Document ID: FDA-2013-N-0579-0003
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 Deviations in Manufacturing; Forms FDA 3486 and 3486A
Posted Date: 2016-06-07T04:00Z

[Federal Register Volume 81, Number 109 (Tuesday, June 7, 2016)]
[Notices]
[Pages 36550-36552]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13366]

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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 
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 8, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your

[[Page 36551]]

comment does not include any confidential information that you or a 
third party may not wish to be posted, such as medical information, 
your or anyone else's Social Security number, or confidential business 
information, such as a manufacturing process. Please note that if you 
include your name, contact information, or other information that 
identifies you in the body of your comments, that information will be 
posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0579 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; Biological Products: Reporting of 
Biological Product Deviations and Human Cells, Tissues, and Cellular 
and Tissue-Based Deviations in Manufacturing; Forms FDA 3486 and 
3486A.'' Received comments will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, PRAStaff@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, section 501 of 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

[[Page 36552]]

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: (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 2015. 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 has 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, Form FDA 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 Form FDA 3486A. CBER further estimates that it 
would take between 10 to 20 minutes to complete Form FDA 3486A. For 
calculation purposes, CBER is using 15 minutes.
    Activities such as investigating, changing standard operating 
procedures or processes, and followup are currently required under 
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:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                               Number of
              21 CFR section                 FDA form No.      Number of     responses per   Total annual    Average burden per response    Total hours
                                                              respondents     respondent       responses
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600.14....................................            3486             102            5.99             611  2...........................           1,222
606.171...................................            3486           1,738           26.34          45,774  2...........................          91,548
1271.350(b)...............................            3486              97            2.64             256  2...........................             512
Web-based Addendum........................       \2\ 3486A              87           26.31           2,289  .25 (15 minutes)............             572
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    Total.................................  ..............  ..............  ..............  ..............  ............................          93,854
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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 (1,738 x 0.05 = 87) and total annual responses to CBER (45,774 x 0.05 = 2,289).

    Dated: May 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13366 Filed 6-6-16; 8:45 am]
 BILLING CODE 4164-01-P