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, 70979-70981 [2019-27791]

Download as PDF Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / Notices provisions in 21 CFR part 601 are approved under OMB control number 0910–0338. III. Electronic Access Persons with access to the internet may obtain the draft guidance at either https://www.fda.gov/combinationproducts/guidance-regulatoryinformation/combination-productsguidance-documents or https:// www.regulations.gov. Dated: December 18, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–27799 Filed 12–23–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2019–N–0001] The Tobacco Products Scientific Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Tobacco Products Scientific Advisory Committee (TPSAC, the Committee). The general function of the Committee is to provide advice and recommendations to the Agency on FDA’s regulatory issues. The meeting will be open to the public. DATES: The meeting will be held on February 14, 2020, from 8:30 a.m. to 5 p.m. ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993– 0002. Answers to commonly asked questions including information regarding special accommodations due to a disability, visitor parking, and transportation may be accessed at: https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm408555.htm. For those unable to attend in person, the meeting will also be webcast and will be available at the following link: https://collaboration.fda.gov/ tpsac021420/. FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Office of Science, Center for Tobacco Products, Food and Drug Administration, Document Control Center, Bldg. 71, Rm. G335, 10903 New Hampshire Ave., khammond on DSKJM1Z7X2PROD with NOTICES SUMMARY: VerDate Sep<11>2014 16:53 Dec 23, 2019 Jkt 250001 Silver Spring, MD 20993–0002, 1–877– 287–1373, email: TPSAC@fda.hhs.gov, or FDA Advisory Committee Information Line, 1–800–741–8138 (301–443–0572 in the Washington, DC area). A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the Agency’s website at https://www.fda.gov/ AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee meeting link, or call the advisory committee information line to learn about possible modifications before coming to the meeting. SUPPLEMENTARY INFORMATION: Agenda: On February 14, 2020, the Center for Tobacco Product’s TPSAC will convene for one open session, during which the Committee will discuss the modified risk tobacco product applications, submitted by 22nd Century Group Inc. for the following combusted filtered cigarette tobacco products: • MR0000159: VLNTM King • MR0000160: VLNTM Menthol King FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its website prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s website after the meeting. Background material is available at https://www.fda.gov/ AdvisoryCommittees/Calendar/ default.htm. Scroll down to the appropriate advisory committee meeting link. Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before February 7, 2020. Oral presentations from the public will be scheduled between approximately10:45 a.m. and 11:45 a.m. on February 14, 2020. Those individuals interested in making formal oral presentations should notify the contact person (see FOR FURTHER INFORMATION CONTACT) and submit a brief statement describing the general nature of the evidence or arguments they wish to present and the names and email addresses of proposed participants on or before January 30, 2020, by 5 p.m. Eastern Time. Time allotted for each presentation may be limited. If the PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 70979 number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by January 31, 2020. Persons attending FDA’s advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with disabilities. If you require accommodations due to a disability, please contact Serina HunterThomas at least 7 days in advance of the meeting (see FOR FURTHER INFORMATION CONTACT). FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our website at https://www.fda.gov/Advisory Committees/AboutAdvisoryCommittees/ ucm111462.htm for procedures on public conduct during advisory committee meetings. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: December 19, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–27774 Filed 12–23–19; 8:45 am] BILLING CODE 4164–01–P 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 TissueBased Deviations in Manufacturing AGENCY: Food and Drug Administration, HHS. ACTION: Notice. 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. SUMMARY: E:\FR\FM\26DEN1.SGM 26DEN1 70980 Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / Notices 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. ADDRESSES: 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. In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUPPLEMENTARY INFORMATION: 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 khammond on DSKJM1Z7X2PROD with NOTICES 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 VerDate Sep<11>2014 16:53 Dec 23, 2019 Jkt 250001 (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, § 1271.350(b), in brief, requires HCT/P establishments that manufacture non-reproductive HCT/Ps described in § 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 nonreproductive HCT/Ps regulated solely under section 361 of the PHS Act as described in § 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 § 600.14 include the estimates for BPD reports submitted to PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 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 60day 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: E:\FR\FM\26DEN1.SGM 26DEN1 70981 Federal Register / Vol. 84, No. 247 / Thursday, December 26, 2019 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 21 CFR section 600.14; Reporting of product deviations by licensed manufacturers ...................................................................................... 606.171; Reporting of product deviations by licensed manufacturers, unlicensed registered blood establishments, and transfusion services ............................................................... 1271.350(b); Reporting requirements (human cells, tissues, and cellular and tissue-based products) ............................... 1271.350(b) (CBER addendum report) ..................................... Total ................................................................................... Number of responses per respondent Number of respondents FDA form No. Total annual responses Average burden per response Total hours 3486 93 6.14 571 2.0 1,142 3486 1,937 23.847 46,192 2.0 92,384 3486 2 3486A 93 102 2.61 22.76 243 2,322 2.0 0.25 486 580.5 ........................ ........................ ........................ 49,328 ........................ 94,592.5 1 There 2 Five are no capital costs or operating and maintenance costs associated with this collection of information. percent of the number of respondents ((1,937 + 93) × 0.05 = 102) and total annual responses to CBER ((46,192 + 243) × 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] Comments on the ICR must be received on or before January 27, 2020. DATES: Submit your comments to OIRA_submission@omb.eop.gov or via facsimile to (202) 395–5806. ADDRESSES: FOR FURTHER INFORMATION CONTACT: Sherrette Funn, Sherrette.Funn@hhs.gov or (202) 795–7714. When submitting comments or requesting information, please include the document identifier 0990–New–30D and project title for reference. BILLING CODE 4164–01–P Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the agency’s functions; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Title of the Collection: Medical Countermeasures.gov. Type of Collection: OMB No. 0990– 0323—Extension— SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND HUMAN SERVICES [Document Identifier: OS–0990–0323] Agency Information Collection Request; 30-Day Public Comment Request Office of the Secretary, HHS. Notice. AGENCY: ACTION: In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment. SUMMARY: Abstract: The Office of the Assistant Secretary for Preparedness and Response (ASPR), Office of the Biomedical Advanced Research and Development Authority (BARDA), is requesting an approval on an extension by OMB on a currently approved information collection. The purpose of this collection is, in order to route product developers to the most appropriate personnel within the Department of Health and Human Services (HHS), HHS collects some basic information about the company’s product through Medical Countermeasures.gov. Using this information and a routing system that has been developed with input from participating agencies within HHS, including the Office of the Assistant Secretary for Preparedness and Response (ASPR), the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA), and the National Institutes of Health (NIH), Medical Countermeasures.gov routes the meeting request to the appropriate person within HHS. ASPR is requesting an extension by OMB for a three-year clearance. Type of respondent: Developers of medical countermeasures to naturally occurring and intentional public health threats visit the site on a monthly basis. khammond on DSKJM1Z7X2PROD with NOTICES ANNUALIZED BURDEN HOUR TABLE Number of respondents Number of responses per respondents Average burden per response Forms (if necessary) Respondents (if necessary) Meeting Request ............ Developers of medical countermeasures to naturally occurring and intentional public health threats. 245 1 10/60 41 Total ......................... .............................................................................................................. ........................ ........................ ........................ 41 Terry Clark, Office of the Secretary, Asst. Paperwork Reduction Act Reports Clearance Officer. [FR Doc. 2019–27753 Filed 12–23–19; 8:45 am] BILLING CODE 4150–04–P VerDate Sep<11>2014 16:53 Dec 23, 2019 Jkt 250001 PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 E:\FR\FM\26DEN1.SGM 26DEN1 Total burden hours

Agencies

[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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 [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: 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, 
[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 (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\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                             Number of
                     21 CFR section                        FDA form No.      Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
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
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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