Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 40055 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifier: CMS–10545] 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

AGENCY: Centers for Medicare & 

Medicaid Services, HHS. 

ACTION: Notice. 

SUMMARY: The Centers for Medicare & 

Medicaid Services (CMS) is announcing 

an opportunity for the public to 

comment on CMS’ intention to collect 

information from the public. 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 or reinstatement of an existing 

collection of information, and to allow 

a second opportunity for public 

comment on the notice. Interested 

persons are invited to send comments 

regarding the burden estimate or any 

other aspect of this collection of 

information, including the necessity and 

utility of the proposed information 

collection for the proper performance of 

the agency’s functions, the accuracy of 

the estimated burden, ways to enhance 

the quality, utility, and clarity of the 

information to be collected and the use 

of automated collection techniques or 

other forms of information technology to 

minimize the information collection 

burden. 

DATES: Comments on the collection(s) of 

information must be received by the 

OMB desk officer by September 12, 

2018. 

ADDRESSES: When commenting on the 

proposed information collections, 

please reference the document identifier 

or OMB control number. To be assured 

consideration, comments and 

recommendations must be received by 

the OMB desk officer via one of the 

following transmissions: OMB, Office of 

Information and Regulatory Affairs, 

Attention: CMS Desk Officer, Fax 

Number: (202) 395–5806 OR, Email: 

OIRA_submission@omb.eop.gov. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

http://www.cms.hhs.gov/Paperwork

ReductionActof1995. 

2. Email your request, including your 

address, phone number, OMB number, 

and CMS document identifier, to 

Paperwork@cms.hhs.gov. 

3. Call the Reports Clearance Office at 

(410) 786–1326. 

FOR FURTHER INFORMATION CONTACT: 

Reports Clearance Office at (410) 786– 

1326. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (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. The term ‘‘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 publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

Information Collection 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Outcome and 

Assessment Information Set (OASIS) 

OASIS–C2/ICD–10; Use: This request is 

for OMB approval to modify the 

Outcome and Assessment Information 

Set (OASIS) that home health agencies 

(HHAs) are required to collect in order 

to participate in the Medicare program. 

CMS is seeking OMB approval for the 

proposed revised OASIS item set, 

referred to hereafter as OASIS–D, 

scheduled for implementation on 

January 1, 2019. The OASIS D is being 

modified to: include changes pursuant 

to the Improving Medicare Post-Acute 

Care Transformation Act of 2014 (the 

IMPACT Act); accommodate data 

element removals to reduce burden; and 

improve formatting throughout the 

document. Form Number: CMS–10545 

(OMB control number: 0938–1279); 

Frequency: Occasionally; Affected 

Public: Private Sector (Business or other 

for-profit and Not-for-profit 

institutions); Number of Respondents: 

12,149; Total Annual Responses: 

18,161,942; Total Annual Hours: 

9,943,140. (For policy questions 

regarding this collection contact Joan 

Proctor at 410–786–0949). 

Dated: August 8, 2018. 

William N. Parham, III, 

Director, Paperwork Reduction Staff Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2018–17302 Filed 8–10–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–D–2777] 

Expansion Cohorts: Use in First-InHuman Clinical Trials To Expedite 

Development of Oncology Drugs and 

Biologics; Draft Guidance for Industry; 

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 a draft 

guidance for industry entitled 

‘‘Expansion Cohorts: Use in First-InHuman Clinical Trials to Expedite 

Development of Oncology Drugs and 

Biologics.’’ The purpose of this draft 

guidance is to provide advice to 

sponsors regarding the design and 

conduct of first-in-human (FIH) clinical 

trials intended to efficiently expedite 

the clinical development of cancer 

drugs, including biological products, 

through multiple expansion cohort 

study designs. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by October 12, 2018 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 


sradovich on DSK3GMQ082PROD with NOTICES
40056 Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 

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– 

2018–D–2777 for ‘‘Expansion Cohorts: 

Use in First-In-Human Clinical Trials to 

Expedite Development of Oncology 

Drugs and Biologics.’’ 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 guidance 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, or Office of Communication, 

Outreach, and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, 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 document. 

FOR FURTHER INFORMATION CONTACT: Lee 

Pai-Scherf, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 2314, Silver Spring, 

MD 20993–0002, 301–796–3400; or 

Stephen Ripley, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Expansion Cohorts: Use in First-InHuman Clinical Trials to Expedite 

Development of Oncology Drugs and 

Biologics.’’ The purpose of this draft 

guidance is to provide advice to 

sponsors regarding the design and 

conduct of FIH clinical trials intended 

to efficiently expedite the clinical 

development of cancer drugs, including 

biological products, through multiple 

expansion cohort study designs. These 

are study designs that employ multiple, 

concurrently accruing, patient cohorts, 

where individual cohorts assess 

different aspects of the safety, 

pharmacokinetics, and anti-tumor 

activity of the drug. This guidance 

provides FDA’s current thinking 

regarding: (1) Characteristics of drug 

products best suited for consideration 

for development under a multiple 

expansion cohort study; (2) information 

to include in investigational new drug 

application submissions to justify the 

design of individual expansion cohorts; 

(3) when to interact with FDA on 

planning and conduct of multiple 

expansion cohort studies; and (4) 

safeguards to protect patients enrolled 

in FIH expansion cohort studies. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the current thinking of FDA 

on Expansion Cohorts: Use in First-InHuman Clinical Trials to Expedite 

Development of Oncology Drugs and 

Biologics. 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. This guidance is not 

subject to Executive Order 12866. 

II. Paperwork Reduction Act of 1995 

This draft guidance refers 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 the draft guidance 

have been approved under 21 CFR part 

312 at OMB control number 0910–0014; 

the guidance for industry entitled 

‘‘Formal Meetings Between the FDA and 

Sponsors or Applicants of PDUFA 

Products’’ under OMB control number 

0910–0429 is available at https://

www.fda.gov/downloads/Drugs/ 

GuidanceComplianceRegulatory

Information/Guidances/ 

UCM590547.pdf; the guidance for 

clinical trial sponsors entitled 

‘‘Establishment and Operation of 

Clinical Trial Data Monitoring’’ under 

OMB control number 0910–0581 is 

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

downloads/RegulatoryInformation/ 

Guidances/ucm127073.pdf; the 

guidance for industry entitled 

‘‘Oversight of Clinical Investigations—A 

Risk-Based Approach to Monitoring’’ 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 83, No. 156 / Monday, August 13, 2018 / Notices 40057 

under OMB control number 0910–0733 

is available at https://www.fda.gov/ucm/ 

groups/fdagov-public/@fdagov-drugsgen/documents/document/ 

ucm269919.pdf; 21 CFR parts 50 and 56 

under OMB control number 0910–0755; 

the guidance for industry entitled 

‘‘Expedited Programs for Serious 

Conditions—Drugs and Biologics’’ 

under OMB control number 0910–0765 

is available at https://www.fda.gov/ 

downloads/Drugs/GuidanceCompliance

RegulatoryInformation/Guidances/ 

UCM358301.pdf; and the ICH guidance 

for industry entitled ‘‘E6(R2) Good 

Clinical Practice: Integrated Addendum 

to ICH E6(R1)’’ under OMB control 

number 0910–0843 is available at 

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

GuidanceComplianceRegulatory

Information/Guidances/ 

UCM464506.pdf. 

III. Electronic Access 

Persons with access to the internet 

may obtain the draft guidance at https:// 

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, https://

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/default.htm, or https://

www.regulations.gov. 

Dated: August 8, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–17273 Filed 8–10–18; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–2455] 

Patient-Focused Drug Development 

Guidance: Methods To Identify What Is 

Important to Patients and Select, 

Develop, or Modify Fit-for-Purpose 

Clinical Outcome Assessments; Public 

Workshop; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public workshop; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

2-day public workshop to convene a 

discussion on methodological 

approaches that may be used to identify 

what is most important to patients and 

caregivers with respect to burden of 

disease, burden of treatment, and the 

benefits and risks in the management of 

the patient’s disease, and best practices 

for selecting, developing, or modifying 

fit-for-purpose clinical outcome 

assessments (COAs) to measure the 

patient experience in clinical trials. This 

workshop will inform development of 

patient-focused drug development 

guidance as required by the 21st 

Century Cures Act (Cures Act) and as 

part of commitments made by FDA 

under the sixth authorization of the 

Prescription Drug User Fee Act (PDUFA 

VI). FDA will publish discussion 

documents approximately 1 month 

before the workshop date. FDA is 

interested in seeking information and 

comments on the approaches proposed 

in the discussion documents. FDA is 

also interested in input on examples, 

which could be illustrated in the draft 

guidance, where the approaches 

proposed in the discussion document 

have been successfully applied. 

DATES: The public workshop will be 

held on October 15 and 16, 2018, from 

9 a.m. to 5 p.m. Submit either electronic 

or written comments on this public 

workshop by December 14, 2018. See 

the SUPPLEMENTARY INFORMATION section 

for registration date and information. 

ADDRESSES: The public workshop will 

be held at FDA’s White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993. 

Entrance for the public workshop 

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. Workshop updates, 

agenda, and discussion documents will 

be made available at: https://

www.fda.gov/Drugs/NewsEvents/ 

ucm607276.htm prior to the workshop. 

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 December 14, 2018. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of December 14, 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– 

2018–N–2455 for ‘‘Patient-Focused Drug 

Development Guidance: Methods to 

Identify What is Important to Patients 

and Select, Develop or Modify Fit-forPurpose Clinical Outcome Assessments; 

Public Workshop; 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 


sradovich on DSK3GMQ082PROD with NOTICES