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, 79504-79506 [2016-27259]
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79504
Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. FDA is issuing this final
guidance subject to OMB approval of
the collection of information. Before the
Agency begins collecting information
for the VQIP program, FDA will publish
a notice in the Federal Register
announcing OMB’s decision to approve,
modify, or disapprove the information
collection provisions in the guidance.
The guidance also refers to previously
approved collections of information
found in FDA regulations. The
collections of information regarding
food labeling have been approved under
OMB control number 0910–0381; the
collections of information regarding
Low Acid Canned Food have been
approved under OMB control number
0910–0037; the collections of
information regarding Third-Party
Certification Bodies to Conduct Food
Safety Audits and to Issue Certifications
have been approved under OMB control
number 0910–0750; the collections of
information regarding Current Good
Manufacturing Practice and Hazard
Analysis and Risk-Based Preventive
Controls for Human Food have been
approved under OMB control number
0910–0751; the collections of
information regarding Current Good
Manufacturing Practice and Hazard
Analysis and Risk-Based Preventive
Controls for Food for Animals have been
approved under OMB control number
0910–0789; the collections of
information regarding the Foreign
Supplier Verification Program have
been approved under OMB control
number 0910–0752; the collections of
information regarding the Sanitary
Transportation of Human and Animal
Food have been approved under OMB
control number 0910–0773; and the
collections of information regarding
Focused Mitigation Strategies to Protect
Food Against Intentional Adulteration
have been approved under OMB control
number 0910–0812.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/RegulatoryInformation/
Guidances or https://
www.regulations.gov. Use the FDA Web
site listed in the previous sentence to
find the most current version of the
guidance.
IV. Other Issues for Consideration
FSMA directs FDA to collect user fees
to fund VQIP. Consistent with section
743(b)(2)(B)(iii) of the FD&C Act, we set
forth a proposed set of guidelines in
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consideration of the burden of user fee
amounts on small businesses in the
Federal Register of June 5, 2015 (80 FR
32136), which also announced the draft
guidance for industry on VQIP. We are
considering comments we received on
the VQIP user fee. We will publish the
actual fee in a Federal Register notice
in accordance with section 743(b)(1) of
the FD&C Act prior to the fiscal year
when we begin program benefits.
SUPPLEMENTARY INFORMATION:
Dated: November 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
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 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 (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 human cells, tissues, and
cellular and tissue-based product (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
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
[FR Doc. 2016–27252 Filed 11–10–16; 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 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
(the PRA).
DATES: Fax written comments on the
collection of information by December
14, 2016.
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 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.
SUMMARY:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
St., North Bethesda, MD 20852,
PRAStaff@fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
PO 00000
Frm 00094
Fmt 4703
Sfmt 4703
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.
E:\FR\FM\14NON1.SGM
14NON1
Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices
reportable event has occurred. Section
606.171 (21 CFR 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) (21 CFR
1271.350(b)), in brief, requires HCT/P
establishments that manufacture nonreproductive 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 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,
79505
therefore, are not included in the
burden calculation for the separate
requirement of submitting a deviation
report to FDA.
In the Federal Register of June 7, 2016
(81 FR 36550), we published a 60-day
notice requesting public comment on
the proposed extension of this
collection of information. One comment
was submitted in response to the notice
concerning potential ways to minimize
the burden associated with the
information collection. The commenter
encouraged FDA to permit the use of
attachments to Forms FDA 3486 and
3486A when reporting multiple
biological product deviations from a
single starting source rather than retype
the information. The comment
suggested, alternatively, that
respondents’ burden might be reduced
by ‘‘capping the forms at a much lower
number of products/lots than the
current maximum of 100.’’ Finally, the
comment suggested Forms FDA 3486
and 3486A incorporate technology that
would permit barcode scanning for
relevant fields.
FDA is appreciative of this feedback.
At this time, however, we are unable to
make the suggested revisions to the
information collection. Currently,
product information can readily be
imported from a Microsoft Excel file (in
XLS format) into the eBPD report
without having to be retyped (up to 100
units/lots). In addition, the product
information entered on Form FDA 3486
automatically populates Form FDA
3486A minimizing the need to manually
reenter required information. While we
will consider future enhancements that
allow for attachments and integrate
barcode or other technologies that
facilitate or otherwise improve
reporting, we must ensure that upgrades
are compatible with our existing system.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATE ANNUAL REPORTING BURDEN 1
mstockstill on DSK3G9T082PROD with NOTICES
21 CFR section; activity
FDA Form No.
600.14; Reporting of BPDs by licensed manufacturers.
606.171; Reporting of product deviations by licensed manufacturers, unlicensed registered
blood
establishments,
and
transfusion services.
1271.350(b); HCT/P deviations ...
Web-based Addendum ................
Total ......................................
Number of
respondents
Number of
responses per
respondent
Total annual
responses
Average burden per
response
3486
102
5.99
611
2 ................................
1,222
3486
1,738
26.34
45,774
2 ................................
91,548
3486
2 3486A
97
87
2.64
26.31
256
2,289
2 ................................
0.25 (15 minutes) ......
512
572
........................
........................
........................
........................
....................................
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).
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79506
Federal Register / Vol. 81, No. 219 / Monday, November 14, 2016 / Notices
Dated: November 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–27259 Filed 11–10–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request; National Hospital
Organ Donation Campaign Activity
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects (Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995),
HRSA announces plans to submit an
Information Collection Request (ICR),
described below, to the Office of
Management and Budget (OMB). Prior
to submitting the ICR to OMB, HRSA
seeks comments from the public
regarding the burden estimate, below, or
any other aspect of the ICR.
DATES: Comments on this ICR must be
received no later than January 13, 2017.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N–39, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call the HRSA Information Collection
Clearance Officer at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
SUMMARY:
Information Collection Request Title:
National Hospital Organ Donation
Campaign Activity Scorecard OMB No.
0915–0373, Revision
Abstract: HRSA’s Hospital Campaign,
a special initiative of the Workplace
Partnership for Life program, enlists the
help of hospitals nationwide to increase
the number of registered organ, eye, and
tissue donors by hosting education and
registry events in their hospitals and
communities. The Activity Scorecard
provides activity ideas to participating
hospitals and assigns points to each
activity. Hospitals that earn a certain
number of points annually are
recognized by HRSA and the campaign’s
national partners.
Need and Proposed Use of the
Information: There is a substantial
imbalance in the U.S. between the
number of people whose life depends
on an organ transplant (currently about
120,000) and the annual number of
organ donors (approximately 14,000
living and deceased donors). In
response to the need for increased
donation, HRSA conducts public
outreach initiatives to encourage the
American public to enroll in their state
donor registry as future organ donors.
As part of this initiative, HRSA supports
this National Hospital Organ Donation
Campaign to involve hospitals
throughout the nation as partners in the
national effort to educate their staff and
communities about the urgent need for
donors and encourage donor registry
enrollments.
The activity scorecard serves two key
campaign functions: (1) It motivates and
facilitates hospitals’ participation in this
campaign, and (2) it provides the basis
for rewarding hospitals for their
accomplishments. In providing more
than 40 actionable donation promotion
strategies hospitals can choose to
implement, it eases the process of
planning and participation for hospital
teams. In addition, by attaching point
levels to each activity, HRSA uses the
information collected to recognize
hospital achievements at bronze, silver,
gold, and platinum point equivalents
and provides certificates for all
hospitals achieving any recognition
level.
A list of recognized hospitals is
shared with all campaign participants
during monthly webinars, in campaign
e-newsletters, and in communication
pieces sent out by the campaign’s
national partners, which include the
American Hospital Association and the
American Society of Transplantation. In
addition, local donation organizations
and participating state hospital
associations use the results to pay
tribute to HRSA-recognized hospitals in
their local service areas. The
information collected also helps HRSA
identify best practices that are then
shared with all hospital partners on the
monthly webinars. This version of the
scorecard contains two new
opportunities for hospitals to earn
points: A point is awarded for each
donor registration a hospital motivates
and points are awarded for reaching the
hospital’s donor registration goal.
Likely Respondents: Hospital
development and public relations staff
of organ procurement and other
donation organizations, hospital staff
such as nurses or public relations/
communications professionals, and
volunteers that work with the hospitals
on organ donation initiatives.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this Information
Collection Request are summarized in
the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
mstockstill on DSK3G9T082PROD with NOTICES
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
Activity Scorecard (electronic PDF) .....................................
1,000
1
1,000
.125
125
Total ..............................................................................
1,000
........................
1,000
........................
125
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]]>Agencies
[Federal Register Volume 81, Number 219 (Monday, November 14, 2016)]
[Notices]
[Pages 79504-79506]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-27259]
-----------------------------------------------------------------------
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 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 (the PRA).
DATES: Fax written comments on the collection of information by
December 14, 2016.
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 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.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, MD 20852, 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.
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 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
(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 human cells,
tissues, and cellular and tissue-based product (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 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
[[Page 79505]]
reportable event has occurred. Section 606.171 (21 CFR 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) (21 CFR 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 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 June 7, 2016 (81 FR 36550), we published
a 60-day notice requesting public comment on the proposed extension of
this collection of information. One comment was submitted in response
to the notice concerning potential ways to minimize the burden
associated with the information collection. The commenter encouraged
FDA to permit the use of attachments to Forms FDA 3486 and 3486A when
reporting multiple biological product deviations from a single starting
source rather than retype the information. The comment suggested,
alternatively, that respondents' burden might be reduced by ``capping
the forms at a much lower number of products/lots than the current
maximum of 100.'' Finally, the comment suggested Forms FDA 3486 and
3486A incorporate technology that would permit barcode scanning for
relevant fields.
FDA is appreciative of this feedback. At this time, however, we are
unable to make the suggested revisions to the information collection.
Currently, product information can readily be imported from a Microsoft
Excel file (in XLS format) into the eBPD report without having to be
retyped (up to 100 units/lots). In addition, the product information
entered on Form FDA 3486 automatically populates Form FDA 3486A
minimizing the need to manually reenter required information. While we
will consider future enhancements that allow for attachments and
integrate barcode or other technologies that facilitate or otherwise
improve reporting, we must ensure that upgrades are compatible with our
existing system.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimate Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section; activity FDA Form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
600.14; Reporting of BPDs by 3486 102 5.99 611 2................................. 1,222
licensed manufacturers.
606.171; Reporting of product 3486 1,738 26.34 45,774 2................................. 91,548
deviations by licensed
manufacturers, unlicensed
registered blood establishments,
and transfusion services.
1271.350(b); HCT/P deviations....... 3486 97 2.64 256 2................................. 512
Web-based Addendum.................. \2\ 3486A 87 26.31 2,289 0.25 (15 minutes)................. 572
---------------------------------------------------------------- ---------------
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).
[[Page 79506]]
Dated: November 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-27259 Filed 11-10-16; 8:45 am]
BILLING CODE 4164-01-P
