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:// 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
50886 Federal Register / Vol. 82, No. 211 / Thursday, November 2, 2017 / Notices 

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– 

2010–N–0988 for ‘‘Agency Information 

Collection Activities; Proposed 

Collection; Comment Request; 

Regulations for In Vivo 

Radiopharmaceuticals Used for 

Diagnosis and Monitoring.’’ 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: 

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. 3501–3520), 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. 

Regulations for In Vivo 

Radiopharmaceuticals Used for 

Diagnosis and Monitoring 

OMB Control Number 0910–0409— 

Extension 

This information collection supports 

FDA regulations found in 21 CFR part 

315. These regulations require 

manufacturers of diagnostic 

radiopharmaceuticals to submit 

information that demonstrates the safety 

and effectiveness of a new diagnostic 

radiopharmaceutical or of a new 

indication for use of an approved 

diagnostic radiopharmaceutical. The 

regulations also describe the kinds of 

indications for diagnostic 

radiopharmaceuticals and some of the 

criteria that the Agency uses to evaluate 

the safety and effectiveness of a 

diagnostic radiopharmaceutical under 

section 505 of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 355) (the 

FD&C Act) and section 351 of the Public 

Health Service Act (42 U.S.C. 262) (the 

PHS Act). Information about the safety 

or effectiveness of a diagnostic 

radiopharmaceutical enables FDA to 

properly evaluate the safety and 

effectiveness profiles of a new 

diagnostic radiopharmaceutical or a 

new indication for use of an approved 

diagnostic radiopharmaceutical. 

The regulations clarify existing FDA 

requirements for approval and 

evaluation of drug and biological 

products already in place under the 

authorities of the FD&C Act and the PHS 

Act. The information, which is usually 

submitted as part of a new drug 

application or biologics license 

application or as a supplement to an 

approved application, typically 

includes, but is not limited to, 

nonclinical and clinical data on the 

pharmacology, toxicology, adverse 

events, radiation safety assessments, 

and chemistry, manufacturing, and 

controls. The content and format of an 

application for approval of a new drug 


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Federal Register / Vol. 82, No. 211 / Thursday, November 2, 2017 / Notices 50887 

are set forth in 21 CFR 314.50, and 

approved under OMB control number 

0910–0001. This information collection 

supports part 315, currently approved 

under OMB control number 0910–0409. 

Based on past submissions (human 

drug applications and/or new indication 

supplements for diagnostic 

radiopharmaceuticals), we estimate two 

submissions will be received annually. 

We estimate the time needed to prepare 

a complete application for a diagnostic 

radiopharmaceutical to be 

approximately 10,000 hours, roughly 

one-fifth of which, or 2,000 hours, is 

estimated to be spent preparing the 

portions of the application that would 

be affected by these regulations. The 

regulations do not impose any 

additional reporting burden for safety 

and effectiveness information on 

diagnostic radiopharmaceuticals beyond 

the estimated burden of 2,000 hours 

because safety and effectiveness 

information is already required by 

§ 314.50 (collection of information 

approved under OMB control number 

0910–0001). In fact, clarification in 

these regulations of FDA’s criteria for 

evaluation of diagnostic 

radiopharmaceuticals is intended to 

streamline overall information 

collection burdens, particularly for 

diagnostic radiopharmaceuticals that 

may have well-established, low-risk 

safety profiles, by enabling 

manufacturers to tailor information 

submissions and avoid unnecessary 

clinical studies. 

FDA estimates the burden of this 

information collection as follows: 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section Number of 

respondents 

Number of 

responses 

per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

(in hours) 

Total hours 

Diagnostic Radiopharmaceuticals—315.4, 315.5, and 315.6 ................. 2 1 2 2,000 4,000 

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

Table 1 contains estimates of the 

annual reporting burden for the 

preparation of the safety and 

effectiveness sections of an application 

that are imposed by the applicable 

regulations. This estimate does not 

include time needed to conduct studies 

and clinical trials or other research from 

which the reported information is 

obtained. 

Dated: October 27, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23836 Filed 11–1–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

National Institute of Nursing Research; 

Notice of Closed Meeting 

Pursuant to section 10(d) of the 

Federal Advisory Committee Act, as 

amended, notice is hereby given of the 

following meeting. 

The meeting will be closed to the 

public in accordance with the 

provisions set forth in sections 

552b(c)(4) and 552b(c)(6), Title 5 U.S.C., 

as amended. The grant applications and 

the discussions could disclose 

confidential trade secrets or commercial 

property such as patentable material, 

and personal information concerning 

individuals associated with the grant 

applications, the disclosure of which 

would constitute a clearly unwarranted 

invasion of personal privacy. 

Name of Committee: National Institute of 

Nursing Research Special Emphasis Panel; 

NINR Clinical Trial Planning Grant. 

Date: November 17, 2017. 

Time: 1:00 p.m. to 3:00 p.m. 

Agenda: To review and evaluate grant 

applications. 

Place: National Institutes of Health, 

National Institute of Nursing Research, One 

Democracy Plaza, 6701 Democracy 

Boulevard, Room 703, Bethesda, MD 20892 

(Telephone Conference Call). 

Contact Person: Weiqun Li, MD, Scientific 

Review Officer, National Institute of Nursing 

Research, National Institutes of Health, 6701 

Democracy Boulevard, Room 710, Bethesda, 

MD 20892, (301) 594–5966, 

wli@mail.nih.gov. 

(Catalogue of Federal Domestic Assistance 

Program Nos. 93.361, Nursing Research, 

National Institutes of Health, HHS) 

Dated: October 30, 2017. 

Sylvia L. Neal, 

Program Analyst, Office of Federal Advisory 

Committee Policy. 

[FR Doc. 2017–23865 Filed 11–1–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Government-Owned Inventions; 

Availability for Licensing 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The inventions listed below 

are owned by an agency of the U.S. 

Government and are available for 

licensing in the U.S. 

FOR FURTHER INFORMATION CONTACT: 

Licensing information and copies of the 

patent applications listed below may be 

obtained by emailing the indicated 

licensing contact Michael Shmilovich, 

shmilovm@nih.gov at the National 

Heart, Lung, and Blood, Office of 

Technology Transfer and Development 

Office of Technology Transfer, 31 Center 

Drive Room 4A29, MSC2479, Bethesda, 

MD 20892–2479; telephone: 301–402– 

5579. A signed Confidential Disclosure 

Agreement may be required to receive 

copies of the patent applications. 

SUPPLEMENTARY INFORMATION: This 

notice is in accordance with 35 U.S.C. 

209 and 37 CFR 404 to achieve 

commercialization of results of 

federally-funded research and 

development. Foreign patent 

applications are filed on selected 

inventions to extend market coverage 

for companies and may also be available 

for licensing. A description of the 

technology follows. 

Endo-Cameral Closure Device 

Description of Technology: Devices 

and methods for closing a hole in the 

wall of a cardiovascular structure from 

the inside using a self-assembling 

closure device. The closure device can 

be delivered to the subject hole from the 

inside of the cardiovascular chamber 

using a transcatheter approach. The 

methods are techniques involve 

deploying the closure device from the 

delivery device such that an endocameral portion of the closure device 

self-expands first to cover the hole from 

the inside, and then extra-cameral arms 

of the device are released to self-deploy 

against the outside of the wall by 


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