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 Product Deviations in Manufacturing; Form FDA 3486 and Addendum 3486A, 27347-27348 [2010-11541]
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Federal Register / Vol. 75, No. 93 / Friday, May 14, 2010 / Notices
Seleda Perryman,
Office of the Secretary, Paperwork Reduction
Act Reports Clearance Officer.
[FR Doc. 2010–11568 Filed 5–13–10; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0545]
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 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
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 June 14,
2010.
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 e-mailed 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.
emcdonald on DSK2BSOYB1PROD with NOTICES
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Elizabeth Berbakos, Office of
Information Management, Food and
Drug Administration, 1350 Piccard Dr.,
PI50–400B, Rockville, MD 20850, 301–
796–3792,
Elizabeth.Berbakos@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:
VerDate Mar<15>2010
18:07 May 13, 2010
Jkt 220001
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—(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
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, 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
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
27347
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
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
E:\FR\FM\14MYN1.SGM
14MYN1
27348
Federal Register / Vol. 75, No. 93 / Friday, May 14, 2010 / Notices
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 and 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), 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 November
18, 2009 (74 FR 59556), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received on the information collection.
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
21 CFR
Section
FDA
Form No.
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
44,120
2.0
88,240
1271.350(b)
3486
84
2.64
222
2.0
444
3486A2
77
28.65
2,206
0.25
551.5
Total
90,029.5
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 (1,533 x 0.05 = 77) and total annual responses to CBER (44,125 x 0.05 = 2,206).
Dated: May 10, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
Directive 21 to share stockpiled assets
with other federal government
organizations when the material will be
replaced by the receiving organization.
This delegation became effective upon
date of signature. I hereby affirm and
ratify any actions taken by the Director,
OPHPR, which involve the exercise of
these authorities prior to the effective
date of this delegation.
[FR Doc. 2010–11541 Filed 5–13–10; 8:45 am]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
emcdonald on DSK2BSOYB1PROD with NOTICES
Public Health Services Act; Delegation
of Authority
Notice is hereby given that I have
delegated to the Director, Office of
Public Health Preparedness and
Response (OPHPR), with authority to
redelegate, the authority to:
• Release small quantities of any
material from the Strategic National
Stockpile (SNS) to provide intervention
for specific individual conditions and
the coordination of transportation assets
to meet required deadlines.
• Release small quantities of any
material from the SNS for testing and
evaluation or to support governmentrequired programs of vaccinations for
persons at risk for specific conditions as
a result of government job requirements.
• Advance deploy any material from
the SNS to remain under CDC control
without release to other government or
non-government organizations in order
to prepare for possible response needs
• Release any material from the SNS
to comply with requirements as set forth
by Homeland Security Presidential
VerDate Mar<15>2010
18:07 May 13, 2010
Jkt 220001
Dated: April 26, 2010.
Thomas Frieden,
Director, CDC.
[FR Doc. 2010–11406 Filed 5–13–10; 8:45 am]
BILLING CODE 4160–18–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Substance Abuse and Mental Health
Services Administration
Current List of Laboratories Which
Meet Minimum Standards To Engage in
Urine Drug Testing for Federal
Agencies
AGENCY: Substance Abuse and Mental
Health Services Administration, HHS.
ACTION: Notice.
SUMMARY: The Department of Health and
Human Services (HHS) notifies Federal
agencies of the laboratories currently
certified to meet the standards of
Subpart C of the Mandatory Guidelines
for Federal Workplace Drug Testing
Programs (Mandatory Guidelines). The
Mandatory Guidelines were first
published in the Federal Register on
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
April 11, 1988 (53 FR 11970), and
subsequently revised in the Federal
Register on June 9, 1994 (59 FR 29908),
on September 30, 1997 (62 FR 51118),
and on April 13, 2004 (69 FR 19644).
A notice listing all currently certified
laboratories is published in the Federal
Register during the first week of each
month. If any laboratory’s certification
is suspended or revoked, the laboratory
will be omitted from subsequent lists
until such time as it is restored to full
certification under the Mandatory
Guidelines.
If any laboratory has withdrawn from
the HHS National Laboratory
Certification Program (NLCP) during the
past month, it will be listed at the end,
and will be omitted from the monthly
listing thereafter.
This notice is also available on the
Internet at https://
www.workplace.samhsa.gov and https://
www.drugfreeworkplace.gov.
FOR FURTHER INFORMATION CONTACT: Mrs.
Giselle Hersh, Division of Workplace
Programs, SAMHSA/CSAP, Room 2–
1042, One Choke Cherry Road,
Rockville, Maryland 20857; 240–276–
2600 (voice), 240–276–2610 (fax).
SUPPLEMENTARY INFORMATION: The
Mandatory Guidelines were developed
in accordance with Executive Order
12564 and section 503 of Pub. L. 100–
71. Subpart C of the Mandatory
Guidelines, ‘‘Certification of
Laboratories Engaged in Urine Drug
Testing for Federal Agencies,’’ sets strict
standards that laboratories must meet in
order to conduct drug and specimen
E:\FR\FM\14MYN1.SGM
14MYN1
]]>Agencies
[Federal Register Volume 75, Number 93 (Friday, May 14, 2010)]
[Notices]
[Pages 27347-27348]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-11541]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2009-N-0545]
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 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 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 June
14, 2010.
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 e-mailed 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: Elizabeth Berbakos, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-3792,
Elizabeth.Berbakos@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; 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 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, 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 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
[[Page 27348]]
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 and 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), 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 November 18, 2009 (74 FR 59556), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received on the information
collection.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual Hours per
21 CFR Section FDA Form No. Respondents per Response Responses Response Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
600.14 3486 51 7.78 397 2.0 794
--------------------------------------------------------------------------------------------------------------------------------------------------------
606.171 3486 1,533 28.78 44,120 2.0 88,240
--------------------------------------------------------------------------------------------------------------------------------------------------------
1271.350(b) 3486 84 2.64 222 2.0 444
--------------------------------------------------------------------------------------------------------------------------------------------------------
3486A\2\ 77 28.65 2,206 0.25 551.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total 90,029.5
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: May 10, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-11541 Filed 5-13-10; 8:45 am]
BILLING CODE 4160-01-S
