Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act, 48090-48092 [2017-22283]
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48090
Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Application .......................................................................................................
Annual Report ..................................................................................................
Estimated Total Annual Burden
Hours: 3,328.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research,
and Evaluation, 330 C Street SW.,
Washington, DC 20201, Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
requests should be identified by the title
of the information collection.
The Department specifically requests
comments on (a) whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Mary Jones,
ACF/OPRE Reports Clearance Officer.
[FR Doc. 2017–22294 Filed 10–13–17; 8:45 am]
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52
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–D–0329]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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.
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:
Fax written comments on the
collection of information by November
15, 2017.
DATES:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0776. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
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.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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Sfmt 4703
Number of
responses per
respondent
1
1
Average
burden hours
per response
40
24
Total burden
hours
2,080
1,248
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
This information collection supports
the Agency’s guidance on fees for
human drug compounding outsourcing
facilities under the Federal Food, Drug,
and Cosmetic Act (the FD&C Act). 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.
In the Federal Register of June 15,
2017 (82 FR 27493), we published a 60day notice requesting public comment
on the proposed extension of this
collection of information. No comments
were received. We therefore estimate the
burden associated with the information
collection as follows:
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48091
Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—ESTABLISHMENT FEE 1
Number of
respondents
Type of reporting
Number of
responses
per
respondent
Average
burden per
response
Total annual
responses
Total hours
Payment of annual establishment fee ...........................
Request for Small Business Establishment Fee Reduction (Form FDA 3908) ................................................
60
1
60
.5 (30 minutes)
30
15
1
15
25
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
Average
burden per
response
Total annual
responses
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
record per
recordkeeper
15
Average
burden per
record
Total annual
records
1
15
.5 (30 minutes)
Total hours
7.50
are no capital costs or operating and maintenance costs associated with this collection 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 (‘‘no. 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
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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 (‘‘no. 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
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Sfmt 4703
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
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 (‘‘no. 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).
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Federal Register / Vol. 82, No. 198 / Monday, October 16, 2017 / Notices
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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 (‘‘no. 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 (‘‘no. 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 § 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 (‘‘no. 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).
Dated: October 10, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis.
[FR Doc. 2017–22283 Filed 10–13–17; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1429]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
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.
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.
DATES: Fax written comments on the
collection of information by November
15, 2017.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0777. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUMMARY:
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
This information collection supports
the above captioned Agency guidance.
A facility that compounds drugs may
elect to register with FDA as an
outsourcing facility under section 503B
of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 353b), as
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Frm 00043
Fmt 4703
Sfmt 4703
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 of the
FD&C Act 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 and phone number. 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
• 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.
In the Federal Register of June 20,
2017 (82 FR 28076), FDA published a
60-day notice requesting public
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Agencies
[Federal Register Volume 82, Number 198 (Monday, October 16, 2017)]
[Notices]
[Pages 48090-48092]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22283]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-D-0329]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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) 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.
DATES: Fax written comments on the collection of information by
November 15, 2017.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to oira_submission@omb.eop.gov. All
comments should be identified with the OMB control number 0910-0776.
Also include the FDA docket number found in brackets in the heading of
this document.
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: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
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
This information collection supports the Agency's guidance on fees
for human drug compounding outsourcing facilities under the Federal
Food, Drug, and Cosmetic Act (the FD&C Act). 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.
In the Federal Register of June 15, 2017 (82 FR 27493), we
published a 60-day notice requesting public comment on the proposed
extension of this collection of information. No comments were received.
We therefore estimate the burden associated with the information
collection as follows:
[[Page 48091]]
Table 1--Estimated Annual Reporting Burden--Establishment Fee \1\
----------------------------------------------------------------------------------------------------------------
Number of
Type of reporting Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Payment of annual 60 1 60 .5 (30 minutes) 30
establishment fee...........
Request for Small Business 15 1 15 25 375
Establishment Fee Reduction
(Form FDA 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 Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
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 record per Total annual Average burden Total hours
recordkeepers recordkeeper records per record
----------------------------------------------------------------------------------------------------------------
Copy of small business 15 1 15 .5 (30 minutes) 7.50
designation letter..........
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection 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
(``no. 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
(``no. 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 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
(``no. 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).
[[Page 48092]]
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
(``no. 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 (``no. 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 (``no. 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).
Dated: October 10, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22283 Filed 10-13-17; 8:45 am]
BILLING CODE 4164-01-P