Advisory Committee; Gastrointestinal Drugs Advisory Committee, Renewal, 13135-13136 [2018-06063]
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Federal Register / Vol. 83, No. 59 / Tuesday, March 27, 2018 / Notices
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comment does not include any
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anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
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comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
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do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–0943 for ‘‘Elemental Impurities
in Animal Drug Products—Questions
and Answers.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
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• Confidential Submissions—To
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‘‘THIS DOCUMENT CONTAINS
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second copy, which will have the
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both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
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18:07 Mar 26, 2018
Jkt 244001
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the guidance to the Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT:
Michael Brent, Center for Veterinary
Medicine (HFV–140), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0647,
email: michael.brent@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
II. Significance of Guidance
This level 1 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 current
thinking of FDA on ‘‘Elemental
Impurities in Animal Drug Products—
Questions and Answers.’’ It does not
establish any rights for any person and
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III. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information 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 section 512(n)(1) of
the FD&C Act (21 U.S.C. 360b(n)(1))
have been approved under OMB control
number 0910–0669. The collections of
information in 21 CFR 514.1 and 514.8
have been approved under OMB control
number 0910–0032.
IV. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/AnimalVeterinary/
GuidanceComplianceEnforcement/
GuidanceforIndustry/default.htm or
https://www.regulations.gov.
Dated: March 20, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–06061 Filed 3–26–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0001]
Advisory Committee; Gastrointestinal
Drugs Advisory Committee, Renewal
Food and Drug Administration,
HHS.
FDA is announcing the availability of
a draft GFI #255 entitled ‘‘Elemental
Impurities in Animal Drug Products—
Questions and Answers.’’ This
document provides recommendations to
sponsors regarding the control of
elemental impurities in animal drug
products, including all dosage forms
and routes of administration.
PO 00000
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations. This
guidance is not subject to Executive
Order 12866.
AGENCY:
I. Background
13135
Sfmt 4703
Notice; renewal of advisory
committee.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
renewal of the Gastrointestinal Drugs
Advisory Committee by the
Commissioner of Food and Drugs (the
Commissioner). The Commissioner has
determined that it is in the public
interest to renew the Gastrointestinal
Drugs Advisory Committee for an
additional 2 years beyond the charter
expiration date. The new charter will be
in effect until March 3, 2020.
DATES: Authority for the Gastrointestinal
Drugs Advisory Committee will expire
on March 3, 2020, unless the
Commissioner formally determines that
renewal is in the public interest.
SUMMARY:
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13136
Federal Register / Vol. 83, No. 59 / Tuesday, March 27, 2018 / Notices
Jay
Fajiculay, Division of Advisory
Committee and Consultant
Management, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, email: GIDAC@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Pursuant
to 41 CFR 102–3.65 and approval by the
Department of Health and Human
Services pursuant to 45 CFR part 11 and
by the General Services Administration,
FDA is announcing the renewal of the
Gastrointestinal Drugs Advisory
Committee (the Committee). The
Committee is a discretionary Federal
advisory committee established to
provide advice to the Commissioner.
The Committee advises the
Commissioner or designee in
discharging responsibilities as they
relate to helping to ensure safe and
effective drugs for human use and, as
required, any other product for which
FDA has regulatory responsibility.
The Committee reviews and evaluates
available data concerning the safety and
effectiveness of marketed and
investigational human drug products for
use in the treatment of gastrointestinal
diseases and makes appropriate
recommendations to the Commissioner
of Food and Drugs.
The Committee shall consist of a core
of 11 voting members including the
Chair. Members and the Chair are
selected by the Commissioner or
designee from among authorities
knowledgeable in the fields of
gastroenterology, endocrinology,
surgery, clinical pharmacology,
physiology, pathology, liver function,
motility, esophagitis, and statistics.
Members will be invited to serve for
overlapping terms of up to 4 years.
Almost all non-Federal members of this
committee serve as Special Government
Employees. The core of voting members
may include one technically qualified
member, selected by the Commissioner
or designee, who is identified with
consumer interests and is recommended
by either a consortium of consumeroriented organizations or other
interested persons. In addition to the
voting members, the Committee may
include one non-voting member who is
identified with industry interests.
Further information regarding the
most recent charter and other
information can be found at https://
www.fda.gov/AdvisoryCommittees/
CommitteesMeetingMaterials/Drugs/
GastrointestinalDrugsAdvisory
Committee/ucm102959.htm or by
contacting the Designated Federal
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FOR FURTHER INFORMATION CONTACT:
VerDate Sep<11>2014
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Jkt 244001
Officer (see FOR FURTHER INFORMATION
In light of the fact that no
change has been made to the committee
name or description of duties, no
amendment will be made to 21 CFR
14.100.
This document is issued under the
Federal Advisory Committee Act (5
U.S.C. app.). For general information
related to FDA advisory committees,
please check https://www.fda.gov/
AdvisoryCommittees/default.htm.
CONTACT).
Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–06063 Filed 3–26–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; NURSE Corps Scholarship
Program; Information Collection
Request Title: Nurse Corps
Scholarship Program, OMB No. 0915–
0301—Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period.
DATES: Comments on this ICR should be
received no later than April 26, 2018.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Nurse Corps Scholarship Program
(NCSP) OMB No. 0915–0301—Revision.
SUMMARY:
PO 00000
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Abstract: The NCSP, administered by
HRSA’s Bureau of Health Workforce,
provides scholarships to nursing
students in exchange for a minimum 2year full-time service commitment (or
part-time equivalent), at an eligible
health care facility with a critical
shortage of nurses (i.e., a Critical
Shortage Facility (CSF)). The
scholarship consists of payment of
tuition, fees, other reasonable
educational costs, and a monthly
support stipend. Program recipients are
required to fulfill NCSP service
commitments at CSFs, which are
located in the 50 States, the District of
Columbia, Guam, the Commonwealth of
Puerto Rico, the Northern Mariana
Islands, the U.S. Virgin Islands,
American Samoa, the Federated States
of Micronesia, the Republic of the
Marshall Islands, and the Republic of
Palau.
Need and Proposed Use of the
Information: The NCSP collects data to
determine an applicant’s eligibility for
the program, monitor a participant’s
continued enrollment in a school of
nursing, monitor the participant’s
compliance with the NCSP service
obligation, and prepare annual reports
to Congress. The following information
will be collected: (1) From the schools,
on a quarterly basis—general applicant
and nursing school data such as full
name, location, tuition/fees, and
enrollment status; (2) from the schools,
on an annual basis—data concerning
tuition/fees and overall student
enrollment status; and (3) from the
participants and their employing CSF
on a biannual basis—data concerning
the participant’s employment status,
work schedule, and leave usage.
The revision to this clearance package
will incorporate one new form and one
updated form. The CSF Verification
Form will be used to verify participant
transfers to CSFs. The Initial
Employment Verification Form has been
revised to include all eligible service
site types listed in the NCSP
Application and Program Guidance.
Likely Respondents: NCSP scholars in
school, graduates, educational
institutions, and CSFs.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
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]]>Agencies
[Federal Register Volume 83, Number 59 (Tuesday, March 27, 2018)]
[Notices]
[Pages 13135-13136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-06063]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-0001]
Advisory Committee; Gastrointestinal Drugs Advisory Committee,
Renewal
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; renewal of advisory committee.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Gastrointestinal Drugs Advisory Committee by the
Commissioner of Food and Drugs (the Commissioner). The Commissioner has
determined that it is in the public interest to renew the
Gastrointestinal Drugs Advisory Committee for an additional 2 years
beyond the charter expiration date. The new charter will be in effect
until March 3, 2020.
DATES: Authority for the Gastrointestinal Drugs Advisory Committee will
expire on March 3, 2020, unless the Commissioner formally determines
that renewal is in the public interest.
[[Page 13136]]
FOR FURTHER INFORMATION CONTACT: Jay Fajiculay, Division of Advisory
Committee and Consultant Management, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
31, Rm. 2417, Silver Spring, MD 20993-0002, 301-796-9001, email:
[email protected].
SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services pursuant to 45 CFR part 11
and by the General Services Administration, FDA is announcing the
renewal of the Gastrointestinal Drugs Advisory Committee (the
Committee). The Committee is a discretionary Federal advisory committee
established to provide advice to the Commissioner.
The Committee advises the Commissioner or designee in discharging
responsibilities as they relate to helping to ensure safe and effective
drugs for human use and, as required, any other product for which FDA
has regulatory responsibility.
The Committee reviews and evaluates available data concerning the
safety and effectiveness of marketed and investigational human drug
products for use in the treatment of gastrointestinal diseases and
makes appropriate recommendations to the Commissioner of Food and
Drugs.
The Committee shall consist of a core of 11 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of gastroenterology, endocrinology, surgery, clinical
pharmacology, physiology, pathology, liver function, motility,
esophagitis, and statistics. Members will be invited to serve for
overlapping terms of up to 4 years. Almost all non-Federal members of
this committee serve as Special Government Employees. The core of
voting members may include one technically qualified member, selected
by the Commissioner or designee, who is identified with consumer
interests and is recommended by either a consortium of consumer-
oriented organizations or other interested persons. In addition to the
voting members, the Committee may include one non-voting member who is
identified with industry interests.
Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/GastrointestinalDrugsAdvisoryCommittee/ucm102959.htm or by contacting
the Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT).
In light of the fact that no change has been made to the committee name
or description of duties, no amendment will be made to 21 CFR 14.100.
This document is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please check https://www.fda.gov/AdvisoryCommittees/default.htm.
Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06063 Filed 3-26-18; 8:45 am]
BILLING CODE 4164-01-P
