Document ID: FDA-2013-N-0579-0001
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; Forms FDA 3486 and 3486A
Posted Date: 2013-06-05T04:00Z

[Federal Register Volume 78, Number 108 (Wednesday, June 5, 2013)]
[Notices]
[Pages 33846-33847]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-13279]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0579]

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; Forms FDA 3486 and 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 
in manufacturing and human cells, tissues, and cellular and tissue-
based product (HCT/P) deviations, and Forms FDA 3486 and 3486A.

DATES: Submit electronic or written comments on the collection of 
information by August 5, 2013.

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: Ila Mizrachi, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, 
Rockville, MD 20850, 301-796-7726, Ila.Mizrachi@fda.hhs.gov.

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 
in Manufacturing; Forms FDA 3486 and 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 
FD&C 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 FD&C 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 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 (21 CFR 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 at a date not to exceed 45 
calendar days after acquiring information reasonably suggesting that a 
reportable event has occurred. Section 606.171, in brief, requires 
licensed manufacturers of human blood and blood components, including 
Source Plasma, unlicensed registered blood establishments, and 
transfusion services, who had control over a distributed product when 
the deviation occurred, to report to CBER as soon as possible but at a 
date 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 HCT/P establishments that 
manufacture non-reproductive HCT/Ps described in Sec.  1271.10 to 
investigate and 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

[[Page 33847]]

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 2012. The number of licensed 
manufacturers and total annual responses under Sec.  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 (Form FDA 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 email 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 followup 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 (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.
    FDA estimates the burden of this collection of information as 
follows:

                                                          Estimated Annual Reporting Burden\1\
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                                                                                             Number of
                     21 CFR section                        Form FDA No.      Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
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600.14..................................................            3486              91            7.71             702            2.0            1,404
606.171.................................................            3486           1,679           32.73          54,954            2.0          109,908
1271.350(b).............................................            3486              94            2.66             250            2.0              500
                                                               \2\ 3486A              84           32.70           2,747            0.25             687
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............         112,499
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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 (1,679 x 0.05 = 84) and total annual responses to CBER (54,954 x 0.05 = 2,748).

    Dated: May 30, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-13279 Filed 6-4-13; 8:45 am]
BILLING CODE 4160-01-P