41132 Federal Register / Vol. 87, No. 131 / Monday, July 11, 2022 / Notices 

available variant data, see: http://

www.nhgeneticvariant.com/. 

A minority of resulting data from 

DNA specimens are not restricted. In 

these cases, the resulting data will 

undergo disclosure review by the NCHS 

Confidentiality Officer and NCHS 

Disclosure Review Board or designee 

before the linked data are sent to the 

investigators for quality control review. 

Once approved by disclosure review 

and after the investigators have signed 

the Data Sharing Agreement, the linked 

data file will be sent to the investigators 

for use pursuant to the terms of the 

relevant agreement. The quality control 

review must take place within 60 days 

or a negotiated length of time, and the 

return of the data to NCHS within the 

next 30 days so these data may be 

released to the public. 

Disposition of Specimens 

The provided DNA specimens cannot 

be used for any purpose other than the 

specifically requested purpose outlined 

in the proposal and approved through 

the Scientific and Institutional Review. 

No DNA specimens can be shared with 

others, including other investigators, 

unless specified in the proposal and so 

approved. Specimens must be returned 

upon completion of the approved 

project or destroyed. Both options 

require written approval from the 

NHANES Project Officer. 

Cost Schedule for Providing NHANES 

DNA Specimens 

There is a nominal processing fee of 

$17.17 for each DNA specimen received 

from an NHANES DNA Repository. The 

costs include collecting, processing, 

storing, and retrieving the DNA 

specimens, reviewing proposals, and 

preparing the data files. The costs listed 

are for the recurring laboratory materials 

to dispense and prepare the DNA 

specimens during collection and 

shipping. The NHANES DNA Specimen 

repository costs include long-term 

storage (including inventory 

management and materials and 

equipment) and accessioning of 

specimens and specimen retrieval for 

shipment to the investigator. Labor costs 

are based on a proposal administrator to 

manage the proposal process and 

computer programmers at NCHS who 

prepare the data files for the release of 

the data along with documentation on 

the NHANES web page. If the 

investigators request to use the DNA 

specimens for another proposed project 

after the completion of the initial 

project, the additional cost will be 5 

percent of the specimen set cost to 

handle the processing of the data and 

management of the subsequent proposal 

process. A new proposal must be 

submitted and go through the approval 

process before any additional use of the 

DNA specimens. 

COST SCHEDULE FOR NHANES DNA SPECIMENS

Total costs 

1999–2002, 

2007–2008, 

2009–2010, 

2011–2012 

complete sets 

1999–2002, 

2007–2008, 

2009–2010, 

2011–2012 

partial set 

NHANES III 

complete set 

Materials and equipment—contractor: plates, reagents, assays, aliquoting and packaging 

specimens; use of equipment ........................................................................................... $1.72 $5.15 $0.85 

Labor—contractor: processing, handling, and shipping; NCHS: data quality control .......... 5.66 28.31 2.83 

Proposal review and administrative expenses—contractor: inventory management and 

reporting; NCHS: management of proposal process non-NCHS: technical panel fees ... 3.43 6.87 1.72 

Space—contractor: freezer use and maintenance ............................................................... 6.36 6.36 3.17 

Cost per specimen ............................................................................................................... 17.17 46.69 8.58 

Cost per new proposal: 

1999–2002 ............................................................................................................................ 134,430.92 * 

2007–2008 ............................................................................................................................ 79,181.82 * 

2009–2010 ............................................................................................................................ 84,006.11 * 

2011–2012 ............................................................................................................................ 71,181.89 * 

III ........................................................................................................................................... ........................ ........................ 61,454.85 

Cost per additional proposal: ** 

1999–2002 ............................................................................................................................ 6,721.94 *** 

2007–2008 ............................................................................................................................ 4,130.72 *** 

2009–2010 ............................................................................................................................ 4,200.08 *** 

2011–2012 ............................................................................................................................ 3,559.95 *** 

III ........................................................................................................................................... ........................ ........................ 3,072.17 

* Cost calculated upon request. 

** Additional research using DNA specimens already obtained from previous solicitations. 

*** This charge will be 5 percent of the original cost. 

Note: Applicable CDC overhead and NCHS management and oversight charges will be added to these rates for proposals coming from federal agencies. 

Angela K. Oliver, 

Executive Secretary, Centers for Disease 

Control and Prevention. 

[FR Doc. 2022–14702 Filed 7–8–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Solicitation of Nominations for 

Appointment to the Board of Scientific 

Counselors, National Center for Injury 

Prevention and Control (BSC, NCIPC) 

ACTION: Notice. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC) is seeking 

nominations for membership on the 

BSC, NCIPC. The BSC, NCIPC consists 

of 18 experts in fields associated with 

surveillance; basic epidemiologic 

research; intervention research; and 

implementation, dissemination, and 

evaluation of promising and evidencebased strategies for the prevention of 

injury, violence, and drug abuse. 

Nominations are being sought for 


khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 87, No. 131 / Monday, July 11, 2022 / Notices 41133 

individuals who have expertise and 

qualifications necessary to contribute to 

the accomplishments of the Committee’s 

objectives. Nominees will be selected 

based on expertise in the fields of 

pertinent disciplines involved in injury, 

violence, and drug overdose prevention, 

including, but not limited to, 

epidemiology, statistics, trauma surgery, 

rehabilitation medicine, behavioral 

science/psychology, health economics, 

program evaluation, political science, 

law, criminology, informatics, and other 

aspects of injury management. Federal 

employees will not be considered for 

membership. Members may be invited 

to serve for up to four-year terms. 

Selection of members is based on 

candidates’ qualifications to contribute 

to the accomplishment of BSC, NCIPC 

objectives (https://www.cdc.gov/injury/ 

bsc/). 

DATES: Nominations for membership on 

the BSC, NCIPC must be received no 

later than September 1, 2022. Packages 

received after this time will not be 

considered for the current membership 

cycle. 

ADDRESSES: All nominations should be 

emailed to ncipcbsc@cdc.gov. 

FOR FURTHER INFORMATION CONTACT: 

Arlene Greenspan, DrPH, MPH, PT, 

Associate Director for Science, NCIPC, 

CDC, 4770 Buford Highway NE, 

Mailstop S–1069, Atlanta, Georgia 

30341; Telephone: (770) 488–1279; 

Email: ncipcbsc@cdc.gov. 

SUPPLEMENTARY INFORMATION: The U.S. 

Department of Health and Human 

Services policy stipulates that 

committee membership be balanced in 

terms of points of view represented and 

the Committee’s function. 

Appointments shall be made without 

discrimination on the basis of age, race, 

ethnicity, gender, sexual orientation, 

gender identity, HIV status, disability, 

and cultural, religious, or 

socioeconomic status. Nominees must 

be U.S. citizens and cannot be full-time 

employees of the U.S. Government. 

Current participation on federal 

workgroups or prior experience serving 

on a federal advisory committee does 

not disqualify a candidate; however, 

HHS policy is to avoid excessive 

individual service on advisory 

committees and multiple committee 

memberships. Committee members are 

Special Government Employees, 

requiring the filing of financial 

disclosure reports at the beginning and 

annually during their terms. CDC 

reviews potential candidates for BSC, 

NCIPC membership each year and 

provides a slate of nominees for 

consideration to the Secretary of HHS 

for final selection. HHS notifies selected 

candidates of their appointment near 

the start of the term in September, or as 

soon as the HHS selection process is 

completed. Note that the need for 

different expertise varies from year to 

year and a candidate who is not selected 

in one year may be reconsidered in a 

subsequent year. Candidates should 

submit the following items: 

D Cover letter stating area of expertise. 

D Current curriculum vitae, including 

complete contact information 

(telephone numbers, mailing address, 

email address). 

D At least one letter of 

recommendation from person(s) not 

employed by the U.S. Department of 

Health and Human Services. Candidates 

may submit letter(s) from current HHS 

employees if they wish, but at least one 

letter must be submitted by a person not 

employed by an HHS agency (i.e., CDC, 

NIH, FDA, SAMHSA, etc.). 

Nominations may be submitted by the 

candidate himself or herself or by the 

person/organization recommending the 

candidate. 

The Director, Strategic Business 

Initiatives Unit, Office of the Chief 

Operating Officer, Centers for Disease 

Control and Prevention, has been 

delegated the authority to sign Federal 

Register notices pertaining to 

announcements of meetings and other 

committee management activities for 

both the Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Kalwant Smagh, 

Director, Strategic Business Initiatives Unit, 

Office of the Chief Operating Officer, Centers 

for Disease Control and Prevention. 

[FR Doc. 2022–14714 Filed 7–8–22; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2020–E–2120 and FDA– 

2020–E–2121] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; TABRECTA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or the Agency) has 

determined the regulatory review period 

for TABRECTA and is publishing this 

notice of that determination as required 

by law. FDA has made the 

determination because of the 

submission of applications to the 

Director of the U.S. Patent and 

Trademark Office (USPTO), Department 

of Commerce, for the extension of a 

patent which claims that human drug 

product. 

DATES: Anyone with knowledge that any 

of the dates as published (see 

SUPPLEMENTARY INFORMATION) are 

incorrect may submit either electronic 

or written comments and ask for a 

redetermination by September 9, 2022. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 

during the regulatory review period by 

January 9, 2023. See ‘‘Petitions’’ in the 

SUPPLEMENTARY INFORMATION section for 

more information. 

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 September 9, 

2022. The https://www.regulations.gov 

electronic filing system will accept 

comments until 11:59 p.m. Eastern Time 

at the end of September 9, 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’’). 


khammond on DSKJM1Z7X2PROD with NOTICES