Guidance for Industry on Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention; Availability, 38319-38320 [2014-15801]
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Federal Register / Vol. 79, No. 129 / Monday, July 7, 2014 / Notices
introduction of new products or at
inspection). The license holder is
responsible for reporting these changes
to FDA (§ 601.12).
2. Notification of Results of Tests and
Investigations Regarding or Possibly
Impacting the Product
In the guidance, we recommend the
following for contract manufacturing
arrangements:
• The contract manufacturer should
fully inform the license manufacturer of
the results of all tests and investigations
regarding or possibly having an impact
on the product; and
• The license manufacturer should
obtain assurance from the contractor
that any FDA list of inspectional
observations will be shared with the
license manufacturer to allow
evaluation of its impact on the purity,
potency, and safety of the license
manufacturer’s product.
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3. Notification of Products
Manufactured in a Contract Facility
In the guidance, we recommend for
contract manufacturing arrangements
that a license manufacturer cross
reference a contract manufacturing
facility’s Master Files only in
circumstances involving certain
proprietary information of the contract
manufacturer, such as a list of all
products manufactured in a contract
facility. In this situation, the license
manufacturer should be kept informed
of the types or categories of all products
manufactured in the contract facility.
4. Standard Operating Procedures
In the guidance, we remind the
license manufacture that the license
manufacturer assumes responsibility for
compliance with the applicable product
and establishment standards (21 CFR
600.3(t)). Therefore, if the license
manufacturer enters into an agreement
with a contract manufacturing facility,
the license manufacturer must ensure
that the facility complies with the
applicable standards. An agreement
between a license manufacturer and a
contract manufacturing facility normally
includes procedures to regularly assess
the contract manufacturing facility’s
compliance. These procedures may
include, but are not limited to, review
of records and manufacturing deviations
and defects, and periodic audits.
For shared manufacturing
arrangements, each manufacturer must
submit a separate biologics license
application (BLA) describing the
manufacturing facilities and operations
applicable to the preparation of that
manufacturer’s biological substance or
product (§ 601.2(a)). In the guidance, we
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state that we expect the manufacturer
that prepares (or is responsible for the
preparation of) the product in final form
for commercial distribution to assume
primary responsibility for providing
data demonstrating the safety, purity,
and potency of the final product. We
also state that we expect the licensed
finished product manufacturer to be
primarily responsible for any
postapproval obligations, such as
postmarketing clinical trials, additional
product stability studies, complaint
handling, recalls, postmarket reporting
of the dissemination of advertising and
promotional labeling materials as
required under § 601.12(f)(4) and
adverse experience reporting. We
recommend that the final product
manufacturer establish a procedure with
the other participating manufacturer(s)
to obtain information in these areas.
Description of Respondents: The
recordkeeping and reporting
recommendations described in this
document affect the participating
licensed manufacturer(s), final product
manufacturer(s), and contract
manufacturer(s) associated with
cooperative manufacturing
arrangements.
Burden Estimate: We believe that the
information collection provisions in the
guidance do not create a new burden for
respondents. We believe the reporting
and recordkeeping provisions are part of
usual and customary business practices.
Licensed manufacturers would have
contractual agreements with
participating licensed manufacturers,
final product manufacturers, and
contract manufacturers, as applicable
for the type of cooperative
manufacturing arrangement, to address
all these information collection
provisions.
The guidance also refers to previously
approved collections of information
found in FDA regulations at parts 201,
207, 211, 600, 601, 606, 607, 610, 660,
801, 803, and 807, 809, and 820 (21 CFR
parts 201, 207, 211, 600, 601, 606, 607,
610, 660, 801, 803, 807, 809, and 820).
The collections of information in
§§ 606.121, 606.122, and 610.40 have
been approved under OMB control
number 0910–0116; § 610.2 has been
approved under OMB control number
0910–0206; §§ 600.12(e) and 600.80
have been approved under OMB control
number 0910–0308; §§ 601.2(a), 601.12,
610.60 through 610.65, 610.67, 660.2(c),
660.28(a) and (b), 660.35(a), (c) through
(g), (i) through (m), 660.45, and
660.55(a) and (b) have been approved
under OMB control number 0910–0338;
§§ 803.20, 803.50, and 803.53 have been
approved under OMB control number
0910–0437; and §§ 600.14 and 606.171
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
38319
have been approved under OMB control
number 0910–0458. The current good
manufacturing practice regulations for
finished pharmaceuticals (part 211)
have been approved under OMB control
number 0910–0139; §§ 820.181 and
820.184 have been approved under
OMB control number 0910–0073; the
establishment registration regulations
(parts 207, 607, and 807) have been
approved under OMB control numbers
0910–0045, 0910–0052, and 0910–0625;
and the labeling regulations (parts 201,
801, and 809) have been approved
under OMB control numbers 0910–
0537, 0910–0572, and 0910–0485.
Dated: July 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–15810 Filed 7–3–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0587]
Guidance for Industry on Neglected
Tropical Diseases of the Developing
World: Developing Drugs for
Treatment or Prevention; 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 ‘‘Neglected Tropical Diseases of
the Developing World: Developing
Drugs for Treatment or Prevention.’’ The
purpose of the guidance is to assist
sponsors in the development of drugs
for the treatment or prevention of
neglected tropical diseases (NTDs). This
guidance represents the FDA’s current
thinking regarding drug development
for the treatment or prevention of NTDs,
including clinical trial designs and
internal review standards to support
approval of drugs. This guidance
finalizes the draft guidance issued
August 24, 2011.
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, 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
SUMMARY:
E:\FR\FM\07JYN1.SGM
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38320
Federal Register / Vol. 79, No. 129 / Monday, July 7, 2014 / Notices
mstockstill on DSK4VPTVN1PROD with NOTICES
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:
Joseph G. Toerner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6244,
Silver Spring, MD 20993–0002, 301–
796–1300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Neglected Tropical Diseases of the
Developing World: Developing Drugs for
Treatment or Prevention.’’ The purpose
of this guidance is to assist sponsors in
the development of drugs for the
treatment or prevention of NTDs as
defined in section 524(a)(3) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 360n(a)(3)).
NTDs are infectious diseases that are
generally rare or absent in developed
countries, but are often widespread in
developing countries. The availability of
new drugs that are safe and effective for
treatment or prevention of NTDs could
provide public health benefit for overall
global health.
This guidance addresses general
issues in drug development and
implementation of clinical trials for
NTDs. FDA will review and comment
on drug development plans and will
review new drug applications or
biologics license applications for new
drugs for NTDs, regardless of where the
clinical development program takes
place. Specifically, the guidance
provides a general overview of
nonclinical development
considerations, as well as clinical
development considerations and
regulatory paradigms. Other activities in
the Center for Drug Evaluation and
Research that pertain to NTDs are
summarized in the guidance. Listings of
guidance documents that are most
relevant to drug development for NTDs
are included in the guidance.
This guidance finalizes the draft
guidance issued August 24, 2011.
Comments on the draft guidance were
considered while finalizing this
guidance. Specifically, changes from the
draft guidance include descriptions of
new regulatory designations (Qualified
Infectious Disease Product;
Breakthrough Therapy).
VerDate Mar<15>2010
15:59 Jul 03, 2014
Jkt 232001
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 developing drugs
for the treatment or prevention of
neglected tropical diseases of the
developing world. 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 312 and
21 CFR part 314 have been approved
under OMB control numbers 0910–0014
and 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 http:
//www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: July 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–15801 Filed 7–3–14; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0001]
Pediatric Advisory Committee; Notice
of Meeting
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00045
Fmt 4703
Sfmt 4703
ACTION:
Notice.
This notice announces a forthcoming
meeting of a public advisory committee
of the Food and Drug Administration
(FDA). The meeting will be open to the
public.
Name of Committee: Pediatric
Advisory Committee.
General Function of the Committee:
To provide advice and
recommendations to the Agency on
FDA’s regulatory issues.
Date and Time: The meeting will be
held on September 23, 2014, from 8 a.m.
to 5:30 p.m.
Location: Bethesda Marriott, 5151
Pooks Hill Rd., Bethesda, MD 20814.
Contact Person: Walter Ellenberg,
Office of the Commissioner, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 32, Rm. 5154,
Silver Spring, MD 20993–0002, 301–
796–0885, or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). A notice in the Federal Register
about last minute modifications that
impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the Agency’s Web
site at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee link, or call the advisory
committee information line to learn
about possible modifications before
coming to the meeting.
Agenda: The Pediatric Advisory
Committee will meet to discuss
pediatric-focused safety reviews, as
mandated by the Best Pharmaceuticals
for Children Act and the Pediatric
Research Equity Act for: AFINITOR
DISPERZ (everolimus); Berlin Heart
EXCOR® Pediatric Ventricular Assist
Device; CONTEGRA® Pulmonary
Valved Conduit; DYMISTA (azelastine
hydrochloride; fluticasone propionate);
Elana Surgical Kit; ENTERRA Therapy
System; LEVAQUIN (levofloxacin);
LEXIVA (fosamprenavir calcium);
QNASL (beclomethasone
diproprionate), Medtronic Melody®
Transcatheter Pulmonary Valve;
MENHIBRIX (Meningococcal Groups C
and Y and Haemophilus b Tetanus
Toxoid Conjugate Vaccine); SINGULAIR
(montelukast sodium); TREANDA
(bendamustine hydrochloride);
VERAMYST (fluticasone furoate);
VIREAD (tenofovirdisoproxil fumarate);
and VOLUVEN (6% hydroxyethyl starch
130/0.4 in 0.9% sodium chloride
injection).
FDA intends to make background
material available to the public no later
E:\FR\FM\07JYN1.SGM
07JYN1
Agencies
[Federal Register Volume 79, Number 129 (Monday, July 7, 2014)]
[Notices]
[Pages 38319-38320]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-15801]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-D-0587]
Guidance for Industry on Neglected Tropical Diseases of the
Developing World: Developing Drugs for Treatment or Prevention;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Neglected Tropical
Diseases of the Developing World: Developing Drugs for Treatment or
Prevention.'' The purpose of the guidance is to assist sponsors in the
development of drugs for the treatment or prevention of neglected
tropical diseases (NTDs). This guidance represents the FDA's current
thinking regarding drug development for the treatment or prevention of
NTDs, including clinical trial designs and internal review standards to
support approval of drugs. This guidance finalizes the draft guidance
issued August 24, 2011.
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, 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
[[Page 38320]]
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: Joseph G. Toerner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6244, Silver Spring, MD 20993-0002, 301-
796-1300.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Neglected Tropical Diseases of the Developing World:
Developing Drugs for Treatment or Prevention.'' The purpose of this
guidance is to assist sponsors in the development of drugs for the
treatment or prevention of NTDs as defined in section 524(a)(3) of the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n(a)(3)).
NTDs are infectious diseases that are generally rare or absent in
developed countries, but are often widespread in developing countries.
The availability of new drugs that are safe and effective for treatment
or prevention of NTDs could provide public health benefit for overall
global health.
This guidance addresses general issues in drug development and
implementation of clinical trials for NTDs. FDA will review and comment
on drug development plans and will review new drug applications or
biologics license applications for new drugs for NTDs, regardless of
where the clinical development program takes place. Specifically, the
guidance provides a general overview of nonclinical development
considerations, as well as clinical development considerations and
regulatory paradigms. Other activities in the Center for Drug
Evaluation and Research that pertain to NTDs are summarized in the
guidance. Listings of guidance documents that are most relevant to drug
development for NTDs are included in the guidance.
This guidance finalizes the draft guidance issued August 24, 2011.
Comments on the draft guidance were considered while finalizing this
guidance. Specifically, changes from the draft guidance include
descriptions of new regulatory designations (Qualified Infectious
Disease Product; Breakthrough Therapy).
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 developing drugs for the treatment or
prevention of neglected tropical diseases of the developing world. 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 312 and 21 CFR
part 314 have been approved under OMB control numbers 0910-0014 and
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: July 1, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-15801 Filed 7-3-14; 8:45 am]
BILLING CODE 4164-01-P