Agency Information Collection Activities; Submission for Office of Management and Budget Review; Adverse Experience Reporting for Licensed Biological Products; and General Records, 819-821 [2018-00095]
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Federal Register / Vol. 83, No. 5 / Monday, January 8, 2018 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–10401]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995 (the
PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
March 9, 2018.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs
Division of Regulations Development;
Attention: Document Identifier/OMB
Control Number lll, Room C4–26–
05, 7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
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SUMMARY:
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proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
https://www.cms.hhs.gov/Paperwork
ReductionActof1995.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–10401 Standards Related to
Reinsurance, Risk Corridors, and
Risk Adjustment
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.
The term ‘‘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
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
819
individual and small group health
insurance markets inside and outside of
the Health Insurance Exchanges. HHS
will also use this data to adjust the
payment transfer formula for risk
associated with high-cost enrollees.
State regulators can use the reporting
requirements outlined in this collection
to request a reduction to the statewide
average premium factor of the risk
adjustment transfer formula, beginning
for the 2019 benefit year, and thereby
avoid having to establish their own
programs. Issuers and providers can use
the alternative reporting requirements
for mental and behavioral health records
described herein to comply with State
privacy laws. Form Number: CMS–
10401 (OMB control number: 0938–
1155); Frequency: Yearly; Affected
Public: State, Local, or Tribal
Governments; Number of Respondents:
700; Total Annual Responses:
11,700,000,287; Total Annual Hours:
5,828,037. (For policy questions
regarding this collection contact Ernest
Ayukawa at 410–492–5213.)
Dated: January 2, 2018.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2018–00086 Filed 1–5–18; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0231]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Adverse Experience Reporting for
Licensed Biological Products; and
General Records
AGENCY:
Information Collection
1. Type of Information Collection
Request: Revision of a previously
approved collection; Title of
Information Collection: Standards
Related to Reinsurance, Risk Corridors,
and Risk Adjustment; Use: The data
collection and reporting requirements
described below will be used by HHS to
run the permanent risk adjustment
program, including validation of data
submitted by issuers, on behalf of States
that requested HHS to run it for them.
Risk adjustment is one of three (3)
market stability programs established by
the Patient Protection and Affordable
Care Act and is intended to mitigate the
impact of adverse selection in the
ACTION:
Food and Drug Administration,
HHS.
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Notice.
The Food and Drug
Administration (FDA or we) 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 February 7,
2018.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
SUMMARY:
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Federal Register / Vol. 83, No. 5 / Monday, January 8, 2018 / Notices
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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 0910–0308. Also
include the FDA docket number found
in brackets in the heading of this
document.
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: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Adverse Experience Reporting For
Licensed Biological Products; and
General Records—21 CFR Part 600;
OMB Control Number 0910–0308—
Extension
Under the Public Health Service Act
(42 U.S.C. 262), FDA may only approve
a biologics license application for a
biological product that is safe, pure, and
potent. When a biological product is
approved and enters the market, the
product is introduced to a larger patient
population in settings different from
clinical trials. New information
generated during the postmarketing
period offers further insight into the
benefits and risks of the product, and
evaluation of this information is
important to ensure its safe use. FDA
issued the Adverse Experience
Reporting (AER) requirements in part
600 (21 CFR part 600) to enable FDA to
take actions necessary for the protection
of the public health in response to
reports of adverse experiences related to
licensed biological products. The
primary purpose of FDA’s AERS is to
identify potentially serious safety
problems with licensed biological
products. Although premarket testing
discloses a general safety profile of a
biological product’s comparatively
common adverse effects, the larger and
more diverse patient populations
exposed to the licensed biological
product provides the opportunity to
collect information on rare, latent, and
long-term effects. In addition,
production and/or distribution
problems have contaminated biological
products in the past. AER reports are
obtained from a variety of sources,
including manufacturers, patients,
physicians, foreign regulatory agencies,
and clinical investigators. Identification
of new and unexpected safety issues
through the analysis of the data in AERS
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contributes directly to increased public
health protection. For example,
evaluation of these safety issues enables
FDA to take focused regulatory action.
Such action may include, but is not
limited to, important changes to the
product’s labeling (such as adding a
new warning), coordination with
manufacturers to ensure adequate
corrective action is taken, and removal
of a biological product from the market
when necessary.
Section 600.80(c)(1) requires licensed
manufacturers or any person whose
name appears on the label of a licensed
biological product to report each
adverse experience that is both serious
and unexpected, whether foreign or
domestic, as soon as possible but in no
case later than 15 calendar days of
initial receipt of the information by the
licensed manufacturer. These reports
are known as postmarketing 15-day
Alert reports. This section also requires
licensed manufacturers to submit any
followup reports within 15 calendar
days of receipt of new information or as
requested by FDA, and if additional
information is not obtainable, to
maintain records of the unsuccessful
steps taken to seek additional
information. In addition, this section
requires that a person who submits an
adverse action report to the licensed
manufacturer rather than to FDA,
maintain a record of this action. Section
600.80(e) requires licensed
manufacturers to submit a 15-day Alert
report for an adverse experience
obtained from a postmarketing clinical
study only if the licensed manufacturer
concludes that there is a reasonable
possibility that the product caused the
adverse experience. Section 600.80(c)(2)
requires licensed manufacturers to
report each adverse experience not
reported in a postmarketing 15-day
Alert report at quarterly intervals, for 3
years from the date of issuance of the
biologics license, and then at annual
intervals. The majority of these periodic
reports are submitted annually, since a
large percentage of currently licensed
biological products have been licensed
longer than 3 years. Section 600.80(k)
requires licensed manufacturers to
maintain for a period of 10 years records
of all adverse experiences known to the
licensed manufacturer, including raw
data and any correspondence relating to
the adverse experiences. Section 600.81
requires licensed manufacturers to
submit, at an interval of every 6 months,
information about the quantity of the
product distributed under the biologics
license, including the quantity
distributed to distributors. These
distribution reports provide FDA with
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important information about products
distributed under biologics licenses,
including the quantity, certain lot
numbers, labeled date of expiration, the
fill lot numbers for the total number of
dosage units of each strength or potency
distributed (e.g., 50,000 per 10-milliliter
vials), and date of release. FDA may
require the licensed manufacturer to
submit distribution reports under this
section at times other than every 6
months. Under § 600.82(a), an applicant
of a biological product or blood and
blood component must notify FDA of a
permanent discontinuance of
manufacture or an interruption in
manufacturing or disruption in supply,
as applicable. Under §§ 600.80(h)(2) and
600.81(b)(2), a licensed manufacturer
may request a temporary waiver for the
requirements under § 600.80(h)(1) and
(b)(1), respectively. Requests for waivers
must be submitted in accordance with
§ 600.90. Under § 600.90, a licensed
manufacturer may submit a waiver
request for any requirements that apply
to the licensed manufacturer under
§§ 600.80 and 600.81. A waiver request
submitted under § 600.90 must include
supporting documentation.
Manufacturers of biological products
for human use must keep records of
each step in the manufacture and
distribution of a product, including any
recalls. These recordkeeping
requirements serve preventative and
remedial purposes by establishing
accountability and traceability in the
manufacture and distribution of
products. These requirements also
enable FDA to perform meaningful
inspections. Section 600.12 requires,
among other things, that records be
made concurrently with the
performance of each step in the
manufacture and distribution of
products. These records must be
retained for no less than 5 years after the
records of manufacture have been
completed or 6 months after the latest
expiration date for the individual
product, whichever represents a later
date. In addition, under § 600.12,
manufacturers must maintain records
relating to the sterilization of equipment
and supplies, animal necropsy records,
and records in cases of divided
manufacturing responsibility with
respect to a product. Under
§ 600.12(b)(2), manufacturers are also
required to maintain complete records
pertaining to the recall from distribution
of any product. Furthermore, § 610.18(b)
(21 CFR 610.18(b)) requires, in part, that
the results of all periodic tests for
verification of cultures and
determination of freedom from
extraneous organisms be recorded and
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Federal Register / Vol. 83, No. 5 / Monday, January 8, 2018 / Notices
retained. The recordkeeping
requirements for §§ 610.12(g),
610.13(a)(2), 610.18(d), 21 CFR 680.2(f),
and 680.3(f) are approved under OMB
control number 0910–0139.
Respondents to this collection of
information include manufacturers of
biological products (including blood
and blood components) and any person
whose name appears on the label of a
licensed biological product. In table 1,
the number of respondents is based on
the estimated number of manufacturers
that are subject to those regulations or
that submitted the required information
to the Center for Biologics Evaluation
and Research and Center for Drugs
Evaluation and Research, FDA, in fiscal
year (FY) 2016. Based on information
obtained from the FDA’s database
system, there were 93 manufacturers of
biological products. This number
excludes those manufacturers who
produce Whole Blood, components of
Whole Blood, or in-vitro diagnostic
licensed products, because of the
exemption under § 600.80(m). The total
annual responses are based on the
number of submissions received by FDA
in FY 2016. There were an estimated
125,371 15-day Alert reports, 180,580
periodic reports, and 677 lot
distribution reports submitted to FDA.
The number of 15-day Alert reports for
postmarketing studies under § 600.80(e)
is included in the total number of 15day Alert reports. FDA received 81
requests from 40 manufacturers for
waivers under § 600.90 (including
§§ 600.80(h)(2) and 600.81(b)(2)), of
which 79 were granted. The hours per
response are based on FDA experience.
The burden hours required to complete
the MedWatch Form (Form FDA 3500A)
for § 600.80(c)(1), (e), and (f) are
reported under OMB control number
0910–0291.
In the Federal Register of July 18,
2017 (82 FR 32836), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
600.80(c)(1), 600.80(d), and 600.80(e);
postmarketing 15-day Alert reports ....
600.82; notification of discontinuance or
interruption in manufacturing ..............
600.80(c)(2); periodic adverse experience reports .......................................
600.81 Distribution Reports ...................
600.80(h)(2), 600.81(b)(2), and 600.90;
waiver requests ..................................
Total ................................................
1 There
Number of
responses per
respondent
Number of
respondents
21 CFR Section
Average burden
per response (in
hours)
Total annual
responses
Total hours
93
1,348.07
125,371
1
125,371
18
1.61
29
2
58
93
93
1,941.72
7.28
180,580
677
28
1
5,056,240
677
40
2.03
81
1
81
..............................
..............................
..............................
..............................
5,182,427
are no capital costs or operating and maintenance costs associated with this collection of information.
In table 2 the number of respondents
is based on the number of
manufacturers subject to those
regulations. Based on information
obtained from FDA’s database system,
there were 263 licensed manufacturers
of biological products in FY 2016.
However, the number of recordkeepers
listed for § 600.12(a) through (e)
excluding (b)(2) is estimated to be 114.
This number excludes manufacturers of
blood and blood components because
their burden hours for recordkeeping
have been reported under § 606.160 in
OMB control number 0910–0116. The
total annual records is based on the
annual average of lots released in FY
2016 (7,198), number of recalls made
(575), and total number of adverse
experience reports received (305,951) in
FY 2016. The hours per record are based
on FDA experience.
FDA estimates the burden of this
recordkeeping as follows:
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR Section
Number of
records per
recordkeeper
Total annual
records
Average
burden per
recordkeeper
(in hours)
Total hours
600.12 2; maintenance of records ........................................
600.12(b)(2); recall records .................................................
600.80(c)(1) and 600.80(k) ..................................................
114
263
93
63.14
2.19
3,289.79
7,198
575
305,951
32
24
1
230,336
13,800
305,951
Total ..............................................................................
........................
........................
........................
........................
550,087
1 There
sradovich on DSK3GMQ082PROD with NOTICES
2 The
are no capital costs or operating and maintenance costs associated with this collection of information.
recordkeeping requirements in § 610.18(b) are included in the estimate for § 600.12.
The burden for this information
collection has changed since the last
OMB approval. Because of an increase
in the number of AER reports we have
received during the past 3years, we have
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increased our reporting and
recordkeeping burden estimates.
PO 00000
Dated: January 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–00095 Filed 1–5–18; 8:45 am]
BILLING CODE 4164–01–P
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]]>Agencies
[Federal Register Volume 83, Number 5 (Monday, January 8, 2018)]
[Notices]
[Pages 819-821]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-00095]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0231]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Adverse Experience Reporting for
Licensed Biological Products; and General Records
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) 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
February 7, 2018.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs,
[[Page 820]]
OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to
[email protected]. All comments should be identified with the
OMB control number 0910-0308. Also include the FDA docket number found
in brackets in the heading of this document.
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,
[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.
Adverse Experience Reporting For Licensed Biological Products; and
General Records--21 CFR Part 600; OMB Control Number 0910-0308--
Extension
Under the Public Health Service Act (42 U.S.C. 262), FDA may only
approve a biologics license application for a biological product that
is safe, pure, and potent. When a biological product is approved and
enters the market, the product is introduced to a larger patient
population in settings different from clinical trials. New information
generated during the postmarketing period offers further insight into
the benefits and risks of the product, and evaluation of this
information is important to ensure its safe use. FDA issued the Adverse
Experience Reporting (AER) requirements in part 600 (21 CFR part 600)
to enable FDA to take actions necessary for the protection of the
public health in response to reports of adverse experiences related to
licensed biological products. The primary purpose of FDA's AERS is to
identify potentially serious safety problems with licensed biological
products. Although premarket testing discloses a general safety profile
of a biological product's comparatively common adverse effects, the
larger and more diverse patient populations exposed to the licensed
biological product provides the opportunity to collect information on
rare, latent, and long-term effects. In addition, production and/or
distribution problems have contaminated biological products in the
past. AER reports are obtained from a variety of sources, including
manufacturers, patients, physicians, foreign regulatory agencies, and
clinical investigators. Identification of new and unexpected safety
issues through the analysis of the data in AERS contributes directly to
increased public health protection. For example, evaluation of these
safety issues enables FDA to take focused regulatory action. Such
action may include, but is not limited to, important changes to the
product's labeling (such as adding a new warning), coordination with
manufacturers to ensure adequate corrective action is taken, and
removal of a biological product from the market when necessary.
Section 600.80(c)(1) requires licensed manufacturers or any person
whose name appears on the label of a licensed biological product to
report each adverse experience that is both serious and unexpected,
whether foreign or domestic, as soon as possible but in no case later
than 15 calendar days of initial receipt of the information by the
licensed manufacturer. These reports are known as postmarketing 15-day
Alert reports. This section also requires licensed manufacturers to
submit any followup reports within 15 calendar days of receipt of new
information or as requested by FDA, and if additional information is
not obtainable, to maintain records of the unsuccessful steps taken to
seek additional information. In addition, this section requires that a
person who submits an adverse action report to the licensed
manufacturer rather than to FDA, maintain a record of this action.
Section 600.80(e) requires licensed manufacturers to submit a 15-day
Alert report for an adverse experience obtained from a postmarketing
clinical study only if the licensed manufacturer concludes that there
is a reasonable possibility that the product caused the adverse
experience. Section 600.80(c)(2) requires licensed manufacturers to
report each adverse experience not reported in a postmarketing 15-day
Alert report at quarterly intervals, for 3 years from the date of
issuance of the biologics license, and then at annual intervals. The
majority of these periodic reports are submitted annually, since a
large percentage of currently licensed biological products have been
licensed longer than 3 years. Section 600.80(k) requires licensed
manufacturers to maintain for a period of 10 years records of all
adverse experiences known to the licensed manufacturer, including raw
data and any correspondence relating to the adverse experiences.
Section 600.81 requires licensed manufacturers to submit, at an
interval of every 6 months, information about the quantity of the
product distributed under the biologics license, including the quantity
distributed to distributors. These distribution reports provide FDA
with important information about products distributed under biologics
licenses, including the quantity, certain lot numbers, labeled date of
expiration, the fill lot numbers for the total number of dosage units
of each strength or potency distributed (e.g., 50,000 per 10-milliliter
vials), and date of release. FDA may require the licensed manufacturer
to submit distribution reports under this section at times other than
every 6 months. Under Sec. 600.82(a), an applicant of a biological
product or blood and blood component must notify FDA of a permanent
discontinuance of manufacture or an interruption in manufacturing or
disruption in supply, as applicable. Under Sec. Sec. 600.80(h)(2) and
600.81(b)(2), a licensed manufacturer may request a temporary waiver
for the requirements under Sec. 600.80(h)(1) and (b)(1), respectively.
Requests for waivers must be submitted in accordance with Sec. 600.90.
Under Sec. 600.90, a licensed manufacturer may submit a waiver request
for any requirements that apply to the licensed manufacturer under
Sec. Sec. 600.80 and 600.81. A waiver request submitted under Sec.
600.90 must include supporting documentation.
Manufacturers of biological products for human use must keep
records of each step in the manufacture and distribution of a product,
including any recalls. These recordkeeping requirements serve
preventative and remedial purposes by establishing accountability and
traceability in the manufacture and distribution of products. These
requirements also enable FDA to perform meaningful inspections. Section
600.12 requires, among other things, that records be made concurrently
with the performance of each step in the manufacture and distribution
of products. These records must be retained for no less than 5 years
after the records of manufacture have been completed or 6 months after
the latest expiration date for the individual product, whichever
represents a later date. In addition, under Sec. 600.12, manufacturers
must maintain records relating to the sterilization of equipment and
supplies, animal necropsy records, and records in cases of divided
manufacturing responsibility with respect to a product. Under Sec.
600.12(b)(2), manufacturers are also required to maintain complete
records pertaining to the recall from distribution of any product.
Furthermore, Sec. 610.18(b) (21 CFR 610.18(b)) requires, in part, that
the results of all periodic tests for verification of cultures and
determination of freedom from extraneous organisms be recorded and
[[Page 821]]
retained. The recordkeeping requirements for Sec. Sec. 610.12(g),
610.13(a)(2), 610.18(d), 21 CFR 680.2(f), and 680.3(f) are approved
under OMB control number 0910-0139.
Respondents to this collection of information include manufacturers
of biological products (including blood and blood components) and any
person whose name appears on the label of a licensed biological
product. In table 1, the number of respondents is based on the
estimated number of manufacturers that are subject to those regulations
or that submitted the required information to the Center for Biologics
Evaluation and Research and Center for Drugs Evaluation and Research,
FDA, in fiscal year (FY) 2016. Based on information obtained from the
FDA's database system, there were 93 manufacturers of biological
products. This number excludes those manufacturers who produce Whole
Blood, components of Whole Blood, or in-vitro diagnostic licensed
products, because of the exemption under Sec. 600.80(m). The total
annual responses are based on the number of submissions received by FDA
in FY 2016. There were an estimated 125,371 15-day Alert reports,
180,580 periodic reports, and 677 lot distribution reports submitted to
FDA. The number of 15-day Alert reports for postmarketing studies under
Sec. 600.80(e) is included in the total number of 15-day Alert
reports. FDA received 81 requests from 40 manufacturers for waivers
under Sec. 600.90 (including Sec. Sec. 600.80(h)(2) and
600.81(b)(2)), of which 79 were granted. The hours per response are
based on FDA experience. The burden hours required to complete the
MedWatch Form (Form FDA 3500A) for Sec. 600.80(c)(1), (e), and (f) are
reported under OMB control number 0910-0291.
In the Federal Register of July 18, 2017 (82 FR 32836), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR Section Number of responses per Total annual per response (in Total hours
respondents respondent responses hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
600.80(c)(1), 600.80(d), and 600.80(e); postmarketing 15- 93 1,348.07 125,371 1 125,371
day Alert reports.......................................
600.82; notification of discontinuance or interruption in 18 1.61 29 2 58
manufacturing...........................................
600.80(c)(2); periodic adverse experience reports........ 93 1,941.72 180,580 28 5,056,240
600.81 Distribution Reports.............................. 93 7.28 677 1 677
600.80(h)(2), 600.81(b)(2), and 600.90; waiver requests.. 40 2.03 81 1 81
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Total................................................ ................. ................. ................. ................. 5,182,427
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
In table 2 the number of respondents is based on the number of
manufacturers subject to those regulations. Based on information
obtained from FDA's database system, there were 263 licensed
manufacturers of biological products in FY 2016. However, the number of
recordkeepers listed for Sec. 600.12(a) through (e) excluding (b)(2)
is estimated to be 114. This number excludes manufacturers of blood and
blood components because their burden hours for recordkeeping have been
reported under Sec. 606.160 in OMB control number 0910-0116. The total
annual records is based on the annual average of lots released in FY
2016 (7,198), number of recalls made (575), and total number of adverse
experience reports received (305,951) in FY 2016. The hours per record
are based on FDA experience.
FDA estimates the burden of this recordkeeping as follows:
Table 2--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Average burden
Number of Number of Total annual per
21 CFR Section recordkeepers records per records recordkeeper Total hours
recordkeeper (in hours)
----------------------------------------------------------------------------------------------------------------
600.12 \2\; maintenance of 114 63.14 7,198 32 230,336
records........................
600.12(b)(2); recall records.... 263 2.19 575 24 13,800
600.80(c)(1) and 600.80(k)...... 93 3,289.79 305,951 1 305,951
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Total....................... .............. .............. .............. .............. 550,087
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ The recordkeeping requirements in Sec. 610.18(b) are included in the estimate for Sec. 600.12.
The burden for this information collection has changed since the
last OMB approval. Because of an increase in the number of AER reports
we have received during the past 3years, we have increased our
reporting and recordkeeping burden estimates.
Dated: January 2, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00095 Filed 1-5-18; 8:45 am]
BILLING CODE 4164-01-P
