[Federal Register Volume 75, Number 93 (Friday, May 14, 2010)]
[Notices]
[Pages 27347-27348]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-11541]


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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 [email protected]. 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, 
[email protected].

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