Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 49371 

Estimated annual burden hours: FR 

28: 3,500 hours, FR 28s: 33 hours, FR 

28i: 75 hours, Total: 3,608 hours. 

General description of report: The 

Application for Employment with the 

Board of Governors of the Federal 

Reserve System (Application) collects 

information to determine the 

qualifications and availability of 

applicants for employment with the 

Board of Governors of the Federal 

Reserve System (Board). The FR 28 

collects information on education and 

training, employment record, military 

service record, and other information 

since the time the applicant left high 

school. Included with the FR 28 are two 

supplemental questionnaires: (1) The 

Applicant’s Voluntary SelfIdentification Form (FR 28s), which 

collects information on the applicant’s 

gender and ethnic group and (2) The 

Research Assistant Candidate Survey of 

Interests (FR 28i), which collects 

information from candidates applying 

for Research Assistant (RA) positions on 

their level of interest in economics and 

related areas. The Board receives 

approximately 3,500 applications per 

year, both solicited and unsolicited, 

from members of the public who would 

like to be considered for employment at 

the Board. Since the applicant is usually 

either hired by the Board or finds other 

employment within the two years that 

the Board retains the Application, the 

applicant generally files the Application 

once. 

The Application is comprised of eight 

sections: Background, Education and 

Training, Employment Record, Military 

Service Record, References, General, 

Remarks, and Notes. The first six 

sections collect information on specific 

aspects of the applicant’s qualifications. 

The Background section collects name, 

address, telephone, and citizenship 

information and the position for which 

the applicant is applying. The 

Education and Training section collects 

detailed information on the applicant’s 

educational history and skills set. The 

Employment Record section collects a 

chronological summary of work 

experience. The Military Service Record 

section collects information on service 

branch, rank, duties, and discharge. The 

References section collects information 

on three references. The General section 

collects information on criminal 

records, discharge from employment, 

willingness to travel, and relations to or 

acquaintances with Board staff or 

officers and directors of financial 

institutions. The Remarks section 

provides the applicant an opportunity to 

provide further information regarding 

his or her qualifications. The Notes 

section explains what is required of the 

applicant prior to an interview and what 

may be required of the applicant if he 

or she is offered a position (for example, 

transcripts, medical examination, or 

drug test). 

The FR 28s is comprised of four 

sections: (1) Name and gender, in which 

the applicant is asked to check the box 

that corresponds to gender or check ‘‘I 

do not wish to disclose’’, (2) position for 

which the applicant is applying, (3) 

ethnicity self-identification, in which 

the applicant is asked to choose 

between Hispanic or Latino or Not 

Hispanic or Latino, or ‘‘I do not wish to 

disclose,’’ and (4) race selfidentification, in which the applicant is 

asked to choose one or more among 

American Indian or Alaskan Native, 

Asian, Black or African-American, 

Native Hawaiian or Other Pacific 

Islander, White, or ‘‘I do not wish to 

disclose.’’ The Board uses this 

information to comply with federal 

equal employment opportunity (EEO) 

recordkeeping and reporting 

requirements, other legal requirements, 

and as an input to its self-analysis of 

hiring practices. Information collected 

on the FR 28s has no bearing on the 

determination of an applicant’s jobrelated qualifications and completion of 

the self-identification form is voluntary. 

The FR 28i is comprised of three 

sections in which research assistant 

candidates are asked to rate their level 

of interest in categories of economics 

and related research areas, experience 

with various software packages and 

statistical programming languages, and 

interest in pursuing educational 

opportunities after leaving the Board. 

The FR 28i helps to streamline the 

recruitment process. 

Legal authorization and 

confidentiality: The Board’s Legal 

Division has determined that the 

Application (including the two 

supplemental questionnaires) is 

required to obtain the benefit of Board 

employment. It is authorized pursuant 

to sections 10(4) and 11(1) of the 

Federal Reserve Act, which provide the 

Federal Reserve Board broad authority 

over employment of staff (12 U.S.C. 244 

and 248(l)). Information provided on the 

Application (including the two 

supplemental questionnaires) will be 

kept confidential under exemption 

(b)(6) of the Freedom of Information Act 

(FOIA) to the extent that the disclosure 

of information ‘‘would constitute a 

clearly unwarranted invasion of 

personal privacy.’’ (5 U.S.C. 552(b)(6)). 

For example, the release of information 

such as an applicant’s date of birth, 

address, phone number, and personal 

information regarding any references 

provided would likely constitute a 

clearly unwarranted invasion of 

personal privacy, and would be kept 

confidential. However, the release of 

information such as the educational and 

professional qualifications of applicants 

would not likely constitute a clearly 

unwarranted invasion of personal 

privacy and would not be kept 

confidential. 

Current actions: On July 28, 2017, the 

Federal Reserve published a notice in 

the Federal Register (82 FR 35202) 

requesting public comment for 60 days 

on the extension, with revision, of the 

Application for Employment with the 

Board of Governors of the Federal 

Reserve System. The Board proposed 

minor revisions to the FR 28 form, 

including (1) adding fields in the 

employment history section for job type, 

shift, employee status, and desired 

compensation, (2) adding fields in the 

education and training section for issue 

and expiration date for certifications 

and professional licenses, (3) adding 

fields in the references section for 

relationship, type, and length of 

relationship with the reference, and (4) 

adding fields in the submission section 

to allow for withdrawal of the 

application and a request for the 

applicant to provide a reason for 

withdrawal. In addition, the Board 

proposed to revise the FR 28i by adding 

a section to allow an open-ended 

response by applicants to describe how 

they have demonstrated attributes that 

are displayed by successful research 

assistants in the Economics Divisions. 

The comment period for this notice 

expired on September 26, 2017. The 

Board did not receive any comments. 

The revisions will be implemented as 

proposed. 

Board of Governors of the Federal Reserve 

System, October 20, 2017. 

Ann E. Misback, 

Secretary of the Board. 

[FR Doc. 2017–23150 Filed 10–24–17; 8:45 am] 

BILLING CODE 6210–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5961] 

In Vitro Metabolism- and TransporterMediated Drug-Drug Interaction 

Studies, and Clinical Drug Interaction 

Studies—Study Design, Data Analysis, 

and Clinical Implications; Draft 

Guidances for Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 


sradovich on DSK3GMQ082PROD with NOTICES
49372 Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of two draft 

guidances for industry entitled ‘‘In Vitro 

Metabolism- and Transporter-Mediated 

Drug-Drug Interaction Studies’’ (in vitro 

DDI guidance) and ‘‘Clinical Drug 

Interaction Studies—Study Design, Data 

Analysis, and Clinical Implications’’ 

(clinical DDI guidance). These two draft 

guidances will update and replace the 

revised draft guidance for industry 

entitled ‘‘Drug Interaction Studies— 

Study Design, Data Analysis, 

Implications for Dosing, and Labeling 

Recommendations’’ issued February 21, 

2012 (2012 draft guidance). These draft 

guidances are intended to assist drug 

developers in the planning and 

evaluation of drug-drug interaction 

(DDI) potential during drug 

development. In particular, the in vitro 

DDI guidance focuses on in vitro 

experimental approaches for evaluating 

metabolizing enzyme- and transporterbased drug interaction potential and 

how to extrapolate in vitro data to 

decide on the need for clinical DDI 

studies. The clinical DDI guidance 

focuses on clinical studies that evaluate 

the potential for DDIs, which alter a 

drug’s pharmacokinetics by modulating 

the effects of drug metabolizing 

enzymes and transporters, and advises 

sponsors on the timing and design of the 

clinical studies, interpretation of the 

results, and options for managing DDIs 

in patients. Together, these two draft 

guidances describe a systematic, riskbased approach to the assessment of 

DDIs. 

DATES: Submit either electronic or 

written comments on these draft 

guidances by January 23, 2018 to ensure 

that the Agency considers your 

comment on these two draft guidances 

before it begins work on the final 

versions of these guidances. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

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–D–5961 for ‘‘In Vitro Metabolismand Transporter-Mediated Drug-Drug 

Interaction Studies, and Clinical Drug 

Interaction Studies—Study Design, Data 

Analysis, and Clinical Implications; 

Draft Guidances for Industry; 

Availability.’’ Received comments 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. 

You may submit comments on any 

guidance at any time (see 21 CFR 

10.115(g)(5)). 

Submit written requests for single 

copies of the draft guidances to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, Silver Spring, MD 20993– 

0002. Send one self-addressed adhesive 

label to assist that office in processing 

your requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance documents. 

FOR FURTHER INFORMATION CONTACT: 

Lauren Brum, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 3188, 

Silver Spring, MD 20903–0002, 301– 

796–5008, or OCP@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

two draft guidances for industry entitled 

‘‘In Vitro Metabolism- and TransporterMediated Drug-Drug Interaction 

Studies’’ and ‘‘Clinical Drug Interaction 

Studies—Study Design, Data Analysis, 

and Clinical Implications.’’ The 

concomitant use of more than one 

medication in a patient is common. 

Unanticipated, unrecognized, or 

mismanaged DDIs are an important 

cause of morbidity and mortality 

associated with prescription drug use 

and has occasionally been the basis for 

withdrawal of approved drugs from the 

market. In some instances, 

understanding how to safely manage a 

DDI can allow approval of a drug that 

would otherwise have an unacceptable 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 205 / Wednesday, October 25, 2017 / Notices 49373 

level of risk. Clinically relevant DDIs 

between an investigational drug and 

other drugs should therefore: (1) Be 

defined during drug development as 

part of an adequate assessment of the 

drug’s overall benefit/risk profile; (2) be 

known at the time of the drug’s 

approval; and (3) be communicated in 

labeling. These two draft guidances are 

intended to assist drug developers in the 

planning and evaluation of DDI 

potential during drug development. In 

particular, the in vitro DDI guidance 

focuses on in vitro experimental 

approaches for evaluating metabolizing 

enzyme- and transporter-based drug 

interaction potential, and how to 

extrapolate in vitro data to decide on the 

need for clinical DDI studies. The 

appendix of the in vitro DDI guidance 

includes considerations in the choice of 

in vitro experimental systems, key 

issues regarding in vitro experimental 

conditions, and a more detailed 

explanation of model-based DDI 

prediction strategies. If in vitro 

assessments indicate the need to 

conduct clinical DDI studies, sponsors 

should consult the related clinical DDI 

guidance. The clinical DDI guidance 

focuses on clinical studies that evaluate 

DDIs that alter a drug’s 

pharmacokinetics by modulating the 

effects of drug metabolizing enzymes 

and/or transporters and advises 

sponsors on the timing and design of the 

clinical studies, interpretation of the 

results, and options for DDI 

management in patients. Together, the 

two draft guidances describe a 

systematic, risk-based approach to 

evaluation and communication of DDIs. 

In the Federal Register of February 

21, 2012 (77 FR 9946), FDA announced 

the availability of a revised draft 

guidance entitled ‘‘Drug Interaction 

Studies—Study Design, Data Analysis, 

Implications for Dosing, and Labeling 

Recommendations.’’ We received 

comments on the 2012 draft guidance 

and have considered these comments 

while updating the information in the 

two draft guidances. In addition, new 

developments in the field have been 

incorporated to reflect the Agency’s 

current thinking. 

The Agency decided to divide the 

2012 draft guidance into two guidances 

with one focusing on in vitro DDI 

evaluation and the other focusing on 

clinical DDI evaluation. We are 

publishing the two draft guidances to 

collect additional public comments. 

These new draft guidances focus on 

metabolism- and transporter-based drug 

interactions. Other types of interactions, 

e.g., drug-therapeutic protein 

interactions and pH-dependent drug 

interactions, are not included. Separate 

guidances will be developed to cover 

other types of DDIs. In addition, a draft 

guidance specific to Section 7 (Drug 

Interactions) labeling will be developed 

to delineate the communication of DDI 

information in labeling. 

These two draft guidances are being 

issued consistent with FDA’s good 

guidance practices regulation (21 CFR 

10.115). These draft guidances, when 

finalized, will represent the Agency’s 

current thinking on ‘‘In Vitro 

Metabolism- and Transporter-Mediated 

Drug-Drug Interaction Studies’’ and 

‘‘Clinical Drug Interaction Studies— 

Study Design, Data Analysis, and 

Clinical Implications.’’ It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. 

These guidances are not subject to 

Executive Order 12866. 

II. Paperwork Reduction Act of 1995 

These draft guidances refer to 

previously approved collections of 

information found in FDA regulations. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR 314.50(d) have 

been approved under OMB control 

number 0910–0001. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at either 

https://www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm or https://

www.regulations.gov. 

Dated: October 19, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–23102 Filed 10–24–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–5966] 

Breakthrough Devices Program; Draft 

Guidance for Industry and Food and 

Drug Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of availability. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the draft 

guidance entitled ‘‘Breakthrough 

Devices Program; Draft Guidance for 

Industry and Food and Drug 

Administration Staff.’’ This guidance 

document describes policies that FDA 

intends to use to implement the new 

Breakthrough Devices Program, 

established by the 21st Century Cures 

Act (Cures Act). The Breakthrough 

Devices Program supersedes and 

combines elements from FDA’s 

Expedited Access Pathway (EAP), 

which was intended to facilitate the 

development and expedite review of 

breakthrough technologies, as well as 

the Priority Review Program, which 

implemented statutory criteria for 

granting priority review to premarket 

approval applications (PMAs) and 

applied those criteria to other types of 

premarket submissions for medical 

devices. This draft guidance clarifies 

certain principles and features of the 

new program, the designation criteria 

for Breakthrough Devices, the 

designation request review process, the 

process for withdrawing from the 

program, as well as the recommended 

information device manufacturers 

should provide in their designation 

request for entrance into the program. 

This draft guidance is not final nor is it 

in effect at this time. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by December 26, 2017 to ensure that the 

Agency considers your comment on this 

draft guidance before it begins work on 

the final version of the guidance. 

ADDRESSES: You may submit comments 

on any guidance at any time as follows: 

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. 


sradovich on DSK3GMQ082PROD with NOTICES