Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act, 27493-27496 [2017-12353]
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Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
drug and biological products and related
materials, including, but not limited to,
social and behavioral research,
decisionmaking processes, and
communication and behavioral change
strategies.
Annually, FDA estimates about 45
social and behavioral studies using the
variety of test methods listed in this
document. FDA is requesting this
burden so as not to restrict the Agency’s
ability to gather information on public
sentiment for its proposals in its
regulatory and communications
programs.
In the Federal Register of September
19, 2016 (81 FR 64166), FDA published
a 60-day notice requesting public
27493
comment on the proposed extension of
this collection of information. No
comments were received in response to
the notice.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Interviews/Surveys .....................................................
1 There
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0329]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Guidance for
Industry on Fees for Human Drug
Compounding Outsourcing Facilities
Under the Federal Food, Drug, and
Cosmetic Act
Food and Drug Administration,
HHS.
Notice.
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 Fees for
Human Drug Compounding Outsourcing
Facilities Under the Federal Food, Drug,
and Cosmetic Act (FD&C Act).
DATES: Submit either electronic or
written comments on the collection of
information by August 14, 2017.
SUMMARY:
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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 14,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of August 14, 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.
ADDRESSES:
[FR Doc. 2017–12446 Filed 6–14–17; 8:45 am]
ACTION:
2,520
Average
burden per
response
Total annual
responses
36,792
0.25 (15 minutes) ....
Total hours
9,198
are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: June 12, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
AGENCY:
Number of
responses per
respondent
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’’).
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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
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–
2014–D–0329 for ‘‘Guidance for
Industry on Fees for Human Drug
Compounding Outsourcing Facilities
Under Sections 503B and 744K 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
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
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pmangrum on DSK3GDR082PROD with NOTICES
27494
Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
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.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 Division of Dockets
Management, 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
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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 Fees for
Human Drug Compounding
Outsourcing Facilities Under Sections
503B and 744K of the FD&C Act—OMB
Control Number 0910–0776—Extension
On November 27, 2013, the President
signed the Drug Quality and Security
Act (DQSA) (Pub. L. 113–54) into law.
The DQSA added a new section, 503B
(21 U.S.C. 353B), to the FD&C Act,
creating a category of entities called
‘‘outsourcing facilities.’’ Outsourcing
facilities, as defined in section
503B(d)(4) of the FD&C Act, are
facilities that meet certain requirements
described in section 503B, including
registering with FDA as an outsourcing
facility and paying associated fees. Drug
products compounded in an
outsourcing facility can qualify for
exemptions from the FDA approval
requirements in section 505 of the FD&C
Act (21 U.S.C. 355) and 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)) if the requirements in section
503B of the FD&C Act are met.
The guidance is intended for entities
that compound human drugs and elect
to register as outsourcing facilities
under section 503B of the FD&C Act.
Once an entity has elected to register as
an outsourcing facility, it must pay
certain fees to be registered as an
outsourcing facility. The guidance
describes the types and amounts of fees
that outsourcing facilities must pay, the
adjustments to fees required by law, the
way in which outsourcing facilities may
submit payment to FDA, the
consequences of outsourcing facilities’
failure to pay fees, and the way an
outsourcing facility may qualify as a
small business to obtain a reduction in
fees.
The guidance contains the following
collections of information.
As described in section III.A of the
guidance, upon receiving registration
information from a facility seeking to
register as an outsourcing facility, FDA
will send an invoice for an
establishment fee to the outsourcing
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facility. The invoice contains
instructions for paying the
establishment fee, as discussed in
section III.E of the guidance. This
process would be repeated annually
under the timeframes described in the
guidance. An outsourcing facility is not
considered registered until the required
establishment fee is paid for that fiscal
year.
We estimate that annually a total of 60
outsourcing facilities (‘‘number of
respondents’’ in table 1, row 1) will pay
to FDA 60 establishment fees (‘‘total
annual responses’’ in table 1, row 1) as
described in the guidance. We also
estimate that it will take an outsourcing
facility 0.5 hour to prepare and submit
to FDA each establishment fee (‘‘average
burden per response’’ in table 1, row 1).
As described in section III.C of the
guidance, outsourcing facilities that are
re-inspected will be assessed a reinspection fee for each re-inspection.
The re-inspection fee is designed to
reimburse FDA when it must visit a
particular outsourcing facility more than
once because of noncompliance
identified during a previous inspection.
A re-inspection fee will be incurred for
each re-inspection that occurs. After
FDA conducts a re-inspection, we will
send an invoice to the email address
indicated in the facility’s registration
file. The invoice contains instructions
for paying the re-inspection fee, as
discussed in section III.E of the
guidance.
We estimate that annually a total of 15
outsourcing facilities (‘‘number of
respondents’’ in table 2, row 1) will pay
to FDA 15 re-inspection fees (‘‘total
annual responses’’ in table 2, row 1) as
described in the guidance. We also
estimate that it will take an outsourcing
facility 0.5 hour to prepare and submit
to FDA each re-inspection fee (‘‘average
burden per response’’ in table 2, row 1).
As described in section III.D of the
guidance, certain outsourcing facilities
may qualify for a small business
reduction in the amount of the annual
establishment fee. To qualify for this
reduction, an outsourcing facility must
submit to FDA a written request
certifying that the entity meets the
requirements for the reduction. For
every fiscal year that the firm seeks to
qualify as a small business and receive
the fee reduction, the written request
must be submitted to FDA by April 30
of the preceding fiscal year. For
example, an outsourcing facility must
submit a written request for the small
business reduction by April 30, 2015, to
qualify for a reduction in the fiscal year
2016 annual establishment fee. As
described in the guidance, section 744K
of the FD&C Act (21 U.S.C. 379j–62) also
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Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
requires an outsourcing facility to
submit its written request for a small
business reduction in a format specified
by FDA in the guidance. The guidance
specifies that Form FDA 3908 is the
format for submitting requests for a
small business fee reduction.
We estimate that annually a total of 15
outsourcing facilities (‘‘number of
respondents’’ in table 1, row 2) will
submit to FDA a request for a small
business reduction in the amount of the
annual establishment fee. We estimate
that 15 outsourcing facilities will submit
Form FDA 3908 (‘‘total annual
responses’’ in table 1, row 2) to FDA
annually, as described in the guidance,
and that it will take an outsourcing
facility 25 hours to prepare and submit
to FDA each Form FDA 3908 (‘‘average
burden per response’’ in table 1, row 2).
As described in section III.D of the
guidance, those outsourcing facilities
that request a small business reduction
in the amount of the annual
establishment fee will receive a small
business designation letter notifying the
facility of FDA’s decision. Outsourcing
facilities eligible to pay a reduced fee
should maintain a copy of the small
business designation letter applicable to
that fiscal year for their records.
We estimate that annually a total of 15
outsourcing facilities (‘‘number of
recordkeepers’’ in table 3) will keep a
copy of their small business designation
letter (‘‘total annual records’’ in table 3),
and that maintaining each record will
take 0.5 hour (‘‘average burden per
recordkeeping’’ in table 3).
As described in section V.B of the
guidance, an outsourcing facility may
request reconsideration under 21 CFR
10.75 of an FDA decision related to the
fee provisions of section 744K of the
FD&C Act. As explained in the
guidance, the request should state the
facility’s rationale for its position that
the decision was in error and include
any additional information that is
relevant to the outsourcing facility’s
argument.
We estimate that a total of three
outsourcing facilities (‘‘number of
27495
respondents’’ in table 2, row 2) annually
will submit to FDA a request for
reconsideration as described in the
guidance. We estimate that it will take
an outsourcing facility approximately 1
hour to prepare and submit to FDA each
request for reconsideration (‘‘average
burden per response’’ in table 2, row 2).
As described in section V.B of the
guidance, an outsourcing facility may
appeal, as set forth in § 10.75, an FDA
denial of a request for reconsideration of
an FDA decision related to the fee
provisions of section 744K of the FD&C
Act.
We estimate that a total of one
outsourcing facility (‘‘number of
respondents’’ in table 2, row 3) annually
will submit an appeal of an FDA denial
of a request for reconsideration. We
estimate that it will take an outsourcing
facility 1 hour to prepare and submit
each appeal under § 10.75 (‘‘average
burden per response’’ in table 2, row 3).
The estimated reporting and
recordkeeping burdens for this
collection of information are as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—ESTABLISHMENT FEE 1
Number of
respondents
Type of reporting
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Payment of annual establishment fee .....................
Request for Small Business Establishment Fee
Reduction (FDA Form 3908).
60
15
1
1
60
15
.5 (30 minutes) ..........
25 ..............................
30
375
Total ..................................................................
........................
........................
........................
....................................
405
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN—RE-INSPECTION FEE AND DISPUTE RESOLUTION REQUESTS 1
Number of
respondents
Type of reporting
Number of
responses per
respondent
Total annual
responses
Average burden
per response
Total hours
Payment of re-inspection fee ...................................
Reconsideration request ..........................................
Appeal request .........................................................
15
3
1
1
1
1
15
3
1
.5 (30 minutes) ..........
1 ................................
1 ................................
7.50
3
1
Total ..................................................................
........................
........................
........................
....................................
11.50
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 3—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
Type of recordkeeping
Copy of small business designation letter ...............
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1 There
Number of
records per
recordkeeper
15
1
Total annual
records
15
Average burden
per record
.5 (30 minutes) ..........
are no capital costs or operating and maintenance costs associated with this collection of information.
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Total hours
7.50
27496
Federal Register / Vol. 82, No. 114 / Thursday, June 15, 2017 / Notices
Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–12353 Filed 6–14–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–E–0118]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; NATPARA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
NATPARA and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of an
application to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of a patent which claims that
human biological product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by August 14, 2017.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
December 12, 2017. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
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 14,
2017. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of August 14, 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.
pmangrum on DSK3GDR082PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
VerDate Sep<11>2014
14:10 Jun 14, 2017
Jkt 241001
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
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–E–0118 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; NATPARA.’’
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
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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.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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
(301) 796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological product becomes effective
and runs until the approval phase
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Agencies
[Federal Register Volume 82, Number 114 (Thursday, June 15, 2017)]
[Notices]
[Pages 27493-27496]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-12353]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0329]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Guidance for Industry on Fees for Human Drug
Compounding Outsourcing Facilities Under 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 Fees for Human Drug Compounding Outsourcing Facilities Under the
Federal Food, Drug, and Cosmetic Act (FD&C Act).
DATES: Submit either electronic or written comments on the collection
of information by August 14, 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 14, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of August 14, 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 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 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-2014-D-0329 for ``Guidance for Industry on Fees for Human Drug
Compounding Outsourcing Facilities Under Sections 503B and 744K 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 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
[[Page 27494]]
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.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 Division of Dockets Management, 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 Fees for Human Drug Compounding Outsourcing
Facilities Under Sections 503B and 744K of the FD&C Act--OMB Control
Number 0910-0776--Extension
On November 27, 2013, the President signed the Drug Quality and
Security Act (DQSA) (Pub. L. 113-54) into law. The DQSA added a new
section, 503B (21 U.S.C. 353B), to the FD&C Act, creating a category of
entities called ``outsourcing facilities.'' Outsourcing facilities, as
defined in section 503B(d)(4) of the FD&C Act, are facilities that meet
certain requirements described in section 503B, including registering
with FDA as an outsourcing facility and paying associated fees. Drug
products compounded in an outsourcing facility can qualify for
exemptions from the FDA approval requirements in section 505 of the
FD&C Act (21 U.S.C. 355) and 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)) if the requirements in section 503B of the FD&C Act
are met.
The guidance is intended for entities that compound human drugs and
elect to register as outsourcing facilities under section 503B of the
FD&C Act. Once an entity has elected to register as an outsourcing
facility, it must pay certain fees to be registered as an outsourcing
facility. The guidance describes the types and amounts of fees that
outsourcing facilities must pay, the adjustments to fees required by
law, the way in which outsourcing facilities may submit payment to FDA,
the consequences of outsourcing facilities' failure to pay fees, and
the way an outsourcing facility may qualify as a small business to
obtain a reduction in fees.
The guidance contains the following collections of information.
As described in section III.A of the guidance, upon receiving
registration information from a facility seeking to register as an
outsourcing facility, FDA will send an invoice for an establishment fee
to the outsourcing facility. The invoice contains instructions for
paying the establishment fee, as discussed in section III.E of the
guidance. This process would be repeated annually under the timeframes
described in the guidance. An outsourcing facility is not considered
registered until the required establishment fee is paid for that fiscal
year.
We estimate that annually a total of 60 outsourcing facilities
(``number of respondents'' in table 1, row 1) will pay to FDA 60
establishment fees (``total annual responses'' in table 1, row 1) as
described in the guidance. We also estimate that it will take an
outsourcing facility 0.5 hour to prepare and submit to FDA each
establishment fee (``average burden per response'' in table 1, row 1).
As described in section III.C of the guidance, outsourcing
facilities that are re-inspected will be assessed a re-inspection fee
for each re-inspection. The re-inspection fee is designed to reimburse
FDA when it must visit a particular outsourcing facility more than once
because of noncompliance identified during a previous inspection. A re-
inspection fee will be incurred for each re-inspection that occurs.
After FDA conducts a re-inspection, we will send an invoice to the
email address indicated in the facility's registration file. The
invoice contains instructions for paying the re-inspection fee, as
discussed in section III.E of the guidance.
We estimate that annually a total of 15 outsourcing facilities
(``number of respondents'' in table 2, row 1) will pay to FDA 15 re-
inspection fees (``total annual responses'' in table 2, row 1) as
described in the guidance. We also estimate that it will take an
outsourcing facility 0.5 hour to prepare and submit to FDA each re-
inspection fee (``average burden per response'' in table 2, row 1).
As described in section III.D of the guidance, certain outsourcing
facilities may qualify for a small business reduction in the amount of
the annual establishment fee. To qualify for this reduction, an
outsourcing facility must submit to FDA a written request certifying
that the entity meets the requirements for the reduction. For every
fiscal year that the firm seeks to qualify as a small business and
receive the fee reduction, the written request must be submitted to FDA
by April 30 of the preceding fiscal year. For example, an outsourcing
facility must submit a written request for the small business reduction
by April 30, 2015, to qualify for a reduction in the fiscal year 2016
annual establishment fee. As described in the guidance, section 744K of
the FD&C Act (21 U.S.C. 379j-62) also
[[Page 27495]]
requires an outsourcing facility to submit its written request for a
small business reduction in a format specified by FDA in the guidance.
The guidance specifies that Form FDA 3908 is the format for submitting
requests for a small business fee reduction.
We estimate that annually a total of 15 outsourcing facilities
(``number of respondents'' in table 1, row 2) will submit to FDA a
request for a small business reduction in the amount of the annual
establishment fee. We estimate that 15 outsourcing facilities will
submit Form FDA 3908 (``total annual responses'' in table 1, row 2) to
FDA annually, as described in the guidance, and that it will take an
outsourcing facility 25 hours to prepare and submit to FDA each Form
FDA 3908 (``average burden per response'' in table 1, row 2).
As described in section III.D of the guidance, those outsourcing
facilities that request a small business reduction in the amount of the
annual establishment fee will receive a small business designation
letter notifying the facility of FDA's decision. Outsourcing facilities
eligible to pay a reduced fee should maintain a copy of the small
business designation letter applicable to that fiscal year for their
records.
We estimate that annually a total of 15 outsourcing facilities
(``number of recordkeepers'' in table 3) will keep a copy of their
small business designation letter (``total annual records'' in table
3), and that maintaining each record will take 0.5 hour (``average
burden per recordkeeping'' in table 3).
As described in section V.B of the guidance, an outsourcing
facility may request reconsideration under 21 CFR 10.75 of an FDA
decision related to the fee provisions of section 744K of the FD&C Act.
As explained in the guidance, the request should state the facility's
rationale for its position that the decision was in error and include
any additional information that is relevant to the outsourcing
facility's argument.
We estimate that a total of three outsourcing facilities (``number
of respondents'' in table 2, row 2) annually will submit to FDA a
request for reconsideration as described in the guidance. We estimate
that it will take an outsourcing facility approximately 1 hour to
prepare and submit to FDA each request for reconsideration (``average
burden per response'' in table 2, row 2).
As described in section V.B of the guidance, an outsourcing
facility may appeal, as set forth in Sec. 10.75, an FDA denial of a
request for reconsideration of an FDA decision related to the fee
provisions of section 744K of the FD&C Act.
We estimate that a total of one outsourcing facility (``number of
respondents'' in table 2, row 3) annually will submit an appeal of an
FDA denial of a request for reconsideration. We estimate that it will
take an outsourcing facility 1 hour to prepare and submit each appeal
under Sec. 10.75 (``average burden per response'' in table 2, row 3).
The estimated reporting and recordkeeping burdens for this
collection of information are as follows:
Table 1--Estimated Annual Reporting Burden--Establishment Fee \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of reporting Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Payment of annual establishment fee......... 60 1 60 .5 (30 minutes)........................... 30
Request for Small Business Establishment Fee 15 1 15 25........................................ 375
Reduction (FDA Form 3908).
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 405
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Reporting Burden--Re-Inspection Fee and Dispute Resolution Requests \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of reporting Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Payment of re-inspection fee................ 15 1 15 .5 (30 minutes)........................... 7.50
Reconsideration request..................... 3 1 3 1......................................... 3
Appeal request.............................. 1 1 1 1......................................... 1
-----------------------------------------------------------------------------------------------------------
Total................................... .............. .............. .............. .......................................... 11.50
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 3--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Type of recordkeeping Number of records per Total annual Average burden per record Total hours
recordkeepers recordkeeper records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Copy of small business designation letter... 15 1 15 .5 (30 minutes)........................... 7.50
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
[[Page 27496]]
Dated: June 9, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12353 Filed 6-14-17; 8:45 am]
BILLING CODE 4164-01-P