Insanitary Conditions at Compounding Facilities; Draft Guidance for Industry; Availability, 51449-51450 [2016-18461]
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Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[CFDA Number: 93.623]
Announcement of the Intent to Award
a Supplemental Grant to the National
Safe Place Network in Louisville, KY
Family and Youth Services
Bureau, ACYF, ACF, HHS.
ACTION: Notice.
AGENCY:
The Administration for
Children and Families (ACF),
Administration on Children, Youth and
Families (ACYF), Family and Youth
Services Bureau (FYSB) announces its
intent to award a non-competitive
supplemental grant in the amount of up
to $310,000 to the National Safe Place
Network in Louisville, KY, to support
and expand the grantee’s activities
under their award for the Runaway and
Homeless Youth Training and Technical
Assistance Center (RHYTTAC).
DATES: The proposed supplement is
intended to support costs for the period
of September 30, 2016, through
September 29, 2017.
FOR FURTHER INFORMATION CONTACT: Ana
Cody, Family and Youth Services
Bureau, 330 C Street SW., Washington,
DC 20024. Telephone: 202–205–8418
Email: Ana.Cody@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: The
National Safe Place Network is the
recipient agency of the RHYTTAC
cooperative agreement that fulfills
Section 342 of the Runaway and
Homeless Youth (RHY) Act, which
allows for grants to organizations to
provide training and technical
assistance to public and private entities
that are eligible to receive grants under
this title. The purpose of this agreement
is for carrying out the programs,
projects, or activities for which such
grants are made. The original award was
made as the result of a competition
under ACF Funding Opportunity
Announcement HHS–2012–ACF–
ACYF–CY–0312.
The primary goal of the RHYTTAC
program is to serve as a centralized,
national Training and Technical
Assistance (T&TA) resource for FYSBfunded RHY program grantees. Training
and other resources are made available
to assist grantees to improve the quality
of their core services, build capacity to
increase the number of youth served,
and address the dynamic needs of the
runaway and homeless youth
population.
The total supplemental funding
available for the proposed non-
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SUMMARY:
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competitive award would allow for the
allocation of $150,000 for T&TA to
support 12 new Domestic Victims of
Human Trafficking (DVHT) grantees and
the allocation of $160,000 for T&TA to
support 8 new Transitional Living
Program (TLP) demonstration program
grantees.
The supplemental funding will be
used to provide each grantee in the
DVHT program with an on-site T&TA
visit by RHYTTAC to collect
information from a Human Trafficking
Specific Capacity Assessment. The
assessment and on-site observations will
be used to create individualized action
plans for each grantee to direct
RHYTTAC’s work with them for the
remainder of their projects. In addition,
RHYTTAC will facilitate discussions
with human trafficking experts and
coordinate a peer-exchange meeting to
encourage grantees to build a cohesive
working group. It will operate as a unit
to ensure that all programs are
functioning from the same baseline
performance level. The proposed
funding also will support new
approaches and strategies to better serve
Lesbian, Gay, Bisexual, Transgender,
and Questioning (LGBTQ) youth and
youth who are ‘‘aging out’’ of foster care.
A new, non-competitive application
will be solicited from the National Safe
Place Network. The application will
receive an objective review by a panel
using criteria related to the program’s
approach, objectives, outcomes and
need for assistance, organizational
profile, and an assessment of the
proposed budget and budget
justification.
STATUTORY AUTHORITY: The RHY and
FYSB grantee is authorized by the RHY
Act, 42 U.S.C. 5701–5752, as most
recently amended by the Reconnecting
Homeless Youth Act of 2008, Pub.
L.110–378, on October 8, 2008.
Mary M. Wayland,
Senior Grants Policy Specialist, Division of
Grants Policy, Office of Administration,
Administration for Children and Families.
[FR Doc. 2016–18502 Filed 8–3–16; 8:45 am]
BILLING CODE 4182–04–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–D–2268]
Insanitary Conditions at Compounding
Facilities; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
ACTION:
51449
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Insanitary Conditions
at Compounding Facilities.’’ Drug
products compounded under insanitary
conditions could become contaminated
and cause serious adverse events in
patients, including death. FDA is
issuing this draft guidance to assist
compounding facilities in identifying
insanitary conditions so that they can
implement appropriate corrective
actions, and to assist State regulatory
agencies in understanding some
examples of what FDA considers to be
insanitary conditions.
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 October 3,
2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
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): Division of
Dockets Management (HFA–305), Food
E:\FR\FM\04AUN1.SGM
04AUN1
sradovich on DSK3GMQ082PROD with NOTICES
51450
Federal Register / Vol. 81, No. 150 / Thursday, August 4, 2016 / Notices
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2016–D–2268 for ‘‘Insanitary Conditions
at Compounding Facilities.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
VerDate Sep<11>2014
18:12 Aug 03, 2016
Jkt 238001
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–
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.
FOR FURTHER INFORMATION CONTACT: Sara
Rothman, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 5197, Silver Spring,
MD 20993, 301–796–3110.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Insanitary Conditions at Compounding
Facilities.’’ Under section 501(a)(2)(A)
of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C.
351(a)(2)(A)), a drug is deemed to be
adulterated if it has been prepared,
packed, or held under insanitary
conditions whereby it may have been
contaminated with filth, or whereby it
may have been rendered injurious to
health. Drug products compounded
under insanitary conditions could
become contaminated and cause serious
adverse events in patients, including
death. Although sections 503A and
503B of the FD&C Act (21 U.S.C. 353a
and 353b) provide exemptions for
compounded drugs from specified
provisions of the FD&C Act if certain
conditions are met, neither section
provides an exemption from section
501(a)(2)(A) of the FD&C Act. Any drug
that is prepared, packed, or held under
insanitary conditions is deemed to be
adulterated under the FD&C Act,
including drugs produced by a
compounding facility.
Since the 2012 fungal meningitis
outbreak associated with injectable drug
products that a compounding facility
produced and shipped across the
country, FDA has identified insanitary
conditions at many of the compounding
facilities that it has inspected, and
numerous compounding facilities have
voluntarily recalled drug products
intended to be sterile and temporarily or
permanently ceased sterile operations as
a result of these findings. However, FDA
does not inspect the vast majority of
compounding facilities in the United
States because they generally do not
register with FDA unless they elect to
become outsourcing facilities.
Therefore, FDA is often not aware of
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
these facilities and potential problems
with their drug products, or conditions
and practices, unless it receives a
complaint such as a report of a serious
adverse event or visible contamination.
It is critical that compounding facilities
avoid the presence of insanitary
conditions and identify and remediate
any insanitary conditions at their
facilities before the conditions result in
drug contamination and patient injury.
FDA is issuing this draft guidance to
assist compounding facilities in
identifying insanitary conditions so that
they can implement appropriate
corrective actions, and to assist State
regulatory agencies in understanding
some examples of what FDA considers
to be insanitary conditions.
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 insanitary conditions at
compounding facilities. 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.
II. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: July 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–18461 Filed 8–3–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–0544]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; National Direct-toConsumer Advertising Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
SUMMARY:
E:\FR\FM\04AUN1.SGM
04AUN1
Agencies
[Federal Register Volume 81, Number 150 (Thursday, August 4, 2016)]
[Notices]
[Pages 51449-51450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-18461]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-D-2268]
Insanitary Conditions at Compounding Facilities; 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 ``Insanitary
Conditions at Compounding Facilities.'' Drug products compounded under
insanitary conditions could become contaminated and cause serious
adverse events in patients, including death. FDA is issuing this draft
guidance to assist compounding facilities in identifying insanitary
conditions so that they can implement appropriate corrective actions,
and to assist State regulatory agencies in understanding some examples
of what FDA considers to be insanitary conditions.
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 October 3, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you 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): Division of Dockets Management (HFA-305), Food
[[Page 51450]]
and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD
20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2016-D-2268 for ``Insanitary Conditions at Compounding
Facilities.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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 20993-0002. 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.
FOR FURTHER INFORMATION CONTACT: Sara Rothman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 5197, Silver Spring, MD 20993, 301-796-
3110.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Insanitary Conditions at Compounding Facilities.'' Under
section 501(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) (21 U.S.C. 351(a)(2)(A)), a drug is deemed to be adulterated
if it has been prepared, packed, or held under insanitary conditions
whereby it may have been contaminated with filth, or whereby it may
have been rendered injurious to health. Drug products compounded under
insanitary conditions could become contaminated and cause serious
adverse events in patients, including death. Although sections 503A and
503B of the FD&C Act (21 U.S.C. 353a and 353b) provide exemptions for
compounded drugs from specified provisions of the FD&C Act if certain
conditions are met, neither section provides an exemption from section
501(a)(2)(A) of the FD&C Act. Any drug that is prepared, packed, or
held under insanitary conditions is deemed to be adulterated under the
FD&C Act, including drugs produced by a compounding facility.
Since the 2012 fungal meningitis outbreak associated with
injectable drug products that a compounding facility produced and
shipped across the country, FDA has identified insanitary conditions at
many of the compounding facilities that it has inspected, and numerous
compounding facilities have voluntarily recalled drug products intended
to be sterile and temporarily or permanently ceased sterile operations
as a result of these findings. However, FDA does not inspect the vast
majority of compounding facilities in the United States because they
generally do not register with FDA unless they elect to become
outsourcing facilities. Therefore, FDA is often not aware of these
facilities and potential problems with their drug products, or
conditions and practices, unless it receives a complaint such as a
report of a serious adverse event or visible contamination. It is
critical that compounding facilities avoid the presence of insanitary
conditions and identify and remediate any insanitary conditions at
their facilities before the conditions result in drug contamination and
patient injury.
FDA is issuing this draft guidance to assist compounding facilities
in identifying insanitary conditions so that they can implement
appropriate corrective actions, and to assist State regulatory agencies
in understanding some examples of what FDA considers to be insanitary
conditions.
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 insanitary
conditions at compounding facilities. 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.
II. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
Dated: July 29, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-18461 Filed 8-3-16; 8:45 am]
BILLING CODE 4164-01-P