Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarketing Adverse Drug and Biological Product Experience Reporting and Recordkeeping, 55900-55902 [2018-24442]
Download as PDF
<![CDATA[
daltland on DSKBBV9HB2PROD with NOTICES
55900
Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices
Based on FDA data, we estimate that
1,480 respondents will submit 2,960
new establishment registrations
annually. Based on the number of
registered establishments in our
database, we estimate 10,000 registrants
will provide 10,000 annual reviews and
updates of registration information
(including expedited updates) or
reviews and certifications that no
changes have occurred. The estimates
include the registration of
establishments for both domestic and
foreign manufacturers, repackers,
relabelers, and drug product salvagers,
and registration information submitted
by anyone acting as an authorized agent
for an establishment that manufactures,
repacks, relabels, or salvages drugs. The
estimates include an additional 80
positron emission tomography (PET)
drug producers who are not exempt
from registration and approximately 30
manufacturers of plasma derivatives.
We estimate that it will take 1 hour
for registrants to submit initial
registration information electronically
for each new establishment. We also
estimate that it will take approximately
30 minutes for each annual review and
update of registration information
(including any expedited updates) or
each review and certification that no
changes have occurred. The burden
hour estimates above are based on our
familiarity with the amount of time it
takes registrants to input registration
information electronically since June
2009. The estimates are an average of
the time it would take to register a
domestic or foreign establishment and
an average of the time it would take to
review registration information and
update several registration items in the
database or review registration
information and only certify that no
changes have occurred.
Based on the number of drugs listed
annually since June 2009, we estimate
that approximately 1,713 registrants will
report 12,469 new listings annually
(including the information submitted to
obtain a labeler code and to reserve an
NDC for future use).
Based on the number of drugs in our
listing database and the current number
of changes to listing information
submitted, we estimate 5,300 registrants
will each report 20 reviews and updates
(including the information submitted to
revise an NDC) for a total of 106,000
annually.
The estimates for the number of drug
listings include both domestic and
foreign listings, listings submitted by
registrants for products sold under their
own names as well as products intended
for private label distribution, and
information submitted related to an
VerDate Sep<11>2014
16:51 Nov 07, 2018
Jkt 247001
NDC and to obtain a labeler code. The
estimate for the number of drugs subject
to the listing requirements includes PET
drugs and approximately 30 plasma
derivatives. The estimates for the
number of June and December reviews
and updates of listing information
include the number of changes to drug
characteristics pertaining to the drug
product code to obtain a new NDC and
the reports of the withdrawal of an
approved drug from sale under
§ 314.81(b)(3)(iii) (21 CFR
314.81(b)(3)(iii)).
Based on our familiarity with the time
required to input listing information
electronically since June 2009, we
estimate that it will take registrants 1
hour and 30 minutes to submit
information electronically for each drug
they list for the first time (for both
foreign and domestic registrant listings).
These estimates are an average of the
time it will take manufacturers,
repackers, relabelers, and drug product
salvagers, with drug product salvagers
taking considerably less time than
manufacturers. The estimates include
the time for submitting the content of
labeling and other labeling in electronic
format. (For drugs subject to an
approved marketing application, the
electronic submission of the content of
labeling under § 314.50(l)(1)(i) is
approved under OMB control number
0910–0001.) We also estimate that it
will take 45 minutes for each June and
December review and update. These
estimates represent the average amount
of time to review and update listing
information or to review and certify that
no changes have occurred. The
estimates include the time for
submitting any labeling for each drug,
changes to the drug’s characteristics
submitted for a new NDC, and reports
of the withdrawal of an approved drug
from sale under § 314.81(b)(3)(iii).
In 2009, to help respondents
transition to the current electronic
reporting requirements, FDA issued the
guidance for industry entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Drug Establishment
Registration and Drug Listing.’’ The
document provides guidance to industry
on the statutory requirement to submit
electronically drug establishment
registration and drug listing
information. The guidance describes the
types of information to include for
purposes of drug establishment
registration and drug listing and how to
prepare and submit the information in
an electronic format (Structured Product
Labeling (SPL) files) that FDA can
process, review, and archive. The
burden attributed to the guidance
includes the preparation of an SOP for
PO 00000
Frm 00050
Fmt 4703
Sfmt 4703
creating and uploading the SPL file.
Although most firms will already have
prepared an SOP for the electronic
submission of drug establishment
registration and drug listing
information, each year additional firms
will need to create an SOP. As reflected
in table 2, FDA estimates that
approximately 1,000 firms will expend
40 hours to prepare, review, and
approve an SOP, for a total of 40,000
hours annually.
Cumulatively, the information
collection reflects a decrease of 3,295 in
both annual responses and burden
hours. This adjustment results from
eliminating burden previously
attributable to guidance
recommendations for creating drug
establishment registration and drug
listing files for electronic submission.
Because electronic registration and
listing is now mandatory, we believe
respondents have since developed and
implemented SOPs consistent with
meeting the technical format
specifications set forth in the
regulations and we no longer attribute
burden to this activity.
Dated: November 5, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24440 Filed 11–7–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0253]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Postmarketing
Adverse Drug and Biological Product
Experience Reporting and
Recordkeeping
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 December
10, 2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
SUMMARY:
E:\FR\FM\08NON1.SGM
08NON1
Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices
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 0910–0230. 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.
daltland on DSKBBV9HB2PROD with NOTICES
Postmarketing Adverse Drug and
Biological Product Experience
Reporting and Recordkeeping
OMB Control Number 0910–0230—
Revision
Sections 201, 502, 505, and 701 of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 321, 352, 355, and 371)
(FD&C Act) require that marketed drugs
be safe and effective. To monitor the
safety and efficacy of drugs that are on
the market, FDA must be promptly
informed of adverse experiences
associated with the use of marketed
drugs. We have issued regulations at
§§ 310.305 and 314.80 (21 CFR 310.305
and 314.80) to implement reporting and
recordkeeping requirements that enable
us to take necessary action to protect the
public health from adverse drug
experiences.
All applicants who have received
marketing approval of drug products are
required to report serious, unexpected
adverse drug experiences (15-day ‘‘Alert
reports’’), as well as follow-up reports
(§ 314.80(c)(1)). This includes reports of
all foreign or domestic adverse
experiences as well as those based on
information from applicable scientific
literature and certain reports from
postmarketing studies. Section
314.80(c)(1)(iii) pertains to such reports
submitted by nonapplicants.
Under § 314.80(c)(2), applicants must
provide periodic reports of adverse drug
experiences. A periodic report includes,
for the reporting interval, reports of
serious, expected adverse drug
experiences and all nonserious adverse
drug experiences and an index of these
reports, a narrative summary and
analysis of adverse drug experiences, an
analysis of the 15-day Alert reports
VerDate Sep<11>2014
16:51 Nov 07, 2018
Jkt 247001
submitted during the reporting interval,
and a history of actions taken because
of adverse drug experiences. Under
§ 314.80(j), applicants must keep for 10
years records of all adverse drug
experience reports known to the
applicant.
For marketed prescription drug
products without approved new drug
applications or abbreviated new drug
applications, manufacturers, packers,
and distributors are required to report to
FDA serious, unexpected adverse drug
experiences as well as follow-up reports
(§ 310.305(c)). Section 310.305(c)(5)
pertains to the submission of follow-up
reports to reports forwarded to the
manufacturers, packers, and distributors
by FDA. Under § 310.305(g), each
manufacturer, packer, and distributor
shall maintain for 10 years records of all
adverse drug experiences required to be
reported.
Section 760 of the Act (21 U.S.C.
379aa), also provides for mandatory
safety reporting for over-the-counter
(OTC) human drug products not subject
to applications approved under section
505 of the Act (new drug applications or
abbreviated new drug applications).
These requirements apply to all OTC)
drug products marketed without an
approved application, including those
marketed under the OTC Drug
Monograph Review process (whether or
not subject to a final monograph), those
marketed outside the monograph
system, and including those that have
been discontinued from marketing but
for which a report of an adverse event
was received. Under 21 CFR part
329.100 respondents must submit
section 760 reports in an electronic
format.
To assist respondents with
implementation of section 760 we
developed the guidance document
entitled ‘‘Postmarketing Adverse Event
Reporting for Nonprescription Human
Drug Products Marketed Without an
Approved Application.’’ The guidance
document discusses what should be
included in a serious adverse drug event
report submitted under section 760(b)(1)
of the FD&C Act (21 U.S.C. 379aa(b)(1)),
including follow-up reports under
760(c)(2) of the FD&C Act (21 U.S.C.
379aa(c)(2)), and how to submit these
reports.
Section 760(e) of the FD&C Act (21
U.S.C. 379aa(e)) also requires that
responsible persons maintain records of
nonprescription adverse event reports,
whether or not the event is serious, for
a period of 6 years. The guidance
recommends that respondents maintain
records of efforts to obtain the minimum
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
55901
data elements for a report of a serious
adverse drug event and any follow-up
reports. The information collection
associated with the guidance is
currently approved under OMB Control
No. 0910–0636, however we are now
consolidating it into this collection.
The primary purpose of FDA’s
adverse drug experience reporting
system is to enable identification of
signals for potentially serious safety
problems with marketed drugs.
Although premarket testing discloses a
general safety profile of a new drug’s
comparatively common adverse effects,
the larger and more diverse patient
populations exposed to the marketed
drug provide the opportunity to collect
information on rare, latent, and longterm effects. Signals are obtained from
a variety of sources, including reports
from patients, treating physicians,
foreign regulatory agencies, and clinical
investigators. Information derived from
the adverse drug experience reporting
system contributes directly to increased
public health protection because the
information enables us to make
important changes to the product’s
labeling (such as adding a new
warning), to make decisions about risk
evaluation and mitigation strategies or
the need for postmarketing studies or
clinical trials, and when necessary, to
initiate removal of a drug from the
market.
In the Federal Register of July 11,
2018 (83 FR 32132) we published a 60day notice requesting public comment
on the proposed collection of
information approved under OMB
Control No. 0910–0230. One comment
from an anonymous source referred us
to attachments that were not
successfully transmitted. We are
therefore unable to address this
comment. In the Federal Register of
August 15, 2018 (83 FR 40520) we
published a 60-day notice requesting
public comment on the collection of
information approved under OMB
Control No 0910–0636. No comments
were received.
Respondents to the collection of
information are manufacturers, packers,
distributors, and applicants of FDAregulated drug and biological products.
The following estimates are based on
our knowledge of adverse drug
experience reporting, including the time
needed to prepare the reports and the
number of reports submitted to the
Agency.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\08NON1.SGM
08NON1
55902
Federal Register / Vol. 83, No. 217 / Thursday, November 8, 2018 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
Number of
respondents
21 CFR section
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
310.305(c)(5) ........................................................................
314.80(c)(1)(iii) .....................................................................
314.80(c)(2) ..........................................................................
Reports of serious adverse drug events (21 U.S.C.
379aa((b) and (c)) ............................................................
3
5
810
1
1
17.19
3
5
13,923.90
1
1
60
3
5
835,434
283
687.099
194,449
6
1,166,694
Total ..............................................................................
........................
........................
........................
........................
2,002,136
1 The
2 The
reporting burden for § 310.305(c)(1), (2), and (3), and § 314.80(c)(1)(i) and (ii) is covered under OMB control number 0910–0645.
capital costs or operating and maintenance costs associated with this collection of information are approximately $25,000 annually.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 2
Number of
recordkeepers
21 CFR section
Average
burden per
recordkeeping
Total annual
records
Total
hours
310.305(g) ............................................................................
314.80(j) ...............................................................................
Recordkeeping (21 U.S.C. 379aa(e)(1)) ..............................
25
352
300
1
1,870
885.6667
25
658,240
265,700
16
16
8
400
10,531,840
2,125,600
Total ..............................................................................
........................
........................
........................
........................
12,657,840
1 There
2 There
are no capital costs or operating costs associated with this collection of information.
are maintenance costs of approximately $22,000 annually.
Based on submissions received we
have increased our burden estimate for
reporting under part 314.80(c)(2) and
recordkeeping under part 314.80(j).
Additionally, and as previously stated,
we are consolidating burden associated
with reporting and recordkeeping under
section 760 of the FD&C Act. Based on
our records, we received 194,449 total
annual reports from approximately 283
respondents for nonprescription drugs
marketed without an approved
application. We estimate each
submission takes approximately 6 hours
to prepare and submit. We estimate that
there are 265,700 records per year
maintained by approximately 300
respondents, and that it takes 8 hours to
maintain each record.
Dated: November 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–24442 Filed 11–7–18; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
daltland on DSKBBV9HB2PROD with NOTICES
Number of
records per
recordkeeper
National Institute on Drug Abuse;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
VerDate Sep<11>2014
16:51 Nov 07, 2018
Jkt 247001
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; R13
Conference Grant Review.
Date: November 14, 2018.
Time: 12:00 p.m. to 3:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852, (Telephone
Conference Call).
Contact Person: Ipolia R. Ramadan, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, Division of
Extramural Research, National Institute on
Drug Abuse, NIH, DHHS, 6001 Executive
Boulevard, Room 4228, MSC 9550, Bethesda,
MD 20892, 301–827–5842, ramadanir@
mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: National Institute on
Drug Abuse Special Emphasis Panel; Multisite Clinical Trials.
Date: November 16, 2018.
Time: 12:00 p.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
Place: National Institutes of Health,
Neuroscience Center, 6001 Executive
Boulevard, Rockville, MD 20852 (Telephone
Conference Call).
Contact Person: Ipolia R. Ramadan, Ph.D.,
Scientific Review Officer, Office of
Extramural Policy and Review, Division of
Extramural Research, National Institute on
Drug Abuse, NIH, DHHS, 6001 Executive
Boulevard, Room 4228, MSC 9550, Bethesda,
MD 20892, 301–827–5842, ramadanir@
mail.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos.: 93.279, Drug Abuse and
Addiction Research Programs, National
Institutes of Health, HHS)
Dated: November 2, 2018.
Natasha M. Copeland,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2018–24470 Filed 11–7–18; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
E:\FR\FM\08NON1.SGM
08NON1
]]>Agencies
[Federal Register Volume 83, Number 217 (Thursday, November 8, 2018)]
[Notices]
[Pages 55900-55902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-24442]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0253]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Postmarketing Adverse
Drug and Biological Product Experience Reporting and Recordkeeping
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
December 10, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of
[[Page 55901]]
Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax:
202-395-7285, or emailed to [email protected]. All comments
should be identified with the OMB control number 0910-0230. 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,
[email protected].
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.
Postmarketing Adverse Drug and Biological Product Experience Reporting
and Recordkeeping
OMB Control Number 0910-0230--Revision
Sections 201, 502, 505, and 701 of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 321, 352, 355, and 371) (FD&C Act) require that
marketed drugs be safe and effective. To monitor the safety and
efficacy of drugs that are on the market, FDA must be promptly informed
of adverse experiences associated with the use of marketed drugs. We
have issued regulations at Sec. Sec. 310.305 and 314.80 (21 CFR
310.305 and 314.80) to implement reporting and recordkeeping
requirements that enable us to take necessary action to protect the
public health from adverse drug experiences.
All applicants who have received marketing approval of drug
products are required to report serious, unexpected adverse drug
experiences (15-day ``Alert reports''), as well as follow-up reports
(Sec. 314.80(c)(1)). This includes reports of all foreign or domestic
adverse experiences as well as those based on information from
applicable scientific literature and certain reports from postmarketing
studies. Section 314.80(c)(1)(iii) pertains to such reports submitted
by nonapplicants.
Under Sec. 314.80(c)(2), applicants must provide periodic reports
of adverse drug experiences. A periodic report includes, for the
reporting interval, reports of serious, expected adverse drug
experiences and all nonserious adverse drug experiences and an index of
these reports, a narrative summary and analysis of adverse drug
experiences, an analysis of the 15-day Alert reports submitted during
the reporting interval, and a history of actions taken because of
adverse drug experiences. Under Sec. 314.80(j), applicants must keep
for 10 years records of all adverse drug experience reports known to
the applicant.
For marketed prescription drug products without approved new drug
applications or abbreviated new drug applications, manufacturers,
packers, and distributors are required to report to FDA serious,
unexpected adverse drug experiences as well as follow-up reports (Sec.
310.305(c)). Section 310.305(c)(5) pertains to the submission of
follow-up reports to reports forwarded to the manufacturers, packers,
and distributors by FDA. Under Sec. 310.305(g), each manufacturer,
packer, and distributor shall maintain for 10 years records of all
adverse drug experiences required to be reported.
Section 760 of the Act (21 U.S.C. 379aa), also provides for
mandatory safety reporting for over-the-counter (OTC) human drug
products not subject to applications approved under section 505 of the
Act (new drug applications or abbreviated new drug applications). These
requirements apply to all OTC) drug products marketed without an
approved application, including those marketed under the OTC Drug
Monograph Review process (whether or not subject to a final monograph),
those marketed outside the monograph system, and including those that
have been discontinued from marketing but for which a report of an
adverse event was received. Under 21 CFR part 329.100 respondents must
submit section 760 reports in an electronic format.
To assist respondents with implementation of section 760 we
developed the guidance document entitled ``Postmarketing Adverse Event
Reporting for Nonprescription Human Drug Products Marketed Without an
Approved Application.'' The guidance document discusses what should be
included in a serious adverse drug event report submitted under section
760(b)(1) of the FD&C Act (21 U.S.C. 379aa(b)(1)), including follow-up
reports under 760(c)(2) of the FD&C Act (21 U.S.C. 379aa(c)(2)), and
how to submit these reports.
Section 760(e) of the FD&C Act (21 U.S.C. 379aa(e)) also requires
that responsible persons maintain records of nonprescription adverse
event reports, whether or not the event is serious, for a period of 6
years. The guidance recommends that respondents maintain records of
efforts to obtain the minimum data elements for a report of a serious
adverse drug event and any follow-up reports. The information
collection associated with the guidance is currently approved under OMB
Control No. 0910-0636, however we are now consolidating it into this
collection.
The primary purpose of FDA's adverse drug experience reporting
system is to enable identification of signals for potentially serious
safety problems with marketed drugs. Although premarket testing
discloses a general safety profile of a new drug's comparatively common
adverse effects, the larger and more diverse patient populations
exposed to the marketed drug provide the opportunity to collect
information on rare, latent, and long-term effects. Signals are
obtained from a variety of sources, including reports from patients,
treating physicians, foreign regulatory agencies, and clinical
investigators. Information derived from the adverse drug experience
reporting system contributes directly to increased public health
protection because the information enables us to make important changes
to the product's labeling (such as adding a new warning), to make
decisions about risk evaluation and mitigation strategies or the need
for postmarketing studies or clinical trials, and when necessary, to
initiate removal of a drug from the market.
In the Federal Register of July 11, 2018 (83 FR 32132) we published
a 60-day notice requesting public comment on the proposed collection of
information approved under OMB Control No. 0910-0230. One comment from
an anonymous source referred us to attachments that were not
successfully transmitted. We are therefore unable to address this
comment. In the Federal Register of August 15, 2018 (83 FR 40520) we
published a 60-day notice requesting public comment on the collection
of information approved under OMB Control No 0910-0636. No comments
were received.
Respondents to the collection of information are manufacturers,
packers, distributors, and applicants of FDA-regulated drug and
biological products. The following estimates are based on our knowledge
of adverse drug experience reporting, including the time needed to
prepare the reports and the number of reports submitted to the Agency.
We estimate the burden of this collection of information as
follows:
[[Page 55902]]
Table 1--Estimated Annual Reporting Burden \1\ \2\
----------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
310.305(c)(5)................... 3 1 3 1 3
314.80(c)(1)(iii)............... 5 1 5 1 5
314.80(c)(2).................... 810 17.19 13,923.90 60 835,434
Reports of serious adverse drug 283 687.099 194,449 6 1,166,694
events (21 U.S.C. 379aa((b) and
(c))...........................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 2,002,136
----------------------------------------------------------------------------------------------------------------
\1\ The reporting burden for Sec. 310.305(c)(1), (2), and (3), and Sec. 314.80(c)(1)(i) and (ii) is covered
under OMB control number 0910-0645.
\2\ The capital costs or operating and maintenance costs associated with this collection of information are
approximately $25,000 annually.
Table 2--Estimated Annual Recordkeeping Burden \1\ \2\
----------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
----------------------------------------------------------------------------------------------------------------
310.305(g)...................... 25 1 25 16 400
314.80(j)....................... 352 1,870 658,240 16 10,531,840
Recordkeeping (21 U.S.C. 300 885.6667 265,700 8 2,125,600
379aa(e)(1))...................
-------------------------------------------------------------------------------
Total....................... .............. .............. .............. .............. 12,657,840
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating costs associated with this collection of information.
\2\ There are maintenance costs of approximately $22,000 annually.
Based on submissions received we have increased our burden estimate
for reporting under part 314.80(c)(2) and recordkeeping under part
314.80(j). Additionally, and as previously stated, we are consolidating
burden associated with reporting and recordkeeping under section 760 of
the FD&C Act. Based on our records, we received 194,449 total annual
reports from approximately 283 respondents for nonprescription drugs
marketed without an approved application. We estimate each submission
takes approximately 6 hours to prepare and submit. We estimate that
there are 265,700 records per year maintained by approximately 300
respondents, and that it takes 8 hours to maintain each record.
Dated: November 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-24442 Filed 11-7-18; 8:45 am]
BILLING CODE 4164-01-P
