Draft Guidance for Industry on Interim Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act; Availability, 72897-72899 [2013-28960]
Download as PDF
<![CDATA[
Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Notices
72897
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued
Number of
recordkeepers
21 CFR Part
Number of
records per
recordkeeper
Total
annual records
Total ..............................................................................
Average
burden per
recordkeeping
Total hours
806,770
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 Review and update of standard operating procedures (SOPs).
3 Documentation of deviations from SOPs.
Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
SUMMARY:
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Lysette Deshields, Drug Registration and
Listing Team, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–3100.
SUPPLEMENTARY INFORMATION:
Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on a
draft guidance describing the updated
format for long-term use, submit either
electronic or written comments on this
draft guidance by February 3, 2014.
Submit either electronic or written
comments concerning the collection of
information proposed in the draft
guidance by February 3, 2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Interim Product Reporting for Human
Drug Compounding Outsourcing
Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act.’’
The draft guidance is being issued to
implement new provisions added to the
FD&C Act in the DQSA. In the newly
enacted legislation, Congress created a
new statutory category of ‘‘outsourcing
facilities’’ that compound drugs. New
section 503B of the FD&C Act (21 U.S.C.
353b) allows compounders to register
with FDA as outsourcing facilities and,
among other things, imposes reporting
requirements on these entities if they
choose to register. The draft guidance is
intended to assist registered outsourcing
facilities in implementing drug
reporting. The draft guidance describes
how an outsourcing facility should
provide interim electronic reports while
FDA modifies its existing electronic
drug registration and listing system to
accommodate reporting of product
information by registered outsourcing
facilities under section 503B of the
FD&C Act. When the Agency has
modified its current electronic
submission system to allow outsourcing
[FR Doc. 2013–28989 Filed 12–3–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1428]
Draft Guidance for Industry on Interim
Product Reporting for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Interim
Product Reporting for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’ The
draft guidance addresses new provisions
in the Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as amended by the
Drug Quality and Security Act (DQSA),
and sets forth an interim electronic
submission method for human drug
compounders that choose to register as
outsourcing facilities (outsourcing
facilities).
EMCDONALD on DSK67QTVN1PROD with NOTICES
DATES:
VerDate Mar<15>2010
17:09 Dec 03, 2013
Jkt 232001
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
facilities to submit information
electronically through a Structured
Product Labeling file, FDA intends to
issue a draft guidance describing the
updated format for long-term use. When
such guidance is issued in final form, it
will specify the form of reporting that
outsourcing facilities are to follow from
that point forward.
The draft guidance does not create or
confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
Elsewhere in this issue of the Federal
Register, the Agency is making available
for comment a draft guidance on
registration for human drug
compounding outsourcing facilities
under section 503B of the FD&C Act.
II. Paperwork Reduction Act
Under the Paperwork Reduction Act
of 1995 (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 that 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 for each proposed
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 collection of
information associated with this
document, FDA invites comments on
the following topics: (1) Whether the
proposed information collected is
necessary for the proper performance of
FDA’s functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’s estimated
burden of the proposed information
collected, including the validity of the
methodology and assumptions used; (3)
E:\FR\FM\04DEN1.SGM
04DEN1
72898
Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Notices
ways to enhance the quality, utility, and
clarity of the information collected; and
(4) ways to minimize the burden of
information collected on the
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Under the draft guidance, registered
outsourcing facilities should submit to
FDA a report identifying all drugs
compounded by the facility during the
previous 6-month period. This product
report should be submitted upon initial
registration as an outsourcing facility
and once during the months of June and
December of each year. The report
should include the following
information for all drugs compounded
by the outsourcing facility during the
previous 6-month period:
• The active ingredient and strength
of active ingredient per unit;
• The source of the active ingredient
(bulk or finished drug);
• The National Drug Code (NDC)
number of the source drug or bulk active
ingredient, if available;
• The dosage form and route of
administration;
• The package description;
• The number of individual units
produced; and
• The NDC number of the final
product, if assigned.
Product reports should be submitted
to FDA electronically using an Excel
spreadsheet and via an email
attachment, as described in the draft
guidance. Outsourcing facilities may
request a waiver from the electronic
submission process by submitting a
written request to FDA explaining why
the use of electronic means is not
reasonable.
Because human drug compounders
are not required to register and report as
outsourcing facilities, it is difficult to
anticipate the number of outsourcing
facilities that will participate in the
process. We estimate that a total of
approximately 20 outsourcing facilities
(‘‘number of respondents’’ in table 1,
row 1) will submit to FDA at the time
of initial registration a report identifying
all drugs compounded by the facility.
We also estimate that these outsourcing
facilities will submit a total of
approximately 20 reports for
compounded drugs containing the
information specified in the draft
guidance (‘‘total annual responses’’ in
table 1, row 1). We estimate that
preparing and submitting this
information electronically will take
approximately 10 hours per report
(‘‘average burden per response’’ in table
1, row 1). We expect to receive no more
than one waiver request from this
electronic submission process (‘‘total
annual responses’’ in table 1, row 2),
and each request should take
approximately 1 hour to prepare and
submit to us (‘‘average burden per
response’’ in table 1, row 2).
We also estimate that a total of
approximately 20 outsourcing facilities
(‘‘number of respondents’’ in table 2,
row 1) will annually submit to FDA a
report identifying all drugs
compounded by the facility. We
estimate that these outsourcing facilities
will submit a total of approximately 20
reports in June and 20 reports in
December containing the information
specified in the draft guidance (‘‘total
annual responses’’ in table 2, row 1). We
estimate that preparing and submitting
this information electronically will take
approximately 10 hours per report
(‘‘average burden per response’’ in table
2, row 1). We expect to receive no more
than one waiver request from the
electronic submission process (‘‘total
annual responses’’ in table 2, row 2),
and each request should take
approximately 1 hour to prepare and
submit to us (‘‘average burden per
response’’ in table 2, row 2).
TABLE 1—ESTIMATED ONE-TIME REPORTING BURDEN 1
Product reporting for compounding outsourcing facilities
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours
Submission of Initial Product Report ...................................
Waiver Request from Electronic Submission of Initial Product Report .........................................................................
20
1
20
10
200
1
1
1
1
1
Total ..............................................................................
........................
........................
........................
........................
201
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1
Product reporting for compounding outsourcing facilities
Number of
responses per
respondent
Number of
respondents
Average
burden per
response
Total annual
responses
Total hours
Submission of June Product Report ....................................
Submission of December Product Report ...........................
Waiver Request from Electronic Submission of Product
Reports .............................................................................
20
20
1
1
20
20
10
10
200
200
1
1
1
1
1
Total ..............................................................................
........................
........................
........................
........................
401
EMCDONALD on DSK67QTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
VerDate Mar<15>2010
17:09 Dec 03, 2013
Jkt 232001
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
E:\FR\FM\04DEN1.SGM
04DEN1
Federal Register / Vol. 78, No. 233 / Wednesday, December 4, 2013 / Notices
Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–28960 Filed 12–2–13; 11:15 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–1429]
Draft Guidance for Industry on
Registration for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Registration for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’ The
draft guidance addresses new provisions
in the Federal Food, Drug, and Cosmetic
Act (the FD&C Act), as amended by the
Drug Quality and Security Act (DQSA).
The draft guidance is intended to assist
human drug compounders that choose
to register as outsourcing facilities
(outsourcing facilities) in registering
with FDA. The draft guidance provides
information on how an outsourcing
facility should submit facility
registration information electronically.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by February 3,
2014. Submit either electronic or
written comments concerning the
collection of information proposed in
the draft guidance by February 3, 2014.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
EMCDONALD on DSK67QTVN1PROD with NOTICES
SUMMARY:
VerDate Mar<15>2010
17:09 Dec 03, 2013
Jkt 232001
Submit electronic comments on the
draft guidance to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Soo
Jin Park, Drug Registration and Listing
Team, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–3100.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Registration for Human Drug
Compounding Outsourcing Facilities
Under Section 503B of the Federal
Food, Drug, and Cosmetic Act.’’ The
draft guidance is being issued to
implement new provisions added to the
FD&C Act in the DQSA. In the newly
enacted legislation, Congress created a
new statutory category of ‘‘outsourcing
facilities’’ that compound human drugs.
New section 503B of the FD&C Act (21
U.S.C. 353b) allows compounders to
register with FDA as outsourcing
facilities. The draft guidance discusses
the process for registration of
outsourcing facilities.
The draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on registration for outsourcing facilities
under section 503B of the FD&C Act. It
does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
Elsewhere in this issue of the Federal
Register, the Agency is making available
for comment a draft guidance on interim
product reporting for human drug
compounding outsourcing facilities
under section 503B of the FD&C Act.
II. Paperwork Reduction Act
Under the Paperwork Reduction Act
of 1995 (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 that 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
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
72899
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 for each proposed
collection of information before
submitting the collection to OMB for
approval. To comply with this
requirement, FDA is publishing this
notice of the proposed collection of
information set forth in this document.
With respect to the collection of
information associated with this
document, FDA invites comments on
the following topics: (1) Whether the
proposed information collected is
necessary for the proper performance of
FDA’s functions, including whether the
information will have practical utility;
(2) the accuracy of FDA’s estimated
burden of the proposed information
collected, including the validity of the
methodology and assumptions used; (3)
ways to enhance the quality, utility, and
clarity of the information collected; and
(4) ways to minimize the burden of
information collected on the
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Under the draft guidance, 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, within the next calendar
year, drugs that appear on FDA’s drug
shortage list in effect under section 506E
of the FD&C Act (21 U.S.C. 356e); and
• An indication of whether the
facility compounds from bulk drug
substances, and if so, whether it
compounds sterile drugs from bulk drug
substances.
After initial registration, outsourcing
facilities should register annually
between October 1 and December 31 of
each year. 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.’’ FDA is also providing an
alternative interim registration
mechanism for use after initial passage
of the DQSA because registration is a
new requirement for those outsourcing
facilities that elect to register under
section 503B and because FDA wants to
encourage registration of outsourcing
E:\FR\FM\04DEN1.SGM
04DEN1
]]>Agencies
[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Notices]
[Pages 72897-72899]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-28960]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-1428]
Draft Guidance for Industry on Interim Product Reporting for
Human Drug Compounding Outsourcing Facilities Under Section 503B of the
Federal Food, Drug, and Cosmetic Act; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a draft guidance for industry entitled
``Interim Product Reporting for Human Drug Compounding Outsourcing
Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic
Act.'' The draft guidance addresses new provisions in the Federal Food,
Drug, and Cosmetic Act (the FD&C Act), as amended by the Drug Quality
and Security Act (DQSA), and sets forth an interim electronic
submission method for human drug compounders that choose to register as
outsourcing facilities (outsourcing facilities).
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on a draft guidance describing the
updated format for long-term use, submit either electronic or written
comments on this draft guidance by February 3, 2014. Submit either
electronic or written comments concerning the collection of information
proposed in the draft guidance by February 3, 2014.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Lysette Deshields, Drug Registration
and Listing Team, Center for Drug Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002, 301-796-3100.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Interim Product Reporting for Human Drug Compounding
Outsourcing Facilities Under Section 503B of the Federal Food, Drug,
and Cosmetic Act.'' The draft guidance is being issued to implement new
provisions added to the FD&C Act in the DQSA. In the newly enacted
legislation, Congress created a new statutory category of ``outsourcing
facilities'' that compound drugs. New section 503B of the FD&C Act (21
U.S.C. 353b) allows compounders to register with FDA as outsourcing
facilities and, among other things, imposes reporting requirements on
these entities if they choose to register. The draft guidance is
intended to assist registered outsourcing facilities in implementing
drug reporting. The draft guidance describes how an outsourcing
facility should provide interim electronic reports while FDA modifies
its existing electronic drug registration and listing system to
accommodate reporting of product information by registered outsourcing
facilities under section 503B of the FD&C Act. When the Agency has
modified its current electronic submission system to allow outsourcing
facilities to submit information electronically through a Structured
Product Labeling file, FDA intends to issue a draft guidance describing
the updated format for long-term use. When such guidance is issued in
final form, it will specify the form of reporting that outsourcing
facilities are to follow from that point forward.
The draft guidance does not create or confer any rights for or on
any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
Elsewhere in this issue of the Federal Register, the Agency is
making available for comment a draft guidance on registration for human
drug compounding outsourcing facilities under section 503B of the FD&C
Act.
II. Paperwork Reduction Act
Under the Paperwork Reduction Act of 1995 (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 that
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 for each proposed 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 collection of information associated with this
document, FDA invites comments on the following topics: (1) Whether the
proposed information collected is necessary for the proper performance
of FDA's functions, including whether the information will have
practical utility; (2) the accuracy of FDA's estimated burden of the
proposed information collected, including the validity of the
methodology and assumptions used; (3)
[[Page 72898]]
ways to enhance the quality, utility, and clarity of the information
collected; and (4) ways to minimize the burden of information collected
on the respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.
Under the draft guidance, registered outsourcing facilities should
submit to FDA a report identifying all drugs compounded by the facility
during the previous 6-month period. This product report should be
submitted upon initial registration as an outsourcing facility and once
during the months of June and December of each year. The report should
include the following information for all drugs compounded by the
outsourcing facility during the previous 6-month period:
The active ingredient and strength of active ingredient
per unit;
The source of the active ingredient (bulk or finished
drug);
The National Drug Code (NDC) number of the source drug or
bulk active ingredient, if available;
The dosage form and route of administration;
The package description;
The number of individual units produced; and
The NDC number of the final product, if assigned.
Product reports should be submitted to FDA electronically using an
Excel spreadsheet and via an email attachment, as described in the
draft guidance. Outsourcing facilities may request a waiver from the
electronic submission process by submitting a written request to FDA
explaining why the use of electronic means is not reasonable.
Because human drug compounders are not required to register and
report as outsourcing facilities, it is difficult to anticipate the
number of outsourcing facilities that will participate in the process.
We estimate that a total of approximately 20 outsourcing facilities
(``number of respondents'' in table 1, row 1) will submit to FDA at the
time of initial registration a report identifying all drugs compounded
by the facility. We also estimate that these outsourcing facilities
will submit a total of approximately 20 reports for compounded drugs
containing the information specified in the draft guidance (``total
annual responses'' in table 1, row 1). We estimate that preparing and
submitting this information electronically will take approximately 10
hours per report (``average burden per response'' in table 1, row 1).
We expect to receive no more than one waiver request from this
electronic submission process (``total annual responses'' in table 1,
row 2), and each request should take approximately 1 hour to prepare
and submit to us (``average burden per response'' in table 1, row 2).
We also estimate that a total of approximately 20 outsourcing
facilities (``number of respondents'' in table 2, row 1) will annually
submit to FDA a report identifying all drugs compounded by the
facility. We estimate that these outsourcing facilities will submit a
total of approximately 20 reports in June and 20 reports in December
containing the information specified in the draft guidance (``total
annual responses'' in table 2, row 1). We estimate that preparing and
submitting this information electronically will take approximately 10
hours per report (``average burden per response'' in table 2, row 1).
We expect to receive no more than one waiver request from the
electronic submission process (``total annual responses'' in table 2,
row 2), and each request should take approximately 1 hour to prepare
and submit to us (``average burden per response'' in table 2, row 2).
Table 1--Estimated One-Time Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Product reporting for Number of
compounding outsourcing Number of responses per Total annual Average burden Total hours
facilities respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Submission of Initial Product 20 1 20 10 200
Report.........................
Waiver Request from Electronic 1 1 1 1 1
Submission of Initial Product
Report.........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 201
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Product reporting for Number of
compounding outsourcing Number of responses per Total annual Average burden Total hours
facilities respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Submission of June Product 20 1 20 10 200
Report.........................
Submission of December Product 20 1 20 10 200
Report.........................
Waiver Request from Electronic 1 1 1 1 1
Submission of Product Reports..
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 401
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
III. Comments
Interested persons may submit either electronic comments regarding
this document to https://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet may obtain the document at
either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov.
[[Page 72899]]
Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28960 Filed 12-2-13; 11:15 am]
BILLING CODE 4160-01-P
