Document ID: FDA-2013-N-0579-0009
Agency: fda
Document Type: Notice
Title: 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 Deviations in Manufacturing
Posted Date: 2019-12-26T05:00Z

[Federal Register Volume 84, Number 247 (Thursday, December 26, 2019)]
[Notices]
[Pages 70979-70981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27791]

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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 Deviations in Manufacturing

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 
27, 2020.

[[Page 70980]]

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 oira_submission@omb.eop.gov. 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: Domini Bean, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-5733, 
PRAStaff@fda.hhs.gov.

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 (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 Drug 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 2018. 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. CBER 
estimates that 5 percent of the total BPD reports submitted to CBER 
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), 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 July 31, 2019 (84 FR 37321), we 
published a 60-day notice requesting public comment on the proposed 
collection of information. One comment offering general support for the 
information collection was received.
    We estimate the burden of this collection of information as 
follows:

[[Page 70981]]

                                                     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    Total hours
                                                                            respondents     respondent       responses     per response
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600.14; Reporting of product deviations by licensed                 3486              93            6.14             571             2.0           1,142
 manufacturers..........................................
606.171; Reporting of product deviations by licensed                3486           1,937          23.847          46,192             2.0          92,384
 manufacturers, unlicensed registered blood
 establishments, and transfusion services...............
1271.350(b); Reporting requirements (human cells,                   3486              93            2.61             243             2.0             486
 tissues, and cellular and tissue-based products).......
1271.350(b) (CBER addendum report)......................       \2\ 3486A             102           22.76           2,322            0.25           580.5
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............          49,328  ..............        94,592.5
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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 ((1,937 + 93) x 0.05 = 102) and total annual responses to CBER ((46,192 + 243) x 0.05 = 2,322).

    Our estimated burden for the information collection reflects an 
overall increase of 739 hours and a corresponding increase of 398 
responses. We attribute this adjustment to an increase in the number of 
submissions we received over the last few years.

    Dated: December 10, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-27791 Filed 12-23-19; 8:45 am]
 BILLING CODE 4164-01-P