Allergenic Products Advisory Committee; Notice of Meeting; Correction, 33078 [2019-14779]
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33078
Federal Register / Vol. 84, No. 133 / Thursday, July 11, 2019 / Notices
jspears on DSK30JT082PROD with NOTICES
The draft guidance provides advice on
how applicants may use the IID to
support the safety of excipients to
facilitate application assessment. Topics
such as referencing the IID for various
excipient grades and ingredients in
colors and flavors are addressed. Since
the IID is referenced in many types of
applications, topics of general concern
to all application types and those
specific to investigational new drug
applications (INDs), new drug
applications (NDAs), and abbreviated
new drug applications (ANDAs) are
described.
Finally, the draft guidance provides
information about where and how to
contact FDA with questions about
excipients and information related to
specific IID listings.
This draft guidance is being issued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The draft guidance, when finalized, will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 current thinking of FDA
on ‘‘Using the Inactive Ingredient
Database.’’ It does not establish any
rights for any person and 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 This draft guidance is
not subject to Executive Order 12866.
II. 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This draft guidance refers to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
(PRA) (44 U.S.C. 3501–3520). The
collection of information in 21 CFR part
314, including the submission of NDAs
and ANDAs, has been approved under
OMB control number 0910–0001. The
collection of information in 21 CFR part
312, including the submission of INDs,
has been approved under OMB control
number 0910–0014. The collection of
information entitled ‘‘Guidance for
Industry on Formal Meetings between
FDA and Sponsors and Applicants for
PDUFA Products’’ has been approved
under OMB control number 0910–0429.
The collection of information entitled
‘‘Controlled Correspondence Related to
Generic Drug Development’’ has been
approved under OMB control number
0910–0797.
In accordance with the PRA, prior to
publication of any final guidance
document, FDA intends to solicit public
comment and obtain OMB approval for
any information collections
recommended in this guidance that are
new or that would represent material
modifications to those previously
VerDate Sep<11>2014
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approved collections of information
found in FDA regulations or guidances.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: July 8, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–14780 Filed 7–10–19; 8:45 am]
BILLING CODE 4164–01–P
Biologics Evaluation and Research
(CBER) Allergenic Products Advisory
Committee (APAC) will meet in open
session to discuss and make
recommendations on the safety and
efficacy of Peanut (Arachis hypogaea)
Allergen Powder manufactured by
Aimmune Therapeutics, Inc., indicated
for treatment to reduce the risk of
anaphylaxis after accidental exposure to
peanut in patients aged 4 to 17 years
with a confirmed diagnosis of peanut
allergy.’’
Dated: July 8, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–14779 Filed 7–10–19; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–2836]
Allergenic Products Advisory
Committee; Notice of Meeting;
Correction
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice; correction.
In the
Federal Register of Monday, June 24,
2019, 84 FR 29524, in FR Doc. 2019–
13354, the following correction is made:
On page 29525, in the first column,
under the headings, SUPPLEMENTARY
INFORMATION and ‘‘Agenda’’, the first
sentence is corrected to read ‘‘On
September 13, 2019, the Center for
PO 00000
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Committee on
Heritable Disorders in Newborns and
Children
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
The Food and Drug
Administration (FDA) is correcting a
notice entitled ‘‘Allergenic Products
Advisory Committee; Notice of
Meeting’’ that appeared in the Federal
Register of June 24, 2019. The document
announced a forthcoming public
advisory committee meeting of the
Allergenic Products Advisory
Committee. The document was
published with the incorrect name of
the committee in the Agenda portion of
the notice. This document corrects that
error.
FOR FURTHER INFORMATION CONTACT:
Capt. Serina Hunter-Thomas or Ms.
Monique Hill, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 6338,
Silver Spring, MD 20993–0002, 240–
402–5771, serina.hunter-thomas@
fda.hhs.gov or 301–796–4620,
monique.hill@fda.hhs.gov, respectively;
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area).
SUMMARY:
SUPPLEMENTARY INFORMATION:
BILLING CODE 4164–01–P
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Advisory
Committee on Heritable Disorders in
Newborns and Children (ACHDNC) has
scheduled a public meeting. Information
about the ACHDNC and the agenda for
this meeting can be found on the
ACHDNC website at https://
www.hrsa.gov/advisory-committees/
heritable-disorders/.
DATES: August 1, 2019, 9:00 a.m.–5:00
p.m. Eastern Time (ET) and August 2,
2019, 9:00 a.m.–3:00 p.m. ET.
ADDRESSES: This meeting will be held in
person and by webcast. The address for
the meeting is 5600 Fishers Lane,
Rockville, Maryland 20857. While this
meeting is open to the public, advance
registration is required. Please visit the
ACHDNC website for information on
registration: https://www.hrsa.gov/
advisory-committees/heritabledisorders/. The deadline for
online registration is 12:00 p.m. ET on
July 29, 2019. Instructions on how to
access the meeting via webcast will be
provided upon registration.
FOR FURTHER INFORMATION CONTACT:
Alaina Harris, Maternal and Child
Health Bureau (MCHB), HRSA, 5600
Fishers Lane, Room 18W66, Rockville,
Maryland 20857; 301–443–0721; or
ACHDNC@hrsa.gov.
SUMMARY:
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]]>Agencies
[Federal Register Volume 84, Number 133 (Thursday, July 11, 2019)]
[Notices]
[Page 33078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-14779]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-N-2836]
Allergenic Products Advisory Committee; Notice of Meeting;
Correction
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; correction.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
entitled ``Allergenic Products Advisory Committee; Notice of Meeting''
that appeared in the Federal Register of June 24, 2019. The document
announced a forthcoming public advisory committee meeting of the
Allergenic Products Advisory Committee. The document was published with
the incorrect name of the committee in the Agenda portion of the
notice. This document corrects that error.
FOR FURTHER INFORMATION CONTACT: Capt. Serina Hunter-Thomas or Ms.
Monique Hill, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6338,
Silver Spring, MD 20993-0002, 240-402-5771, [email protected] or 301-796-4620, [email protected],
respectively; or FDA Advisory Committee Information Line, 1-800-741-
8138 (301-443-0572 in the Washington, DC area).
SUPPLEMENTARY INFORMATION: In the Federal Register of Monday, June 24,
2019, 84 FR 29524, in FR Doc. 2019-13354, the following correction is
made:
On page 29525, in the first column, under the headings,
SUPPLEMENTARY INFORMATION and ``Agenda'', the first sentence is
corrected to read ``On September 13, 2019, the Center for Biologics
Evaluation and Research (CBER) Allergenic Products Advisory Committee
(APAC) will meet in open session to discuss and make recommendations on
the safety and efficacy of Peanut (Arachis hypogaea) Allergen Powder
manufactured by Aimmune Therapeutics, Inc., indicated for treatment to
reduce the risk of anaphylaxis after accidental exposure to peanut in
patients aged 4 to 17 years with a confirmed diagnosis of peanut
allergy.''
Dated: July 8, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-14779 Filed 7-10-19; 8:45 am]
BILLING CODE 4164-01-P
