Federal Register / Vol. 87, No. 117 / Friday, June 17, 2022 / Notices 36507 

Jeffrey M. Zirger, 

Lead, Information Collection Review Office, 

Office of Scientific Integrity, Office of Science, 

Centers for Disease Control and Prevention. 

[FR Doc. 2022–13091 Filed 6–16–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

CDC Town Hall Meeting on Laboratory 

Biosafety—Use of Laboratory 

Instruments 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice of meeting. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), located 

within the Department of Health and 

Human Services (HHS), announces a 

meeting regarding biosafety and 

laboratory instrumentation. 

DATES: The meeting will be held on 

Friday, June 24, 2022, from 10 a.m. to 

3:30 p.m., EDT. 

ADDRESSES: This meeting is open to the 

public through a virtual format, limited 

only by the webcast lines available. 

Registration is not required. Visit the 

CDC Safe Labs website for the meeting 

webcast at https://www.cdc.gov/ 

safelabs/biosafety-townhall.html. 

FOR FURTHER INFORMATION CONTACT: 

Nancy E. Cornish M.D., Center for 

Surveillance, Epidemiology and 

Laboratory Services, Centers for Disease 

Control and Prevention, 1600 Clifton 

Road NE, Mailstop V24–3, Atlanta, 

Georgia 30329–4018; Phone: (404)498– 

2720; Email: dlsbiosafety@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Purpose: The purpose of this meeting 

is to provide an overview and 

discussion on laboratory biosafety when 

using laboratory instruments to test 

human and biologic specimens. Meeting 

topics are listed in the ‘‘Matters to be 

Considered’’ section of this notice. 

Matters to be Considered: The agenda 

will include presentations and 

discussions on four topic areas: (1) 

instrument design and incorporating 

biosafety; (2) perceived risks to 

laboratory personnel and impact on 

testing; (3) independent assessment of 

risks and instrument design; and (4) a 

discussion of potential areas of 

collaboration to address issues 

discussed during the meeting. There 

will be prepared presentations, 

discussions among presenters and 

panelists, and a period for questions and 

public comments. Agenda items are 

subject to change as priorities dictate. 

Background: CDC’s Division of 

Laboratory Systems is hosting the town 

hall meeting in collaboration with 

clinical and public health laboratory 

partners, and instrument manufacturers 

to address clinical laboratory biosafety. 

The recent publication Clinical 

Laboratory Biosafety Gaps: Lessons 

Learned from Past Outbreaks Reveal a 

Path to a Safer Future (Cornish NE. et. 

al. Clinical Laboratory Biosafety Gaps: 

Lessons Learned from Past Outbreaks 

Reveal a Path to a Safer Future. Clin 

Microbiol Rev. July 2021, Vol. 34/3 

e00126–18) discussed critical gaps in 

clinical laboratory biosafety, including 

issues related to the use and 

disinfection of laboratory instruments. 

The discussion and feedback generated 

during the meeting will assist in 

evaluating current biosafety guidance 

and identify opportunities for 

improvement in clinical laboratory 

biosafety and use of laboratory 

instrumentation. This meeting is a 

listening session. Participants may 

provide individual advice or 

perspectives. CDC is not seeking 

consensus advice or recommendations 

from participants. 

Dated: June 14, 2022. 

Angela K. Oliver, 

Executive Secretary, Centers for Disease 

Control and Prevention. 

[FR Doc. 2022–13123 Filed 6–16–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–0030] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Human Drug 

Compounding Under Sections 503A 

and 503B of the Federal Food, Drug, 

and Cosmetic Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA, Agency, or we) is 

announcing an opportunity for public 

comment on the proposed collection of 

certain information by the Agency. 

Under the Paperwork Reduction Act of 

1995 (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 electronic 

reporting for outsourcing facilities. 

DATES: Submit either electronic or 

written comments on the collection of 

information by August 16, 2022. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. The https://

www.regulations.gov electronic filing 

system will accept comments until 

11:59 p.m. Eastern Time at the end of 

August 16, 2022. Comments received by 

mail/hand delivery/courier (for written/ 

paper submissions) will be considered 

timely if they are postmarked or the 

delivery service acceptance receipt is on 

or before that date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

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 

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 https://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): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, 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.’’ 


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36508 Federal Register / Vol. 87, No. 117 / Friday, June 17, 2022 / Notices 

Instructions: All submissions received 

must include the Docket No. FDA– 

2015–N–0030 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; Human 

Drug Compounding Under Sections 

503A and 503B of the Federal Food, 

Drug, and Cosmetic Act.’’ Received 

comments, those filed in a timely 

manner (see ADDRESSES), will be placed 

in the docket and, except for those 

submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff between 9 

a.m. and 4 p.m., Monday through 

Friday, 240–402–7500. 

• 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 

https://www.regulations.gov. Submit 

both copies to the Dockets Management 

Staff. 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: https://

www.govinfo.gov/content/pkg/FR-2015- 

09-18/pdf/2015-23389.pdf. 

Docket: For access to the docket to 

read background documents or the 

electronic and written/paper comments 

received, go to https://

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 Dockets Management 

Staff, 5630 Fishers Lane, Rm. 1061, 

Rockville, MD 20852, 240–402–7500. 

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: Under the 

PRA (44 U.S.C. 3501–3521), 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. 

Human Drug Compounding Under 

Sections 503A and 503B of the Federal 

Food, Drug, and Cosmetic Act 

OMB Control Number 0910–0800— 

Revision 

This information collection helps 

support implementation of sections 

503A (21 U.S.C. 353a) and 503B (21 

U.S.C. 353b) of the Federal Food Drug 

and Cosmetic Act (FD&C Act), which 

govern requirements for pharmacy 

compounding and outsourcing facilities, 

respectively. For efficiency of Agency 

operations, we are revising the 

information collection to include related 

reporting activities currently approved 

under OMB control number 0910–0827. 

Specifically, upon electing and in order 

to become an outsourcing facility, 

respondents must register under section 

503B of the FD&C Act and submit 

certain reports and updates to FDA. The 

information is required to be submitted 

by electronic means unless otherwise 

exempt, and prepared in such form and 

manner as the Secretary of the 

Department of Health and Human 

Services may prescribe through 

regulation or guidance. In the guidance 

for industry ‘‘Electronic Drug Product 

Reporting for Human Drug 

Compounding Outsourcing Facilities 

Under Section 503B of the Federal 

Food, Drug, and Cosmetic Act,’’ 

(December 2016) available on our 

website at https://www.fda.gov/media/ 

90173/download, we explain how 

facilities that elect to register with FDA 

as outsourcing facilities are to submit 

drug product reports, consistent with 

section 503B of the FD&C Act. The 

guidance document describes who must 

report and what information must be 

provided to FDA. The guidance 

document also explains that drug 

compounding reports must be submitted 

in structured product labeling (SPL) 

format using FDA’s electronic 

submissions system, and discusses the 

consequences of outsourcing facilities’ 

failure to submit reports. 

We estimate the burden of this 

collection of information as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Section 503B of the FD&C act Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Initial product reports ................................................... 3 53 159 0.0833 (5 minutes) 13.25 

Waiver request from electronic submission of initial 

product reports.

1 1 1 1 ............................. 1 

June product reports ................................................... 75 53 3,975 0.025 (1.5 minutes) 99.375 

December product reports ........................................... 75 53 3,975 0.025 (1.5 minutes) 99.375 


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Federal Register / Vol. 87, No. 117 / Friday, June 17, 2022 / Notices 36509 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued 

Section 503B of the FD&C act Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

Waiver request from electronic submission of product 

reports.

1 1 1 1 ............................. 1 

Total ...................................................................... ........................ ........................ ........................ ................................ 214 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Respondents to this collection of 

information are outsourcing facilities. 

Based upon our evaluation of the 

information collection, we have 

adjusted our estimate downward by 16 

hours (from 230 to 214) annually to 

reflect more recent data. We estimate 

that each year three outsourcing 

facilities will submit a product report 

upon initial registration under section 

503B of the FD&C Act. We estimate that 

twice each year 75 outsourcing facilities 

will submit a report identifying all 

human drugs compounded in the 

facility in the previous 6 months. For 

the purposes of this estimate, each 

product’s SPL submission is considered 

a separate product response, and 

therefore each facility’s product report 

will include multiple product 

responses. We estimate that each facility 

will average 53 product responses. We 

expect each product report will consist 

of multiple product responses per 

facility and estimate that preparing and 

submitting this information 

electronically may take up to 5 minutes 

for each initial product response. 

Assuming an average of 53 product 

responses per facility, we estimate that, 

for semiannual reports, preparing and 

submitting this information 

electronically will take 1.5 minutes per 

product response. Our burden estimate 

for semiannual product report 

submissions is lower than for initial 

product reports because outsourcing 

facilities can save each product 

response once initially created and 

submitted. For subsequent reports, an 

outsourcing facility may resubmit the 

same file(s) after changing the RootID 

and version number (both SPL 

metadata), effective date (to identify the 

reporting period), and the number of 

units produced, along with other data as 

appropriate, to appropriate values for 

the reporting period. Furthermore, if a 

product was not compounded during a 

particular reporting period, no product 

response would be sent for that product 

during that reporting period. 

We expect to receive no more than 

one waiver request from the electronic 

submission process for initial product 

reports and semiannual reports, and that 

each waiver request will take 60 

minutes to prepare and submit. 

Dated: June 13, 2022. 

Lauren K. Roth, 

Associate Commissioner for Policy. 

[FR Doc. 2022–13068 Filed 6–16–22; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–N–3662] 

Agency Information Collection 

Activities; Submission for Office of 

Management and Budget Review; 

Comment Request; Guidance on 

Reagents for Detection of Specific 

Novel Influenza A Viruses 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or we) 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: Submit written comments 

(including recommendations) on the 

collection of information by July 18, 

2022. 

ADDRESSES: To ensure that comments on 

the information collection are received, 

OMB recommends that written 

comments be submitted to https://

www.reginfo.gov/public/do/PRAMain. 

Find this particular information 

collection by selecting ‘‘Currently under 

Review—Open for Public Comments’’ or 

by using the search function. The OMB 

control number for this information 

collection is 0910–0584. Also include 

the FDA docket number found in 

brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Rachel Showalter, Office of Operations, 

Food and Drug Administration, Three 

White Flint North, 10A–12M, 11601 

Landsdown St., North Bethesda, MD 

20852, 240–994–7399, 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. 

Guidance on Reagents for Detection of 

Specific Novel Influenza A Viruses—21 

CFR Part 866 

OMB Control Number 0910–0584— 

Extension 

In accordance with section 513 of the 

Federal Food, Drug, and Cosmetic Act 

(FD&C Act) (21 U.S.C. 360c), FDA 

evaluated an application for an in vitro 

diagnostic device for detection of 

influenza subtype H5 (Asian lineage), 

commonly known as avian flu. FDA 

concluded that this device is properly 

classified into class II in accordance 

with section 513(a)(1)(B) of the FD&C 

Act, because it is a device for which the 

general controls by themselves are 

insufficient to provide reasonable 

assurance of the safety and effectiveness 

of the device, but there is sufficient 

information to establish special controls 

to provide such assurance. The statute 

permits FDA to establish as special 

controls many different things, 

including postmarket surveillance, 

development and dissemination of 

guidance recommendations, and ‘‘other 

appropriate actions as the Secretary [of 

HHS] deems necessary’’ (section 

513(a)(1)(B) of the FD&C Act). This 

information collection is a measure that 

FDA determined to be necessary to 

provide reasonable assurance of safety 

and effectiveness of reagents for 

detection of specific novel influenza A 

viruses. 

FDA issued an order classifying the 

H5 (Asian lineage) diagnostic device 

into class II on March 22, 2006 (71 FR 

14377), establishing the special controls 

necessary to provide reasonable 

assurance of the safety and effectiveness 

of that device and similar future 

devices. The new classification was 

codified in 21 CFR 866.3332, a 

regulation that describes the new 


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