Document ID: FDA-2009-N-0545-0001
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2009-11-18T05:00Z

[Federal Register: November 18, 2009 (Volume 74, Number 221)]
[Notices]               
[Page 59556-59557]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18no09-57]                         

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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.

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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: http://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\
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                                                                No. of       Annual Frequency  per   Total Annual      Hours per
          21 CFR Section               FDA Form  Number       Respondents           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          44,125            2.0               88,250
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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                                                                                                                                           90,039.5
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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: 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