Agency Information Collection Activities; Proposed Collection; Comment Request; Exports: Notification and Recordkeeping Requirements, 4473-4475 [2019-02480]
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Federal Register / Vol. 84, No. 32 / Friday, February 15, 2019 / Notices
Seema Verma
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
cc: Benjamin R. Cohen
Electronic Submissions
Section 1116 of the Social Security Act (42
U.S.C. 1316; 42 CFR 430.18) (Catalog of
Federal Domestic Assistance program No.
13.714. Medicaid Assistance Program.)
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’’).
Dallas, TX 75202
214-767-4461
Sincerely,
Dated: February 11, 2019.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2019–02401 Filed 2–14–19; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0801]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Exports:
Notification and Recordkeeping
Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
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 export notification
and recordkeeping requirements for
persons exporting human drugs,
biological products, devices, animal
drugs, food, cosmetics, and tobacco that
may not be marketed or sold in the
United States.
DATES: Submit either electronic or
written comments on the collection of
information by April 16, 2019.
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 April 16,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 16, 2019. Comments
received by mail/hand delivery/courier
khammond on DSKBBV9HB2PROD with NOTICES
SUMMARY:
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Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2014–N–0801 for ‘‘Agency Information
Collection Activities; Proposed
Collection: Comment Request; Exports:
Notification and Recordkeeping
Requirements.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
PO 00000
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Fmt 4703
Sfmt 4703
4473
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, 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
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4474
Federal Register / Vol. 84, No. 32 / Friday, February 15, 2019 / Notices
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.
Exports: Notification and
Recordkeeping Requirements—21 CFR
1.101
OMB Control Number 0910–0482—
Extension
Section 801 of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act) (21
U.S.C. 381) charges the Secretary of
Health and Human Services, through
FDA, with the responsibility of helping
to ensure that exports of unapproved
new drugs, biologics, devices, animal
drugs, food, cosmetics, and tobacco
products which are not to be sold in the
United States meet the requirements of
the country to which the product is to
be exported. The respondents to this
information collection are exporters
who have notified FDA of their intent to
export unapproved products that may
not be sold or offered for sale in
domestic commerce in the United States
as allowed under section 801(e) of the
FD&C Act. In general, the notification
identifies the product being exported
(e.g. name, description, and in some
cases, country of destination) and
specifies where the notifications were
sent. These notifications are sent only
for an initial export. Subsequent exports
of the same product to the same
destination or in the case of certain
countries identified in section 802(b) of
the FD&C Act (21 U.S.C. 382) would not
result in a notification to FDA.
The recordkeepers for this
information collection are exporters of
products that may not be sold in the
United States who are regulated by the
following FDA Centers: Center for Drug
Evaluation and Research (CDER)
(human drugs); Center for Biologics
Evaluation and Research (CBER)
(biologics); Center for Devices and
Radiological Health (CDRH) (medical
devices); Center for Veterinary Medicine
(CVM) (animal drugs); Center for Food
Safety and Applied Nutrition (CFSAN)
(foods and cosmetics); and Center for
Tobacco Products (CTP) (tobacco
products). Respondents to this
collection of information maintain
records demonstrating their compliance
with the requirements in 21 CFR 1.101.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR Section
Number of
responses per
respondent
Total annual
responses
Average
burden per
response
Total hours
1.101(d) (CBER) ..................................................................
1.101(d) (CDER) ..................................................................
1.101(d) (CDRH) ..................................................................
5
5
160
92
180
1
460
900
160
15
15
15
6,900
13,500
2,400
Total ..............................................................................
........................
........................
........................
........................
22,800
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Total annual
records
Average
burden per
recordkeeping
Total hours
1.101 (b), (c), (e) (CBER, CDER, CDRH, CFSAN, and
CVM) ................................................................................
1.101(b) Office of International Programs only ...................
1.101(b) (currently regulated Tobacco Products) ................
320
1
322
3
189
3
960
189
966
22
22
22
21,120
4,158
21,252
Total ..............................................................................
........................
........................
........................
........................
46,530
1 There
khammond on DSKBBV9HB2PROD with NOTICES
Number of
records per
recordkeeper
are no capital costs or operating and maintenance costs associated with this collection of information.
We have adjusted our burden
estimate, which has resulted in an
overall decrease of 129,543 hours to the
currently approved burden. The
reporting burden estimate for CDRH has
been adjusted to correct an error and
corresponding miscalculation in the
previous burden estimate and has been
updated based on recent internal data.
This adjustment contributed to the
overall burden estimate reduction by
VerDate Sep<11>2014
19:41 Feb 14, 2019
Jkt 247001
eliminating 8,030 responses and
120,450 hours from the reporting
burden estimate. CBER’s estimated
reporting burden for the information
collection in table 1 reflects a decrease
of 7,575 hours and a corresponding
decrease of total annual responses (193
to 92). We attribute this adjustment to
a normal variation in the number of
submissions we received over the last
few years. CTP’s current number of
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
respondents and recordkeeping burden
hours in table 2 are expected to decrease
by 23 respondents and 1,518 hours. This
is based on summary derived from the
monthly operational reports that
manufacturers and importers of tobacco
products are required to file with the
Alcohol and Tobacco Tax and Trade
Bureau.
E:\FR\FM\15FEN1.SGM
15FEN1
Federal Register / Vol. 84, No. 32 / Friday, February 15, 2019 / Notices
Dated: February 11, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–02480 Filed 2–14–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–N–4000]
Framework for a Real-World Evidence
Program; Availability; Reopening of
the Comment Period
AGENCY:
Food and Drug Administration,
HHS.
Notice of availability; reopening
of the comment period.
ACTION:
The Food and Drug
Administration (FDA or the Agency) is
reopening the comment period for the
document entitled ‘‘Framework for a
Real-World Evidence Program;
Availability’’ that appeared in the
Federal Register on December 7, 2018.
The Agency is taking this action to
allow interested persons additional time
to submit comments.
DATES: FDA is reopening the comment
period on the document published
December 7, 2018 (83 FR 63178).
Submit either electronic or written
comments on the document by April 16,
2019.
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 April 16,
2019. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of April 16, 2019. 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.
khammond on DSKBBV9HB2PROD with NOTICES
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
VerDate Sep<11>2014
19:41 Feb 14, 2019
Jkt 247001
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–N–4000 for ‘‘Framework for a
Real-World Evidence Program;
Availability.’’ Received comments,
those filed in a timely manner (see
ADDRESSES), will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
4475
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Dianne Paraoan, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 3326,
Silver Spring, MD 20993–0002, 301–
796–2500, dianne.paraoan@fda.hhs.gov;
or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911, stephen.ripley@fda.hhs.gov.
In the
Federal Register of December 7, 2018
(83 FR 63178), FDA published a notice
of availability with a 60-day comment
period to request comments on the
framework entitled ‘‘Framework for a
Real-World Evidence Program.’’ That
document established a public docket to
collect comments on this framework
created by the Center for Drug
Evaluation and Research and Center for
Biologics Evaluation and Research for
implementing a program to evaluate the
potential use of real-world evidence in
regulatory decision making. The
document requested comments by
February 5, 2019. Based on the public
interest underlying the notice, FDA is
reopening the comment period until
April 16, 2019. The Agency believes
that reopening the comment period for
60 days allows adequate time for
interested persons to submit comments.
SUPPLEMENTARY INFORMATION:
Dated: February 12, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019–02561 Filed 2–14–19; 8:45 am]
BILLING CODE 4164–01–P
E:\FR\FM\15FEN1.SGM
15FEN1
]]>Agencies
[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Notices]
[Pages 4473-4475]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-02480]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0801]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Exports: Notification and Recordkeeping Requirements
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 export notification and recordkeeping
requirements for persons exporting human drugs, biological products,
devices, animal drugs, food, cosmetics, and tobacco that may not be
marketed or sold in the United States.
DATES: Submit either electronic or written comments on the collection
of information by April 16, 2019.
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 April 16, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of April 16, 2019. 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2014-N-0801 for ``Agency Information Collection Activities;
Proposed Collection: Comment Request; Exports: Notification and
Recordkeeping Requirements.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
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
[[Page 4474]]
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.
Exports: Notification and Recordkeeping Requirements--21 CFR 1.101
OMB Control Number 0910-0482--Extension
Section 801 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 381) charges the Secretary of Health and Human
Services, through FDA, with the responsibility of helping to ensure
that exports of unapproved new drugs, biologics, devices, animal drugs,
food, cosmetics, and tobacco products which are not to be sold in the
United States meet the requirements of the country to which the product
is to be exported. The respondents to this information collection are
exporters who have notified FDA of their intent to export unapproved
products that may not be sold or offered for sale in domestic commerce
in the United States as allowed under section 801(e) of the FD&C Act.
In general, the notification identifies the product being exported
(e.g. name, description, and in some cases, country of destination) and
specifies where the notifications were sent. These notifications are
sent only for an initial export. Subsequent exports of the same product
to the same destination or in the case of certain countries identified
in section 802(b) of the FD&C Act (21 U.S.C. 382) would not result in a
notification to FDA.
The recordkeepers for this information collection are exporters of
products that may not be sold in the United States who are regulated by
the following FDA Centers: Center for Drug Evaluation and Research
(CDER) (human drugs); Center for Biologics Evaluation and Research
(CBER) (biologics); Center for Devices and Radiological Health (CDRH)
(medical devices); Center for Veterinary Medicine (CVM) (animal drugs);
Center for Food Safety and Applied Nutrition (CFSAN) (foods and
cosmetics); and Center for Tobacco Products (CTP) (tobacco products).
Respondents to this collection of information maintain records
demonstrating their compliance with the requirements in 21 CFR 1.101.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR Section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
1.101(d) (CBER)................. 5 92 460 15 6,900
1.101(d) (CDER)................. 5 180 900 15 13,500
1.101(d) (CDRH)................. 160 1 160 15 2,400
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Total....................... .............. .............. .............. .............. 22,800
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
1.101 (b), (c), (e) (CBER, CDER, 320 3 960 22 21,120
CDRH, CFSAN, and CVM)..........
1.101(b) Office of International 1 189 189 22 4,158
Programs only..................
1.101(b) (currently regulated 322 3 966 22 21,252
Tobacco Products)..............
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Total....................... .............. .............. .............. .............. 46,530
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
We have adjusted our burden estimate, which has resulted in an
overall decrease of 129,543 hours to the currently approved burden. The
reporting burden estimate for CDRH has been adjusted to correct an
error and corresponding miscalculation in the previous burden estimate
and has been updated based on recent internal data. This adjustment
contributed to the overall burden estimate reduction by eliminating
8,030 responses and 120,450 hours from the reporting burden estimate.
CBER's estimated reporting burden for the information collection in
table 1 reflects a decrease of 7,575 hours and a corresponding decrease
of total annual responses (193 to 92). We attribute this adjustment to
a normal variation in the number of submissions we received over the
last few years. CTP's current number of respondents and recordkeeping
burden hours in table 2 are expected to decrease by 23 respondents and
1,518 hours. This is based on summary derived from the monthly
operational reports that manufacturers and importers of tobacco
products are required to file with the Alcohol and Tobacco Tax and
Trade Bureau.
[[Page 4475]]
Dated: February 11, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-02480 Filed 2-14-19; 8:45 am]
BILLING CODE 4164-01-P
