Migraine: Developing Drugs for Acute Treatment; Draft Guidance for Industry; Availability, 63129-63130 [2014-25048]
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Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Notices
comment on the proposed collection of
information. No comments were
received.
We estimate the annual burden of this
collection of information as follows:
section 403A(b) of the FD&C Act for
granting exemption from Federal
preemption.
In the Federal Register of August 7,
2014 (79 FR 46269), FDA published a
60-day notice requesting public
state is required to submit in such a
petition. The information required
under § 100.1(d) enables FDA to
determine whether the state food
labeling or standard of identity
requirement satisfies the criteria of
63129
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR 100.1(d)
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Avg. burden per
response
Total hours
Form of petition ................................................
1
1
1
40
40
1
There are no capital costs or operating and maintenance costs associated with this collection of information.
The reporting burden for § 100.1(d) is
minimal because petitions for
exemption from preemption are seldom
submitted by states. In the last 3 years,
we have received one new petition for
exemption from preemption; therefore,
we estimate that one or fewer petitions
will be submitted annually.
Dated: October 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–25106 Filed 10–21–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–1540]
Migraine: Developing Drugs for Acute
Treatment; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Migraine: Developing
Drugs for Acute Treatment.’’ The
purpose of this guidance is to assist
sponsors in the clinical development of
drugs for the acute treatment of
migraine. This guidance focuses on
specific drug development and trial
design issues that are unique to the
study of drugs for the acute treatment of
migraine. This guidance is intended to
serve as a focus for continued
discussions among the Division of
Neurology Products, pharmaceutical
sponsors, the academic community, and
the public.
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
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:22 Oct 21, 2014
Jkt 235001
final version of the guidance, submit
either electronic or written comments
on the draft guidance by December 22,
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, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993.
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: Eric
Bastings, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 4338, Silver Spring,
MD 20993–0002, 301–796–1039.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Migraine: Developing Drugs for Acute
Treatment.’’ The purpose of this
guidance is to assist sponsors in the
clinical development of drugs for the
acute treatment of migraine. This
guidance focuses on specific drug
development and trial design issues that
are unique to the study of drugs for the
acute treatment of migraine. This
guidance is intended to serve as a focus
for continued discussions among the
Division of Neurology Products,
pharmaceutical sponsors, the academic
community, and the public.
Migraine is a chronic neurovascular
disorder characterized by recurrent
attacks of often severe headache,
typically presenting with nausea,
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
vomiting, and sensitivity to light and/or
sound. Pharmacologic approaches to the
treatment of migraine include drugs to
treat acute migraine attacks as they arise
(acute treatment of migraine) and drugs
to reduce the frequency of migraine
attacks (preventive treatment). This
guidance addresses the development
program of drugs for the acute treatment
of migraine, including trial population,
trial design, dose selection, efficacy
endpoints, and statistical
considerations. The guidance also
discusses safety considerations,
pediatric studies, and labeling
considerations.
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 drugs for the acute
treatment of migraine. 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 parts 201, 312,
and 314 have been approved under
OMB control numbers 0910–0572,
0910–0014, and 0910–0001,
respectively.
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
E:\FR\FM\22OCN1.SGM
22OCN1
63130
Federal Register / Vol. 79, No. 204 / Wednesday, October 22, 2014 / Notices
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/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: October 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
I. Background
[FR Doc. 2014–25048 Filed 10–21–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0710]
Guidance for Industry on
Circumstances That Constitute
Delaying, Denying, Limiting, or
Refusing a Drug Inspection;
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 ‘‘Circumstances that Constitute
Delaying, Denying, Limiting, or
Refusing a Drug Inspection.’’ The Food
and Drug Administration Safety and
Innovation Act (FDASIA) added a
provision to the Food, Drug, and
Cosmetic Act (the FD&C Act)
concerning inspections that makes a
drug adulterated. This guidance defines
the types of actions, inaction, and
circumstances that FDA considers to
constitute delaying, denying, or limiting
inspection, or refusing to permit entry
or inspection for the purposes of making
a drug adulterated.
DATES: Submit either electronic or
written comments on Agency guidance
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Office of Policy and Risk Management,
Office of Regulatory Affairs, Food and
Drug Administration, 12420 Parklawn
Dr., rm. 4138, Rockville, MD 20857.
Send one self-addressed adhesive label
to assist that office in processing your
requests. See the SUPPLEMENTARY
mstockstill on DSK4VPTVN1PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
18:22 Oct 21, 2014
Jkt 235001
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:
Emily M. Leongini, Office of Policy and
Risk Management, Office of Regulatory
Affairs, Food and Drug Administration,
10902 New Hampshire Ave., Bldg. 32,
rm. 4339, Silver Spring, MD 20903,
301–796–5300.
SUPPLEMENTARY INFORMATION:
FDA is announcing the availability of
a guidance for industry entitled
‘‘Circumstances that Constitute
Delaying, Denying, Limiting, or
Refusing a Drug Inspection.’’ On July 9,
2012, FDASIA (Pub. L. 112–144) was
signed into law. Section 707 of FDASIA
adds 501(j) to the FD&C Act to make a
drug adulterated that ‘‘has been
manufactured, processed, packed, or
held in any factory, warehouse, or
establishment and the owner, operator,
or agent of such factory, warehouse, or
establishment delays, denies, or limits
an inspection, or refuses to permit entry
or inspection.’’ As required by Section
707, FDA is issuing this guidance to
define the types of action, inaction, and
circumstances that FDA considers to
constitute delaying, denying, or limiting
inspection, or refusing to permit entry
or inspection for the purposes of Section
501(j) of the FD&C Act.
In July 2013, FDA issued a draft
guidance for industry of the same title
(78 FR 42387, July 15, 2013). In
response to docket comments, we
revised the guidance to clarify FDA’s
expectations regarding the types of
action, inaction, and circumstances that
make a drug adulterated under 501(j) of
the FD&C Act. Among other things, we
added examples that may constitute
reasonable explanations for actions,
inactions, or circumstances that could
otherwise be considered delaying,
denying, or limiting inspection, or
refusing to permit entry or inspection.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on ‘‘Circumstances that
Constitute Delaying, Denying, Limiting,
or Refusing a Drug Inspection.’’ 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
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
satisfies the requirements of the
applicable statutes and regulations.
II. 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.
III. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Regulatory
Information/Guidances/ucm122044.htm
or https://www.regulations.gov.
Dated: October 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–25033 Filed 10–21–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Seventh Annual Sentinel Initiative;
Public Workshop
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of public workshop.
The Food and Drug Administration
(FDA) is announcing a public workshop
entitled ‘‘Seventh Annual Sentinel
Initiative Public Workshop.’’ Convened
by the Engelberg Center for Health Care
Reform at the Brookings Institution and
supported by a cooperative agreement
with FDA, this 1-day workshop will
bring the stakeholder community
together to discuss a variety of topics on
active medical product surveillance.
Topics will include an overview of the
transition from the Mini-Sentinel pilot
program to the full Sentinel System and
what that means for patients and other
critical stakeholders. Additionally,
panelists will discuss the future of the
Sentinel System and opportunities to
expand its medical product surveillance
capabilities. This workshop will also
engage stakeholders to discuss current
and emerging Sentinel projects.
E:\FR\FM\22OCN1.SGM
22OCN1
]]>Agencies
[Federal Register Volume 79, Number 204 (Wednesday, October 22, 2014)]
[Notices]
[Pages 63129-63130]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-25048]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-1540]
Migraine: Developing Drugs for Acute Treatment; Draft Guidance
for Industry; 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 ``Migraine:
Developing Drugs for Acute Treatment.'' The purpose of this guidance is
to assist sponsors in the clinical development of drugs for the acute
treatment of migraine. This guidance focuses on specific drug
development and trial design issues that are unique to the study of
drugs for the acute treatment of migraine. This guidance is intended to
serve as a focus for continued discussions among the Division of
Neurology Products, pharmaceutical sponsors, the academic community,
and the public.
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 December 22, 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, 10001 New
Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD
20993. 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: Eric Bastings, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4338, Silver Spring, MD 20993-0002, 301-
796-1039.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Migraine: Developing Drugs for Acute Treatment.'' The
purpose of this guidance is to assist sponsors in the clinical
development of drugs for the acute treatment of migraine. This guidance
focuses on specific drug development and trial design issues that are
unique to the study of drugs for the acute treatment of migraine. This
guidance is intended to serve as a focus for continued discussions
among the Division of Neurology Products, pharmaceutical sponsors, the
academic community, and the public.
Migraine is a chronic neurovascular disorder characterized by
recurrent attacks of often severe headache, typically presenting with
nausea, vomiting, and sensitivity to light and/or sound. Pharmacologic
approaches to the treatment of migraine include drugs to treat acute
migraine attacks as they arise (acute treatment of migraine) and drugs
to reduce the frequency of migraine attacks (preventive treatment).
This guidance addresses the development program of drugs for the acute
treatment of migraine, including trial population, trial design, dose
selection, efficacy endpoints, and statistical considerations. The
guidance also discusses safety considerations, pediatric studies, and
labeling considerations.
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
drugs for the acute treatment of migraine. 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 parts 201, 312, and 314
have been approved under OMB control numbers 0910-0572, 0910-0014, and
0910-0001, respectively.
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
[[Page 63130]]
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: October 15, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-25048 Filed 10-21-14; 8:45 am]
BILLING CODE 4164-01-P
