Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Deviations in Manufacturing; Forms FDA 3486 and 3486A, 36550-36552 [2016-13366]
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36550
Federal Register / Vol. 81, No. 109 / Tuesday, June 7, 2016 / Notices
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Refugee Microenterprise Development ...........................................................
Refugee Home-Based Child Care Microenterprise Development ...................
Total Burden .............................................................................................
22
23
........................
8
7
........................
4
4
........................
Estimated Total Annual Burden
Hours: (1340 hours x $30 per hour)
$40,440 per year.
Explanation
asabaliauskas on DSK3SPTVN1PROD with NOTICES
The Refugee Microenterprise
Development Program
• Currently, there are twenty two
grantees (respondents) in the program
and the semi-annual progress, which
includes the data and information
required, is submitted twice per year.
• The request covers one form (Form
I. attached) which includes eight data
points. Based on experience (the
information was provided by technical
assistance service provider in the past),
it takes about two hours per respondent
per six months (i.e., four hours per year
per grantee (respondent) or 88 hours per
year for all respondents) to complete the
form.
• No survey will be undertaken since
the collection of this data (information)
is part of the implementation process of
the project and its collection and
reporting does not constitute a separate
and additional cost to the grantees
(respondents). The cost is covered by
the grant the grantee receives. The
grantees have Down Home database
which captures and stores the data
required for reporting. The grantee
uploads the semi-annual report in Grant
Solution where it is stored. ORR derives
the data it requires for reporting and
management decision from Grant
Solution.
The Refugee Home-Based Child Care
Microenterprise Development Group
• Currently, there are twenty three
grantees (respondents) in the program
and the semi-annual progress.
• The request covers one form (Form
II. attached) which includes seven data
points. It takes about two hours per
respondent per six months (i.e., four
hours per year grantee (respondent) or
92 hours per year for all respondents) to
complete the form.
• The collection of this data
(information) is part of the process and
its collection and reporting does not
include separate and additional cost to
the grantees (respondents). The cost is
covered by the grant the grantee
receives. The grantees have database
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which captures and stores the data
required for reporting. The grantee
uploads the data required in Grant
Solution where it is stored. ORR derives
the data it requires for reporting and
management decision from Grant
Solution.
Additional Information
Copies of the proposed collection may
be obtained by writing to the
Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment
OMB is required to make a decision
concerning the collection of information
between 30 and 60 days after
publication of this document in the
Federal Register. Therefore, a comment
is best assured of having its full effect
if OMB receives it within 30 days of
publication. Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016–13401 Filed 6–6–16; 8:45 am]
BILLING CODE 4184–01–P
PO 00000
Total burden
hours
704
644
1340
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0579]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Biological
Products: Reporting of Biological
Product Deviations and Human Cells,
Tissues, and Cellular and TissueBased Deviations in Manufacturing;
Forms FDA 3486 and 3486A
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. 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 of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the information collection requirements
relating to the reporting of biological
product deviations in manufacturing
and human cells, tissues, and cellular
and tissue-based product (HCT/P)
deviations, and Forms FDA 3486 and
3486A.
DATES: Submit electronic or written
comments on the collection of
information by August 8, 2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
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Federal Register / Vol. 81, No. 109 / Tuesday, June 7, 2016 / Notices
asabaliauskas on DSK3SPTVN1PROD with NOTICES
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–N–0579 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Biological Products: Reporting of
Biological Product Deviations and
Human Cells, Tissues, and Cellular and
Tissue-Based Deviations in
Manufacturing; Forms FDA 3486 and
3486A.’’ Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
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claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3520), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
PO 00000
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36551
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
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, section 501 of the Federal
Food, Drug, and Cosmetic Act (the
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
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36552
Federal Register / Vol. 81, No. 109 / Tuesday, June 7, 2016 / Notices
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
Drugs 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 2015. The number of licensed
manufacturers and total annual
responses under § 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.
At this time, Form FDA 3486A is being
used only for those BPD reports
submitted under § 606.171. CBER
estimates that 5 percent of the total BPD
reports submitted to CBER under
§ 606.171 would need additional
information submitted in Form FDA
3486A. CBER further estimates that it
would take between 10 to 20 minutes to
complete Form FDA 3486A. For
calculation purposes, CBER is using 15
minutes.
Activities such as investigating,
changing standard operating procedures
or processes, and followup are currently
required under parts 211 (approved
under OMB control number 0910–0139),
part 606 (approved under OMB control
number 0910–0116), part 820 (approved
under OMB control number 0910–0073),
and part 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
FDA
form No.
21 CFR section
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden
per response
Total
hours
600.14 ..........................................
606.171 ........................................
1271.350(b) ..................................
Web-based Addendum ................
3486
3486
3486
2 3486A
102
1,738
97
87
5.99
26.34
2.64
26.31
611
45,774
256
2,289
2 ................................
2 ................................
2 ................................
.25 (15 minutes) ........
1,222
91,548
512
572
Total ......................................
........................
........................
........................
........................
....................................
93,854
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 (1,738 × 0.05 = 87) and total annual responses to CBER (45,774 × 0.05 = 2,289).
Dated: May 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
asabaliauskas on DSK3SPTVN1PROD with NOTICES
[FR Doc. 2016–13366 Filed 6–6–16; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Mental Health;
Notice of Closed Meetings
BILLING CODE 4164–01–P
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
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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 of
Mental Health Special Emphasis Panel Pilot
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]]>Agencies
[Federal Register Volume 81, Number 109 (Tuesday, June 7, 2016)]
[Notices]
[Pages 36550-36552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13366]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0579]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Biological Products: Reporting of Biological Product
Deviations and Human Cells, Tissues, and Cellular and Tissue-Based
Deviations in Manufacturing; Forms FDA 3486 and 3486A
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. 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 of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
requirements relating to the reporting of biological product deviations
in manufacturing and human cells, tissues, and cellular and tissue-
based product (HCT/P) deviations, and Forms FDA 3486 and 3486A.
DATES: Submit electronic or written comments on the collection of
information by August 8, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your
[[Page 36551]]
comment does not include any confidential information that you or a
third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your comments, that information will be
posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-N-0579 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Biological Products: Reporting of
Biological Product Deviations and Human Cells, Tissues, and Cellular
and Tissue-Based Deviations in Manufacturing; Forms FDA 3486 and
3486A.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
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, section 501 of the Federal Food, Drug, and
Cosmetic Act (the 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
[[Page 36552]]
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 Drugs 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 2015. 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. At this
time, Form FDA 3486A is being used only for those BPD reports submitted
under Sec. 606.171. CBER estimates that 5 percent of the total BPD
reports submitted to CBER under Sec. 606.171 would need additional
information submitted in Form FDA 3486A. CBER further estimates that it
would take between 10 to 20 minutes to complete Form FDA 3486A. For
calculation purposes, CBER is using 15 minutes.
Activities such as investigating, changing standard operating
procedures or processes, and followup are currently required under
parts 211 (approved under OMB control number 0910-0139), part 606
(approved under OMB control number 0910-0116), part 820 (approved under
OMB control number 0910-0073), and part 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
21 CFR section FDA form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
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600.14.................................... 3486 102 5.99 611 2........................... 1,222
606.171................................... 3486 1,738 26.34 45,774 2........................... 91,548
1271.350(b)............................... 3486 97 2.64 256 2........................... 512
Web-based Addendum........................ \2\ 3486A 87 26.31 2,289 .25 (15 minutes)............ 572
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Total................................. .............. .............. .............. .............. ............................ 93,854
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\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 (1,738 x 0.05 = 87) and total annual responses to CBER (45,774 x 0.05 = 2,289).
Dated: May 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13366 Filed 6-6-16; 8:45 am]
BILLING CODE 4164-01-P
