50884 Federal Register / Vol. 82, No. 211 / Thursday, November 2, 2017 / Notices 

Dated: October 30, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23903 Filed 11–1–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–6129] 

Assessment of Food and Drug 

Administration Hiring and Retention; 

Public Meeting; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA, the Agency, or 

we) is announcing the following public 

meeting entitled ‘‘Assessment of FDA 

Hiring and Retention’’. The purpose of 

the public meeting is to share high-level 

findings from a recently completed 

diagnostic assessment of FDA’s hiring 

process conducted by a qualified, 

independent contractor with expertise 

in assessing human resources operations 

and transformation. The purpose also is 

to outline a set of near-term actions FDA 

will or can take to improve the hiring 

process, provide an update on FDA’s 

progress toward Prescription Drug User 

Fee Act (PDUFA) and Biosimilar User 

Fee Act (BsUFA) user fee hiring and 

retention commitments, and solicit 

input on actions FDA is taking and any 

further recommendations or priorities 

FDA should pursue with regard to the 

hiring process. 

DATES: The public meeting will be held 

on November 30, 2017, from 9 a.m. to 

12 noon. Submit either electronic or 

written comments on this public 

workshop by January 15, 2018. See the 

SUPPLEMENTARY INFORMATION section for 

registration date and information. 

ADDRESSES: The public meeting will be 

held at the FDA’s White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Section A, Silver Spring, MD 

20993. Entrance for the public meeting 

participants (non-FDA employees) is 

through Building 1 where routine 

security check procedures will be 

performed. For parking and security 

information, please refer to https://

www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. 

A summary report of evaluation 

findings related to the hiring process, 

conducted by an independent third 

party contractor, will be published in 

the docket by November 15, 2017, and 

will be titled ‘‘Initial Assessment of 

FDA Hiring and Retention.’’ 

You may submit comments as 

follows. Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before January 15, 2018. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of January 15, 2018. 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.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–N–6129 for ‘‘Assessment of FDA 

Hiring and Retention; Public Meeting; 

Request for Comments.’’ 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. 

• 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.gpo.gov/ 

fdsys/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. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Brounstein, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 1, Rm. 1312, Silver Spring, 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
Federal Register / Vol. 82, No. 211 / Thursday, November 2, 2017 / Notices 50885 

1PDUFA Reauthorization Performance Goals and 

Procedures Fiscal Years 2018 Through 2022, 

https://www.fda.gov/downloads/forindustry/ 

userfees/prescriptiondruguserfee/ucm511438.pdf. 

2Biosimilar Biological Product Reauthorization 

Performance Goals and Procedures Fiscal Years 

2018 Through 2022, https://www.fda.gov/ 

downloads/ForIndustry/UserFees/ 

BiosimilarUserFeeActBsUFA/UCM521121.pdf. 

MD 20993, 301–796–0674, 

OMPTfeedback@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is responsible for protecting and 

promoting the public health by helping 

to ensure the safety, efficacy, and 

security of human and veterinary drugs, 

biological products, and medical 

devices; and by helping to ensure the 

safety of the nation’s food supply, 

cosmetics, and products that emit 

radiation. FDA also has responsibility 

for regulating the manufacturing, 

marketing, and distribution of tobacco 

products to protect the public health 

and to reduce tobacco use by minors. 

Included in this is a mandate to 

advance the public health mission by 

helping to speed innovations that make 

medical products more effective, safer, 

and more affordable, and helping the 

public access accurate science-based 

information for FDA-regulated products. 

Just as the science and technology 

underlying new medical products is 

advancing, the science of development 

and evaluation of medical products and 

clinical care is also dramatically 

improving. To enable FDA to continue 

to effectively evaluate these innovative 

developments, a specialized workforce 

is required to support the Agency’s 

regulatory science and operations 

initiatives. 

Over the past 5 years, the Agency has 

struggled with challenges related to its 

hiring processes, including challenges 

in managing the hiring process and 

bringing the right skills to the Agency. 

FDA has demonstrated that diagnosing 

the current state and drastically 

reimagining the hiring process is a top 

priority and is committed to 

implementing new, bold, consistent, 

and high quality hiring processes to 

tackle these challenges. The criticality 

of these priorities is consistent with the 

PDUFA VI and BsUFA II user-fee 

commitments. These commitments 

include the use of a qualified, 

independent contractor with expertise 

in assessing human resources operations 

and transformation to perform an initial 

baseline assessment no later than 

December 31, 2017, and a public 

meeting no later than December 31, 

2017, to present and discuss report 

findings.1 2

II. Topics for Discussion at the 

Assessment of FDA Hiring and 

Retention Public Meeting 

The agenda will be posted prior to the 

meeting at: https://www.fda.gov/ 

NewsEvents/ 

MeetingsConferencesWorkshops/ 

ucm577055.htm, and will involve a 

plenary presentation related to the 

assessment findings summarized in the 

‘‘Initial Assessment of FDA’s Hiring and 

Retention’’ report and an open public 

comment period. 

Registration: The FDA Conference 

Center at the White Oak location is a 

Federal facility with security procedures 

and limited seating. Attendance will be 

free and on a first-come, first-served 

basis. If you wish to attend (either in 

person or by webcast) (see Streaming 

Webcast of the Public Meeting), please 

register online by 12 noon on Friday, 

November 24, Eastern Time at the 

following Web site: https://

www.fda.gov/NewsEvents/ 

MeetingsConferencesWorkshops/ 

ucm577055.htm. Please provide 

complete contact information for each 

attendee, including name, title, 

affiliation, address, email, and 

telephone. You will receive 

confirmation of your registration. 

If you need special accommodations 

due to a disability, please contact 

OMPTfeedback@fda.hhs.gov no later 

than Friday, November 24, at 12 noon 

Eastern Time. 

Streaming Webcast of the Public 

Meeting: This public meeting will also 

be live webcast. To join the meeting via 

the webcast, please go to https://

collaboration.fda.gov/ 

fdahiringretention. If you have never 

attended a Connect Pro event before, 

test your connection at https://

collaboration.fda.gov/common/help/en/ 

support/meeting_test.htm. To get a 

quick overview of the Connect Pro 

program, visit https://www.adobe.com/ 

go/connectpro_overview. FDA has 

verified the Web site addresses in this 

document, as of the date this document 

publishes in the Federal Register, but 

Web sites are subject to change over 

time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). A link to the 

transcript will also be available on the 

internet at https://www.fda.gov/ 

NewsEvents/ 

MeetingsConferencesWorkshops/ 

ucm577055.htm. 

Dated: October 30, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23899 Filed 11–1–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0998] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Regulations for In 

Vivo Radiopharmaceuticals Used for 

Diagnosis and Monitoring 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 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 information 

collection in the regulations for in vivo 

radiopharmaceuticals used for diagnosis 

and monitoring. 

DATES: Submit either electronic or 

written comments on the collection of 

information by January 2, 2018. 

ADDRESSES: You may submit comments 

as follows. Please note that late, 

untimely filed comments will not be 

considered. Electronic comments must 

be submitted on or before January 2, 

2018. The https://www.regulations.gov 

electronic filing system will accept 

comments until midnight Eastern Time 

at the end of January 2, 2018. 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:// 


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