Agency Information Collection Activities: Proposed Collection; Comment Request; Guidance for Industry on Registration of Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act, 28076-28078 [2017-12838]
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28076
Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
the United States Code authorize
Federal agencies to rate applicants for
Federal jobs. The proposed information
collection involves brief online
applications completed by applicants
applying to FDA’s fellowship programs.
These voluntary online applications
will allow the Agency to easily and
efficiently elicit and review information
from students and healthcare
professionals who are interested in
becoming involved in FDA-wide
activities. The process will reduce the
time and cost of submitting written
documentation to the Agency and lessen
the likelihood of applications being
misrouted within the Agency mail
system. It will assist the Agency in
promoting and protecting the public
health by encouraging outside persons
to share their expertise with FDA.
FDA estimates the burden of this
collection of information as follows:
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Application for Participation in FDA
Fellowship Programs (Formerly
Application for Participation in the
FDA Commissioner’s Fellowship
Program)
OMB Control Number 0910–0780—
Extension
Sections 1104, 1302, 3301, 3304,
3320, 3361, 3393, and 3394 of Title 5 of
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
respondents
Activity
Number of
responses
per
respondent
Total
annual
responses
Average
burden per
response
Total hours
Commissioner’s Fellowship Program ..................................
Regulatory Science Internship Program ..............................
Medical Device Fellowship Program ...................................
600
250
250
1
1
1
600
250
250
1.33
1
1
798
250
250
Total ..............................................................................
........................
........................
........................
........................
1,298
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12781 Filed 6–19–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
sradovich on DSK3GMQ082PROD with NOTICES
[Docket No. FDA–2013–N–1429]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; Guidance for
Industry on Registration of Human
Drug Compounding Outsourcing
Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
VerDate Sep<11>2014
18:01 Jun 19, 2017
Jkt 241001
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection in the guidance on
registration of human drug
compounding outsourcing facilities
under the Federal Food, Drug, and
Cosmetic Act (the FD&C Act).
DATES: Submit either electronic or
written comments on the collection of
information by August 21, 2017.
ADDRESSES: You may submit comments
as follows. Please note that late,
SUMMARY:
PO 00000
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Fmt 4703
Sfmt 4703
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 21,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of August 21, 2017.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
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
E:\FR\FM\20JNN1.SGM
20JNN1
Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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): 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–
2013–N 1429 for ‘‘Guidance for Industry
on Registration of Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff 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
VerDate Sep<11>2014
18:01 Jun 19, 2017
Jkt 241001
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. 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.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.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North 10A63, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
PO 00000
Frm 00035
Fmt 4703
Sfmt 4703
28077
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Guidance for Industry on Registration
of Human Drug Compounding
Outsourcing Facilities Under Section
503B of the Federal Food, Drug, and
Cosmetic Act: OMB Control Number
0910–0777—Extension
A facility that compounds drugs may
elect to register with FDA as an
outsourcing facility under section 503B
of the FD&C Act (21 U.S.C. 353b), as
added by the Drug Quality and Security
Act (DQSA). Drug products
compounded in a registered outsourcing
facility can qualify for exemptions from
the FDA approval requirements in
section 505 of the FD&C Act (21 U.S.C.
355), the requirement to label products
with adequate directions for use under
section 502(f)(1) of the FD&C Act (21
U.S.C. 352(f)(1)), and drug supply chain
security requirements in section 582 of
the FD&C Act (21 U.S.C. 360eee) if the
requirements in section 503B are met.
After the initial registration, under
section 503B(b) of the FD&C Act, a
facility that elects to register with FDA
as an outsourcing facility must also do
so annually between October 1 and
December 31. Upon registration, the
outsourcing facility must provide its
name, place of business, a unique
facility identifier, and a point of contact
email address. The outsourcing facility
must also indicate whether it intends to
compound, within the next calendar
year, a drug that appears on FDA’s drug
shortage list in effect under section 506E
of the FD&C Act (21 U.S.C. 356e), and
whether it compounds from bulk drug
substances, and, if so, whether it
compounds sterile or non-sterile drugs
from bulk drug substances.
Outsourcing facilities that elect to
register should submit the following
registration information to FDA for each
facility:
• Name of the facility;
• Place of business;
• Unique facility identifier;
• Point of contact email address and
phone number;
• Whether the facility intends to
compound drugs that appear on FDA’s
drug shortage list in effect under section
506E of the FD&C Act; and
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Federal Register / Vol. 82, No. 117 / Tuesday, June 20, 2017 / Notices
• An indication of whether the
facility compounds from bulk drug
substances, and if so, whether it
compounds sterile or nonsterile drugs
from bulk drug substances.
Registration information should be
submitted to FDA electronically using
the Structured Product Labeling (SPL)
format and in accordance with section
IV of the FDA guidance entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Drug Establishment
Registration and Drug Listing.’’ Under
the final guidance, outsourcing facilities
may request a waiver from the SPL
electronic submission process by
submitting a written request to FDA
explaining why the use of electronic
means is not reasonable.
This information collection supports
the Agency guidance discussed above.
We estimate that approximately 62
outsourcing facilities (‘‘number of
respondents’’ and ‘‘total annual
responses’’ in table 1, row 1) will
annually submit to FDA registration
information using the SPL format as
specified in the guidance, and that
preparing and submitting this
information will take approximately 4.5
hours per registrant (‘‘average burden
per response’’ in table 1, row 1). We
expect to receive no more than one
waiver request from the electronic
submission process annually (‘‘number
of respondents’’ and ‘‘total annual
responses’’ in table 1, row 2), and that
each request should take approximately
1 hour to prepare and submit to us
(‘‘average burden per response’’ in table
1, row 2).
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Compounding
outsourcing
facility
Electronic Submission of Registration Information Using
SPL Format ......................................................................
Waiver Request From Electronic Submission of Registration Information .................................................................
Total ..............................................................................
1 There
[FR Doc. 2017–12838 Filed 6–19–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
Notice is hereby given that
the Office of Research Integrity (ORI)
has taken final action in the following
case:
Brandi M. Baughman, Ph.D., National
Institutes of Health (NIH): Based on
Respondent’s admission and analysis
conducted by ORI, ORI found that Dr.
Brandi M. Baughman, former Intramural
Research Training Awardee, National
Institute of Environmental and Health
Sciences (NIEHS), NIH, engaged in
research misconduct in research
supported by National Institute of
Diabetes and Digestive and Kidney
Diseases (NIDDK), NIH, grant R01
DK101645 and the NIEHS, NIH,
Postdoctoral Intramural Research
Training Award (IRTA).
ORI found that falsified and/or
fabricated data were included in eleven
SUMMARY:
sradovich on DSK3GMQ082PROD with NOTICES
Average
burden per
response
Total annual
responses
Total hours
62
1
62
4.5
279
1
1
1
1
1
........................
........................
........................
........................
280
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning
Legislation, and Analysis.
ACTION:
Number of
responses
per
respondent
Number of
respondents
VerDate Sep<11>2014
18:01 Jun 19, 2017
Jkt 241001
(11) figures in PLoS One
11(10):e0164378, 2016 (hereafter
referred to as ‘‘PLoS One 2016’’).
ORI found that Respondent falsified
and/or fabricated data and text
published in PLoS One 2016, in Figures
2, 3, 4, 5, 6, 8, S1, S2, S3, S4, and S5,
by claiming that a screening strategy of
the kinase focused libraries, PKIS and
5K, was performed, when original data
do not exist to support the claims.
Respondent also claimed that three (3)
inhibitory compounds for the inositol
phosphate kinase, PPIP5K, were
identified from the 5K library, when
these compounds, UNC10112646,
UNC10225354, and UNC10225498, were
not part of the data set for the 5K
library. Specifically, Respondent
falsified and/or fabricated the
characterization of the inhibitor
compounds in:
• Figures 2 and 3 results for Z’-factor,
%CV, signal:background ratio, and a 10point dose response titration experiment
for inhibitor UNC10225354
• claims in the text of PLoS One 2016
that eight molecules from the PKIS
library and fifteen molecules from the
5K library inhibited PPIP5K activity by
>50%
• Figure 4D results for the inhibition
by UNC10112646, UNC10225354, and
UNC10225498, in dose response assays
against the kinase domain of PPIP5K
• Figures 5A and 5B results for
isothermal titration calorimetry (ITC)
assays for quantifying intermolecular
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
interactions between PPIP5K and the
inhibitors, UNC1011264 and
UNC10225498, and Figure S5 for
UNC10225354
• Figure 6 results for the analysis of
the mechanisms of inhibition of PPIP5K
by UNC10112646 and UNC10225498
• Figures 8A and 8B results for high
performance liquid chromatography
(HPLC) analysis for the effects of
UNC10112646 or UNC10225498 on
PPIP5K activity and IP6K activity
• Figures S1–S4 for experimental
results further characterizing
UNC10112646, UNC10225498, and
other inhibitors, when the results were
not supported by the experimental
records.
As a result of Respondent’s
admission, NIH recommended that the
PLoS One 2016 paper be retracted.
Dr. Baughman has entered into a
Voluntary Settlement Agreement with
ORI, in which she voluntarily agreed:
(1) To have her research supervised
for a period of three (3) years beginning
on May 17, 2017; Respondent agreed to
ensure that prior to the submission of an
application for U.S. Public Health
Service (PHS) support for a research
project on which Respondent’s
participation is proposed and prior to
Respondent’s participation in any
capacity on PHS-supported research,
Respondent shall ensure that a plan for
supervision of Respondent’s duties is
submitted to ORI for approval; the
supervision plan must be designed to
E:\FR\FM\20JNN1.SGM
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]]>Agencies
[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)]
[Notices]
[Pages 28076-28078]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12838]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1429]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Guidance for Industry on Registration of Human Drug
Compounding Outsourcing Facilities Under Section 503B of the Federal
Food, Drug, and Cosmetic Act
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection in the guidance
on registration of human drug compounding outsourcing facilities under
the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
DATES: Submit either electronic or written comments on the collection
of information by August 21, 2017.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 21, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 21, 2017. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
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
[[Page 28077]]
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): 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-2013-N 1429 for ``Guidance for Industry on Registration of Human
Drug Compounding Outsourcing Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff 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 Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.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.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Guidance for Industry on Registration of Human Drug Compounding
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act: OMB Control Number 0910-0777--Extension
A facility that compounds drugs may elect to register with FDA as
an outsourcing facility under section 503B of the FD&C Act (21 U.S.C.
353b), as added by the Drug Quality and Security Act (DQSA). Drug
products compounded in a registered outsourcing facility can qualify
for exemptions from the FDA approval requirements in section 505 of the
FD&C Act (21 U.S.C. 355), the requirement to label products with
adequate directions for use under section 502(f)(1) of the FD&C Act (21
U.S.C. 352(f)(1)), and drug supply chain security requirements in
section 582 of the FD&C Act (21 U.S.C. 360eee) if the requirements in
section 503B are met.
After the initial registration, under section 503B(b) of the FD&C
Act, a facility that elects to register with FDA as an outsourcing
facility must also do so annually between October 1 and December 31.
Upon registration, the outsourcing facility must provide its name,
place of business, a unique facility identifier, and a point of contact
email address. The outsourcing facility must also indicate whether it
intends to compound, within the next calendar year, a drug that appears
on FDA's drug shortage list in effect under section 506E of the FD&C
Act (21 U.S.C. 356e), and whether it compounds from bulk drug
substances, and, if so, whether it compounds sterile or non-sterile
drugs from bulk drug substances.
Outsourcing facilities that elect to register should submit the
following registration information to FDA for each facility:
Name of the facility;
Place of business;
Unique facility identifier;
Point of contact email address and phone number;
Whether the facility intends to compound drugs that appear
on FDA's drug shortage list in effect under section 506E of the FD&C
Act; and
[[Page 28078]]
An indication of whether the facility compounds from bulk
drug substances, and if so, whether it compounds sterile or nonsterile
drugs from bulk drug substances.
Registration information should be submitted to FDA electronically
using the Structured Product Labeling (SPL) format and in accordance
with section IV of the FDA guidance entitled ``Providing Regulatory
Submissions in Electronic Format--Drug Establishment Registration and
Drug Listing.'' Under the final guidance, outsourcing facilities may
request a waiver from the SPL electronic submission process by
submitting a written request to FDA explaining why the use of
electronic means is not reasonable.
This information collection supports the Agency guidance discussed
above. We estimate that approximately 62 outsourcing facilities
(``number of respondents'' and ``total annual responses'' in table 1,
row 1) will annually submit to FDA registration information using the
SPL format as specified in the guidance, and that preparing and
submitting this information will take approximately 4.5 hours per
registrant (``average burden per response'' in table 1, row 1). We
expect to receive no more than one waiver request from the electronic
submission process annually (``number of respondents'' and ``total
annual responses'' in table 1, row 2), and that each request should
take approximately 1 hour to prepare and submit to us (``average burden
per response'' in table 1, row 2).
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average
Compounding outsourcing Number of responses per Total annual burden per Total hours
facility respondents respondent responses response
----------------------------------------------------------------------------------------------------------------
Electronic Submission of 62 1 62 4.5 279
Registration Information Using
SPL Format.....................
Waiver Request From Electronic 1 1 1 1 1
Submission of Registration
Information....................
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Total....................... .............. .............. .............. .............. 280
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Dated: June 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning Legislation, and Analysis.
[FR Doc. 2017-12838 Filed 6-19-17; 8:45 am]
BILLING CODE 4164-01-P
