Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Deviations in Manufacturing, 70979-70981 [2019-27791]
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Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / Notices
provisions in 21 CFR part 601 are
approved under OMB control number
0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/combinationproducts/guidance-regulatoryinformation/combination-productsguidance-documents or https://
www.regulations.gov.
Dated: December 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–27799 Filed 12–23–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0001]
The Tobacco Products Scientific
Advisory Committee; Notice of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) announces a
forthcoming public advisory committee
meeting of the Tobacco Products
Scientific Advisory Committee (TPSAC,
the Committee). The general function of
the Committee is to provide advice and
recommendations to the Agency on
FDA’s regulatory issues. The meeting
will be open to the public.
DATES: The meeting will be held on
February 14, 2020, from 8:30 a.m. to 5
p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Building
31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993–
0002. Answers to commonly asked
questions including information
regarding special accommodations due
to a disability, visitor parking, and
transportation may be accessed at:
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm408555.htm.
For those unable to attend in person,
the meeting will also be webcast and
will be available at the following link:
https://collaboration.fda.gov/
tpsac021420/.
FOR FURTHER INFORMATION CONTACT:
Serina Hunter-Thomas, Office of
Science, Center for Tobacco Products,
Food and Drug Administration,
Document Control Center, Bldg. 71, Rm.
G335, 10903 New Hampshire Ave.,
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
16:53 Dec 23, 2019
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Silver Spring, MD 20993–0002, 1–877–
287–1373, email: TPSAC@fda.hhs.gov,
or FDA Advisory Committee
Information Line, 1–800–741–8138
(301–443–0572 in the Washington, DC
area). A notice in the Federal Register
about last minute modifications that
impact a previously announced
advisory committee meeting cannot
always be published quickly enough to
provide timely notice. Therefore, you
should always check the Agency’s
website at https://www.fda.gov/
AdvisoryCommittees/default.htm and
scroll down to the appropriate advisory
committee meeting link, or call the
advisory committee information line to
learn about possible modifications
before coming to the meeting.
SUPPLEMENTARY INFORMATION:
Agenda: On February 14, 2020, the
Center for Tobacco Product’s TPSAC
will convene for one open session,
during which the Committee will
discuss the modified risk tobacco
product applications, submitted by
22nd Century Group Inc. for the
following combusted filtered cigarette
tobacco products:
• MR0000159: VLNTM King
• MR0000160: VLNTM Menthol King
FDA intends to make background
material available to the public no later
than 2 business days before the meeting.
If FDA is unable to post the background
material on its website prior to the
meeting, the background material will
be made publicly available at the
location of the advisory committee
meeting, and the background material
will be posted on FDA’s website after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
Procedure: Interested persons may
present data, information, or views,
orally or in writing, on issues pending
before the committee. Written
submissions may be made to the contact
person on or before February 7, 2020.
Oral presentations from the public will
be scheduled between
approximately10:45 a.m. and 11:45 a.m.
on February 14, 2020. Those individuals
interested in making formal oral
presentations should notify the contact
person (see FOR FURTHER INFORMATION
CONTACT) and submit a brief statement
describing the general nature of the
evidence or arguments they wish to
present and the names and email
addresses of proposed participants on or
before January 30, 2020, by 5 p.m.
Eastern Time. Time allotted for each
presentation may be limited. If the
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70979
number of registrants requesting to
speak is greater than can be reasonably
accommodated during the scheduled
open public hearing session, FDA may
conduct a lottery to determine the
speakers for the scheduled open public
hearing session. The contact person will
notify interested persons regarding their
request to speak by January 31, 2020.
Persons attending FDA’s advisory
committee meetings are advised that the
Agency is not responsible for providing
access to electrical outlets.
FDA welcomes the attendance of the
public at its advisory committee
meetings and will make every effort to
accommodate persons with disabilities.
If you require accommodations due to a
disability, please contact Serina HunterThomas at least 7 days in advance of the
meeting (see FOR FURTHER INFORMATION
CONTACT).
FDA is committed to the orderly
conduct of its advisory committee
meetings. Please visit our website at
https://www.fda.gov/Advisory
Committees/AboutAdvisoryCommittees/
ucm111462.htm for procedures on
public conduct during advisory
committee meetings.
Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: December 19, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–27774 Filed 12–23–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0579]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Biological
Products: Reporting of Biological
Product Deviations and Human Cells,
Tissues, and Cellular and TissueBased Deviations in Manufacturing
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 January 27,
2020.
SUMMARY:
E:\FR\FM\26DEN1.SGM
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Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / Notices
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0458. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Biological Products: Reporting of
Biological Product Deviations and
Human Cells, Tissues, and Cellular and
Tissue-Based Product Deviations in
Manufacturing; Forms FDA 3486 and
3486A
khammond on DSKJM1Z7X2PROD with NOTICES
OMB Control Number 0910–0458—
Extension
Under section 351 of the Public
Health Service Act (PHS Act) (42 U.S.C.
262), all biological products, including
human blood and blood components,
offered for sale in interstate commerce
must be licensed and meet standards,
including those prescribed in the FDA
regulations, designed to ensure the
continued safety, purity, and potency of
such products. In addition, under
section 361 of the PHS Act (42 U.S.C.
264), FDA may issue and enforce
regulations necessary to prevent the
introduction, transmission, or spread of
communicable diseases between the
States or possessions or from foreign
countries into the States or possessions.
Further, the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
351) provides that drugs and devices
(including human blood and blood
components) are adulterated if they do
not conform with current good
manufacturing practice (CGMP) assuring
that they meet the requirements of the
FD&C Act. Establishments
manufacturing biological products,
including human blood and blood
components, must comply with the
applicable CGMP regulations (parts 211,
606, and 820 (21 CFR parts 211, 606,
and 820)) and current good tissue
practice (CGTP) regulations (part 1271
VerDate Sep<11>2014
16:53 Dec 23, 2019
Jkt 250001
(21 CFR part 1271)) as appropriate. FDA
regards biological product deviation
(BPD) reporting and HCT/P deviation
reporting to be an essential tool in its
directive to protect public health by
establishing and maintaining
surveillance programs that provide
timely and useful information.
Section 600.14 (21 CFR 600.14), in
brief, requires the manufacturer who
holds the biological product license, for
other than human blood and blood
components, and who had control over
a distributed product when the
deviation occurred, to report to the
Center for Biologics Evaluation and
Research (CBER) or to the Center for
Drug Evaluation and Research (CDER) as
soon as possible but at a date not to
exceed 45 calendar days after acquiring
information reasonably suggesting that a
reportable event has occurred. Section
606.171, in brief, requires licensed
manufacturers of human blood and
blood components, including Source
Plasma, unlicensed registered blood
establishments, and transfusion
services, who had control over a
distributed product when the deviation
occurred, to report to CBER as soon as
possible but at a date not to exceed 45
calendar days after acquiring
information reasonably suggesting that a
reportable event has occurred.
Similarly, § 1271.350(b), in brief,
requires HCT/P establishments that
manufacture non-reproductive HCT/Ps
described in § 1271.10 to investigate and
report to CBER all HCT/P deviations
relating to a distributed HCT/P that
relates to the core CGTP requirements,
if the deviation occurred in the
establishment’s facility or in a facility
that performed a manufacturing step for
the establishment under contract,
agreement or other arrangement. Form
FDA 3486 is used to submit BPD reports
and HCT/P deviation reports.
Respondents to this collection of
information are: (1) Licensed
manufacturers of biological products
other than human blood and blood
components, (2) licensed manufacturers
of blood and blood components
including Source Plasma, (3) unlicensed
registered blood establishments, (4)
transfusion services, and (5)
establishments that manufacture nonreproductive HCT/Ps regulated solely
under section 361 of the PHS Act as
described in § 1271.10. The number of
respondents and total annual responses
are based on the BPD reports and HCT/
P deviation reports FDA received in
fiscal year 2018. The number of licensed
manufacturers and total annual
responses under § 600.14 include the
estimates for BPD reports submitted to
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Sfmt 4703
both CBER and CDER. Based on the
information from industry, the
estimated average time to complete a
deviation report is 2 hours, which
includes a minimal one-time burden to
create a user account for those reports
submitted electronically. The
availability of the standardized report
form, Form FDA 3486, and the ability to
submit this report electronically to
CBER (CDER does not currently accept
electronic filings) further streamlines
the report submission process.
CBER has developed a Web-based
addendum to Form FDA 3486 (Form
FDA 3486A) to provide additional
information when a BPD report has been
reviewed by FDA and evaluated as a
possible recall. The additional
information requested includes
information not contained in the Form
FDA 3486 such as: (1) Distribution
pattern; (2) method of consignee
notification; (3) consignee(s) of products
for further manufacture; (4) additional
product information; (5) updated
product disposition; and (6) industry
recall contacts. This information is
requested by CBER through email
notification to the submitter of the BPD
report. This information is used by
CBER for recall classification purposes.
CBER estimates that 5 percent of the
total BPD reports submitted to CBER
would need additional information
submitted in the addendum. CBER
further estimates that it would take
between 10 to 20 minutes to complete
the addendum. For calculation
purposes, CBER is using 15 minutes.
Activities such as investigating,
changing standard operating procedures
or processes, and followup are currently
required under 21 CFR parts 211
(approved under OMB control number
0910–0139), 606 (approved under OMB
control number 0910–0116), 820
(approved under OMB control number
0910–0073), and 1271 (approved under
OMB control number 0910–0543) and,
therefore, are not included in the
burden calculation for the separate
requirement of submitting a deviation
report to FDA.
In the Federal Register of July 31,
2019 (84 FR 37321), we published a 60day notice requesting public comment
on the proposed collection of
information. One comment offering
general support for the information
collection was received.
We estimate the burden of this
collection of information as follows:
E:\FR\FM\26DEN1.SGM
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70981
Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
21 CFR section
600.14; Reporting of product deviations by licensed manufacturers ......................................................................................
606.171; Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and
transfusion services ...............................................................
1271.350(b); Reporting requirements (human cells, tissues,
and cellular and tissue-based products) ...............................
1271.350(b) (CBER addendum report) .....................................
Total ...................................................................................
Number of
responses per
respondent
Number of
respondents
FDA form No.
Total
annual
responses
Average
burden per
response
Total hours
3486
93
6.14
571
2.0
1,142
3486
1,937
23.847
46,192
2.0
92,384
3486
2 3486A
93
102
2.61
22.76
243
2,322
2.0
0.25
486
580.5
........................
........................
........................
49,328
........................
94,592.5
1 There
2 Five
are no capital costs or operating and maintenance costs associated with this collection of information.
percent of the number of respondents ((1,937 + 93) × 0.05 = 102) and total annual responses to CBER ((46,192 + 243) × 0.05 = 2,322).
Our estimated burden for the
information collection reflects an
overall increase of 739 hours and a
corresponding increase of 398
responses. We attribute this adjustment
to an increase in the number of
submissions we received over the last
few years.
Dated: December 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–27791 Filed 12–23–19; 8:45 am]
Comments on the ICR must be
received on or before January 27, 2020.
DATES:
Submit your comments to
OIRA_submission@omb.eop.gov or via
facsimile to (202) 395–5806.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0990–New–30D and project title for
reference.
BILLING CODE 4164–01–P
Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (1) The necessity and
utility of the proposed information
collection for the proper performance of
the agency’s functions; (2) the accuracy
of the estimated burden; (3) ways to
enhance the quality, utility, and clarity
of the information to be collected; and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Title of the Collection: Medical
Countermeasures.gov.
Type of Collection: OMB No. 0990–
0323—Extension—
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0323]
Agency Information Collection
Request; 30-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
SUMMARY:
Abstract: The Office of the Assistant
Secretary for Preparedness and
Response (ASPR), Office of the
Biomedical Advanced Research and
Development Authority (BARDA), is
requesting an approval on an extension
by OMB on a currently approved
information collection.
The purpose of this collection is, in
order to route product developers to the
most appropriate personnel within the
Department of Health and Human
Services (HHS), HHS collects some
basic information about the company’s
product through Medical
Countermeasures.gov. Using this
information and a routing system that
has been developed with input from
participating agencies within HHS,
including the Office of the Assistant
Secretary for Preparedness and
Response (ASPR), the Centers for
Disease Control and Prevention (CDC),
the Food and Drug Administration
(FDA), and the National Institutes of
Health (NIH), Medical
Countermeasures.gov routes the meeting
request to the appropriate person within
HHS. ASPR is requesting an extension
by OMB for a three-year clearance.
Type of respondent: Developers of
medical countermeasures to naturally
occurring and intentional public health
threats visit the site on a monthly basis.
khammond on DSKJM1Z7X2PROD with NOTICES
ANNUALIZED BURDEN HOUR TABLE
Number of
respondents
Number of
responses per
respondents
Average
burden per
response
Forms
(if necessary)
Respondents
(if necessary)
Meeting Request ............
Developers of medical countermeasures to naturally occurring and
intentional public health threats.
245
1
10/60
41
Total .........................
..............................................................................................................
........................
........................
........................
41
Terry Clark,
Office of the Secretary, Asst. Paperwork
Reduction Act Reports Clearance Officer.
[FR Doc. 2019–27753 Filed 12–23–19; 8:45 am]
BILLING CODE 4150–04–P
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Total burden
hours
]]>Agencies
[Federal Register Volume 84, Number 247 (Thursday, December 26, 2019)]
[Notices]
[Pages 70979-70981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27791]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0579]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Biological Products:
Reporting of Biological Product Deviations and Human Cells, Tissues,
and Cellular and Tissue-Based Deviations in Manufacturing
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 January
27, 2020.
[[Page 70980]]
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0458.
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.
Biological Products: Reporting of Biological Product Deviations and
Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations
in Manufacturing; Forms FDA 3486 and 3486A
OMB Control Number 0910-0458--Extension
Under section 351 of the Public Health Service Act (PHS Act) (42
U.S.C. 262), all biological products, including human blood and blood
components, offered for sale in interstate commerce must be licensed
and meet standards, including those prescribed in the FDA regulations,
designed to ensure the continued safety, purity, and potency of such
products. In addition, under section 361 of the PHS Act (42 U.S.C.
264), FDA may issue and enforce regulations necessary to prevent the
introduction, transmission, or spread of communicable diseases between
the States or possessions or from foreign countries into the States or
possessions. Further, the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 351) provides that drugs and devices (including human
blood and blood components) are adulterated if they do not conform with
current good manufacturing practice (CGMP) assuring that they meet the
requirements of the FD&C Act. Establishments manufacturing biological
products, including human blood and blood components, must comply with
the applicable CGMP regulations (parts 211, 606, and 820 (21 CFR parts
211, 606, and 820)) and current good tissue practice (CGTP) regulations
(part 1271 (21 CFR part 1271)) as appropriate. FDA regards biological
product deviation (BPD) reporting and HCT/P deviation reporting to be
an essential tool in its directive to protect public health by
establishing and maintaining surveillance programs that provide timely
and useful information.
Section 600.14 (21 CFR 600.14), in brief, requires the manufacturer
who holds the biological product license, for other than human blood
and blood components, and who had control over a distributed product
when the deviation occurred, to report to the Center for Biologics
Evaluation and Research (CBER) or to the Center for Drug Evaluation and
Research (CDER) as soon as possible but at a date not to exceed 45
calendar days after acquiring information reasonably suggesting that a
reportable event has occurred. Section 606.171, in brief, requires
licensed manufacturers of human blood and blood components, including
Source Plasma, unlicensed registered blood establishments, and
transfusion services, who had control over a distributed product when
the deviation occurred, to report to CBER as soon as possible but at a
date not to exceed 45 calendar days after acquiring information
reasonably suggesting that a reportable event has occurred. Similarly,
Sec. 1271.350(b), in brief, requires HCT/P establishments that
manufacture non-reproductive HCT/Ps described in Sec. 1271.10 to
investigate and report to CBER all HCT/P deviations relating to a
distributed HCT/P that relates to the core CGTP requirements, if the
deviation occurred in the establishment's facility or in a facility
that performed a manufacturing step for the establishment under
contract, agreement or other arrangement. Form FDA 3486 is used to
submit BPD reports and HCT/P deviation reports.
Respondents to this collection of information are: (1) Licensed
manufacturers of biological products other than human blood and blood
components, (2) licensed manufacturers of blood and blood components
including Source Plasma, (3) unlicensed registered blood
establishments, (4) transfusion services, and (5) establishments that
manufacture non-reproductive HCT/Ps regulated solely under section 361
of the PHS Act as described in Sec. 1271.10. The number of respondents
and total annual responses are based on the BPD reports and HCT/P
deviation reports FDA received in fiscal year 2018. The number of
licensed manufacturers and total annual responses under Sec. 600.14
include the estimates for BPD reports submitted to both CBER and CDER.
Based on the information from industry, the estimated average time to
complete a deviation report is 2 hours, which includes a minimal one-
time burden to create a user account for those reports submitted
electronically. The availability of the standardized report form, Form
FDA 3486, and the ability to submit this report electronically to CBER
(CDER does not currently accept electronic filings) further streamlines
the report submission process.
CBER has developed a Web-based addendum to Form FDA 3486 (Form FDA
3486A) to provide additional information when a BPD report has been
reviewed by FDA and evaluated as a possible recall. The additional
information requested includes information not contained in the Form
FDA 3486 such as: (1) Distribution pattern; (2) method of consignee
notification; (3) consignee(s) of products for further manufacture; (4)
additional product information; (5) updated product disposition; and
(6) industry recall contacts. This information is requested by CBER
through email notification to the submitter of the BPD report. This
information is used by CBER for recall classification purposes. CBER
estimates that 5 percent of the total BPD reports submitted to CBER
would need additional information submitted in the addendum. CBER
further estimates that it would take between 10 to 20 minutes to
complete the addendum. For calculation purposes, CBER is using 15
minutes.
Activities such as investigating, changing standard operating
procedures or processes, and followup are currently required under 21
CFR parts 211 (approved under OMB control number 0910-0139), 606
(approved under OMB control number 0910-0116), 820 (approved under OMB
control number 0910-0073), and 1271 (approved under OMB control number
0910-0543) and, therefore, are not included in the burden calculation
for the separate requirement of submitting a deviation report to FDA.
In the Federal Register of July 31, 2019 (84 FR 37321), we
published a 60-day notice requesting public comment on the proposed
collection of information. One comment offering general support for the
information collection was received.
We estimate the burden of this collection of information as
follows:
[[Page 70981]]
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section FDA form No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
600.14; Reporting of product deviations by licensed 3486 93 6.14 571 2.0 1,142
manufacturers..........................................
606.171; Reporting of product deviations by licensed 3486 1,937 23.847 46,192 2.0 92,384
manufacturers, unlicensed registered blood
establishments, and transfusion services...............
1271.350(b); Reporting requirements (human cells, 3486 93 2.61 243 2.0 486
tissues, and cellular and tissue-based products).......
1271.350(b) (CBER addendum report)...................... \2\ 3486A 102 22.76 2,322 0.25 580.5
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. 49,328 .............. 94,592.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Five percent of the number of respondents ((1,937 + 93) x 0.05 = 102) and total annual responses to CBER ((46,192 + 243) x 0.05 = 2,322).
Our estimated burden for the information collection reflects an
overall increase of 739 hours and a corresponding increase of 398
responses. We attribute this adjustment to an increase in the number of
submissions we received over the last few years.
Dated: December 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-27791 Filed 12-23-19; 8:45 am]
BILLING CODE 4164-01-P
