[Federal Register Volume 78, Number 233 (Wednesday, December 4, 2013)]
[Notices]
[Pages 72893-72894]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-28990]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


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; 
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 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 January 
3, 2014.

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 emailed 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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, 
MD 20850, [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; 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 human cells, tissues and cellular and tissue-based products (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

[[Page 72894]]

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, and to 
report such HCT/P deviations within 45 days of the discovery of the 
event. Form FDA 3486 is used to submit BPD reports and HCT/P deviation 
reports.
    Respondents to this collection of information are (1) Licensed 
manufacturers of biological products other than human blood and blood 
components; (2) licensed manufacturers of blood and blood components 
including Source Plasma; (3) unlicensed registered blood 
establishments; (4) transfusion services; and (5) 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, which includes a minimal one-
time burden to create a user account for those reports submitted 
electronically. 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 developed a Web-based addendum to Form FDA 3486 (Form FDA 
3486A) to provide 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 part 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.
    In the Federal Register of June 5, 2013 (78 FR 33846), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                              Number of                       Average
                      21 CFR Section                        Form FDA No.      Number of     responses per   Total annual     burden per     Total hours
                                                                             respondents     respondent       responses       response
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600.14...................................................            3486              91            7.71             702           2.0            1,404
606.171..................................................            3486           1,679           32.73          54,947           2.0          109,894
1271.350(b)..............................................            3486              94            2.66             250           2.0              500
1271.350(b)..............................................       \2\ 3486A              84           32.70           2,747           0.25             687
                                                          ----------------------------------------------------------------------------------------------
    Total................................................                                                                                        112,485
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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 (54,947 x 0.05 = 2,747).


    Dated: November 27, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-28990 Filed 12-3-13; 8:45 am]
BILLING CODE 4160-01-P