Agency Information Collection Activities; Proposed Collection; Comment Request; Biological Products: Reporting of Biological Product Deviations and Human Cells, Tissues, and Cellular and Tissue-Based Product Deviations in Manufacturing; Form FDA 3486 and Addendum 3486A, 59556-59557 [E9-27716]
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59556
Federal Register / Vol. 74, No. 221 / Wednesday, November 18, 2009 / Notices
Dated: November 12, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–27719 Filed 11–17–09; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0545]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Biological
Products: Reporting of Biological
Product Deviations and Human Cells,
Tissues, and Cellular and TissueBased Product Deviations in
Manufacturing; Form FDA 3486 and
Addendum 3486A
AGENCY:
Food and Drug Administration,
HHS.
mstockstill on DSKH9S0YB1PROD with NOTICES
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 (BPDs) and human
cells, tissues, and cellular and tissuebased product (HCT/P) deviations, and
Form FDA 3486 and Addendum 3486A.
DATES: Submit written or electronic
comments on the collection of
information by January 19, 2010.
ADDRESSES: Submit electronic
comments on the collection of
information to: https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. All
comments should be identified with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management (HFA–710),
Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,
301–796–3792.
VerDate Nov<24>2008
16:30 Nov 17, 2009
Jkt 220001
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.
SUPPLEMENTARY INFORMATION:
Biological Products: Reporting of
Biological Product Deviations and
Human Cells, Tissues, and Cellular and
Tissue-Based Product Deviations; Form
FDA 3486 and Addendum 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
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
Cosmetic Act (the 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
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 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, 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 not to exceed 45
calendar days after acquiring
information reasonably suggesting that a
reportable event has occurred. Section
606.171, in brief, requires a licensed
manufacturer of human blood and blood
components, including Source Plasma;
an unlicensed registered blood
establishment; or a transfusion service
who had control over a distributed
product when the deviation occurred, to
report to CBER as soon as possible but
not to exceed 45 calendar days after
acquiring information reasonably
suggesting that a reportable event has
occurred. Similarly § 1271.350(b), in
brief, requires non-reproductive HCT/P
establishments described in § 1271.10 to
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 the licensed
manufacturers of biological products
other than human blood and blood
components, licensed manufacturers of
blood and blood components including
Source Plasma, unlicensed registered
blood establishments, transfusion
services, and establishments that
manufacture non-reproductive HCT/Ps
E:\FR\FM\18NON1.SGM
18NON1
59557
Federal Register / Vol. 74, No. 221 / Wednesday, November 18, 2009 / Notices
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 (FY) 2008. The
number of licensed manufacturers and
total annual responses under 21 CFR
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.
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 an addendum to
Form FDA 3486. The web-based
addendum 3486A provides 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 e-mail
notification to the submitter of the BPD
report. This information is used by
CBER for recall classification purposes.
At this time Addendum 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 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 follow-up are
currently required under 21 CFR 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 are
approved under OMB Control No. 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:
ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR
Section
FDA Form
Number
No. of
Respondents
Annual Frequency
per Response
Total Annual
Responses
Hours per
Response
Total Hours
600.14
3486
51
7.78
397
2.0
794
606.171
3486
1,533
28.78
44,125
2.0
88,250
1271.350(b)
3486
84
2.64
222
2.0
444
3486A2
77
28.65
2,206
0.25
551.5
Total
90,039.5
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 (1,533 x 0.05 = 77) and total annual responses to CBER (44,125 x 0.05 = 2,206).
Dated: November 12, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–27716 Filed 11–17–09; 8:45 am]
BILLING CODE 4160–01–S
5 CFR 1320.5 (General requirements)
Reporting and Recordkeeping
Requirements:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
mstockstill on DSKH9S0YB1PROD with NOTICES
Submission for OMB review; Comment
Request; Parental Knowledge,
Attitudes, and Behaviors Related to
Pediatric Cardiovascular Health
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Heart, Lung, and Blood Institute
(NHLBI), the National Institutes of
Health has submitted to the Office of
Management and Budget (OMB) a
request to review and approve the
information collection listed below.
This proposed information collection
was previously published in the Federal
Register on Wednesday, July 29, 2009,
VerDate Nov<24>2008
16:30 Nov 17, 2009
Jkt 220001
Volume 74, Number 144 and allowed
60-days for public comment. No public
comments were received. The purpose
of this notice is to allow an additional
30 days for public comment.
Final Rule requires that the agency
inform the potential persons who are to
respond to the collection of information
that such persons are not required to
respond to the collection of information
unless it displays a currently valid OMB
control number. This information is
required to be stated in the 30-day
Federal Register Notice.
Proposed Collection: Describe the
proposed information collection activity
as follows. Include: Title: Parental
Knowledge, Attitudes, and Behaviors
Related to Pediatric Cardiovascular
Health; Type of Information Collection
Request: New; Need and Use of
Information Collection: Coinciding with
the release of the Integrated Pediatric
Cardiovascular Risk Reduction
PO 00000
Frm 00038
Fmt 4703
Sfmt 4703
Guidelines, the National Heart, Lung,
and Blood Institute (NHLBI) will
conduct a national public awareness
campaign to help parents understand
that risk for cardiovascular disease
(CVD) begins in childhood, and to
engage them in encouraging healthy
habits in their children to promote heart
health and reduce their children’s CVD
risk now and as they grow. Currently,
little is known about parental
knowledge, attitudes, and behaviors
related to heart health in children.
Serving as a baseline for evaluation of
NHLBI’s outreach activities related to
the campaign, this study seeks to learn
the following: (a) Parents’ awareness of
cardiovascular disease risk factors in
children and knowledge of what to do
for risk reduction, (b) parents’ level of
efficacy toward taking action to promote
cardiovascular health and reduce risk
factors, and (c) parents’ behaviors
related to cardiovascular health. The
findings will provide valuable
information that will enable NHLBI to
identify the gaps in knowledge and
awareness and target specific
E:\FR\FM\18NON1.SGM
18NON1
]]>Agencies
[Federal Register Volume 74, Number 221 (Wednesday, November 18, 2009)]
[Notices]
[Pages 59556-59557]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-27716]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0545]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Biological Products: Reporting of Biological Product
Deviations and Human Cells, Tissues, and Cellular and Tissue-Based
Product Deviations in Manufacturing; Form FDA 3486 and Addendum 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
(BPDs) and human cells, tissues, and cellular and tissue-based product
(HCT/P) deviations, and Form FDA 3486 and Addendum 3486A.
DATES: Submit written or electronic comments on the collection of
information by January 19, 2010.
ADDRESSES: Submit electronic comments on the collection of information
to: https://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Elizabeth Berbakos, Office of
Information Management (HFA-710), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857, 301-796-3792.
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;
Form FDA 3486 and Addendum 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 (the
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 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 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, 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 not to exceed 45 calendar days after
acquiring information reasonably suggesting that a reportable event has
occurred. Section 606.171, in brief, requires a licensed manufacturer
of human blood and blood components, including Source Plasma; an
unlicensed registered blood establishment; or a transfusion service who
had control over a distributed product when the deviation occurred, to
report to CBER as soon as possible but 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
non-reproductive HCT/P establishments described in Sec. 1271.10 to
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 the licensed
manufacturers of biological products other than human blood and blood
components, licensed manufacturers of blood and blood components
including Source Plasma, unlicensed registered blood establishments,
transfusion services, and establishments that manufacture non-
reproductive HCT/Ps
[[Page 59557]]
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 (FY) 2008. The number of licensed manufacturers and total annual
responses under 21 CFR 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. 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 an addendum to Form FDA 3486. The web-based
addendum 3486A provides 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 e-mail notification to the submitter of the BPD report. This
information is used by CBER for recall classification purposes. At this
time Addendum 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 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 follow-up are currently required under 21
CFR 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 are approved under OMB
Control No. 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:
Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency per Total Annual Hours per
21 CFR Section FDA Form Number Respondents Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
600.14 3486 51 7.78 397 2.0 794
--------------------------------------------------------------------------------------------------------------------------------------------------------
606.171 3486 1,533 28.78 44,125 2.0 88,250
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.350(b) 3486 84 2.64 222 2.0 444
--------------------------------------------------------------------------------------------------------------------------------------------------------
3486A\2\ 77 28.65 2,206 0.25 551.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 90,039.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 (1,533 x 0.05 = 77) and total annual responses to CBER (44,125 x 0.05 = 2,206).
Dated: November 12, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9-27716 Filed 11-17-09; 8:45 am]
BILLING CODE 4160-01-S
