
[Federal Register: May 14, 2010 (Volume 75, Number 93)]
[Notices]
[Page 27347-27348]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14my10-88]

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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.

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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\
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                                                                No. of        Annual Frequency     Total Annual        Hours per
           21 CFR  Section               FDA  Form No.       Respondents        per Response        Responses           Response          Total Hours
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600.14                                              3486                 51               7.78                397               2.0                794
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606.171                                             3486              1,533              28.78             44,120               2.0             88,240
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1271.350(b)                                         3486                 84               2.64                222               2.0                444
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                                                3486A\2\                 77              28.65              2,206               0.25               551.5
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Total                                                                                                                                           90,029.5
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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 (1,533 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

