in the development of drug products for the treatment of
chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME).
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 12, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, 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 draft guidance document.
Submit electronic comments on the draft 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: Janet Maynard, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3185, Silver Spring, MD 20993-0002, 301-
796-2300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Chronic Fatigue Syndrome/Myalgic Encephalomyelitis:
Developing Drug Products for Treatment.'' The purpose of this draft
guidance is to assist sponsors in the development of drug products for
the treatment of CFS/ME.
Currently, there are no approved therapies indicated to treat CFS/
ME. The lack of approved therapies indicated for the treatment of CFS/
ME represents a public health concern. To foster drug development in
CFS/ME, this draft guidance outlines the following key issues in drug
development in CFS/ME:
The case definitions or criteria for CFS/ME that could be
used to define a patient population in the context of drug development
[[Page 13659]]
Recommendations for establishing efficacy in CFS/ME based
on patient-reported symptoms and measurements of exercise capacity
Recommended trial design and duration
Recommendations for establishing safety in CFS/ME
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on developing
drug products for the treatment of CFS/ME. It does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. An alternative approach may be used if such approach satisfies
the requirements of the applicable statutes and regulations.
II. The Paperwork Reduction Act of 1995
This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 314 have been
approved under OMB control number 0910-0001.
III. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: March 6, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-05189 Filed 3-10-14; 8:45 am]
BILLING CODE 4160-01-P
