Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices 45593 

reconsideration determination, a right to 

an ALJ hearing if the amount remaining 

in controversy after the IRE 

reconsideration meets the threshold 

amount established annually by the 

Secretary. Sections 423.1976(a) and (b) 

allow a Part D enrollee to request 

judicial review of an ALJ or Medicare 

Appeals Council decision if, in part, the 

AIC meets the threshold amount 

established annually by the Secretary. 

II. Provisions of the Notice—Annual 

AIC Adjustments 

A. AIC Adjustment Formula and AIC 

Adjustments 

As previously noted, section 940 of 

the MMA requires that the AIC 

threshold amounts be adjusted 

annually, beginning in January 2005, by 

the percentage increase in the medical 

care component of the CPI for all urban 

consumers (U.S. city average) for July 

2003 to July of the year preceding the 

year involved and rounded to the 

nearest multiple of $10. 

B. Calendar Year 2018 

The AIC threshold amount for ALJ 

hearings will remain at $160 and the 

AIC threshold amount for judicial 

review will rise to $1,600 for CY 2018. 

These amounts are based on the 59.989 

percent increase in the medical care 

component of the CPI, which was at 

297.600 in July 2003 and rose to 476.130 

in July 2017. The AIC threshold amount 

for ALJ hearings changes to $159.99 

based on the 59.989 percent increase 

over the initial threshold amount of 

$100 established in 2003. In accordance 

with section 1869(b)(1)(E)(iii) of the Act, 

the adjusted threshold amounts are 

rounded to the nearest multiple of $10. 

Therefore, the CY 2018 AIC threshold 

amount for ALJ hearings is $160.00. The 

AIC threshold amount for judicial 

review changes to $1,599.89 based on 

the 59.989 percent increase over the 

initial threshold amount of $1,000. This 

amount was rounded to the nearest 

multiple of $10, resulting in the CY 

2018 AIC threshold amount of $1,600.00 

for judicial review. 

C. Summary Table of Adjustments in 

the AIC Threshold Amounts 

In the following table we list the CYs 

2014 through 2018 threshold amounts. 

CY 2014 CY 2015 CY 2016 CY 2017 CY 2018 

ALJ Hearing ............................................................................................. $140 $150 $150 $160 $160 

Judicial Review ........................................................................................ 1,430 1,460 1,500 1,560 1,600 

III. Collection of Information 

Requirements 

This document does not impose 

information collection requirements, 

that is, reporting, recordkeeping or 

third-party disclosure requirements. 

Consequently, there is no need for 

review by the Office of Management and 

Budget under the authority of the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501 et seq.). 

Dated: September 12, 2017. 

Seema Verma, 

Administrator, Centers for Medicare & 

Medicaid Services. 

[FR Doc. 2017–20883 Filed 9–28–17; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–D–2165] 

Oncology Pharmaceuticals: 

Reproductive Toxicity Testing and 

Labeling Recommendations; 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 

‘‘Oncology Pharmaceuticals: 

Reproductive Toxicity Testing and 

Labeling Recommendations.’’ The 

purpose of this guidance is to assist 

sponsors in reproductive toxicity 

assessments (mainly of embryo-fetal 

development) for oncology 

pharmaceuticals and to provide 

recommendations for product labeling 

on duration of contraception following 

cessation of therapy to minimize 

potential risk to a developing embryo/ 

fetus. The guidance also clarifies FDA’s 

current thinking on when nonclinical 

studies for reproductive toxicology 

assessment may not be needed (e.g., for 

pharmaceuticals intended for use in 

postmenopausal women only). The 

intended outcome of this guidance is to 

provide for more consistent labeling for 

oncology pharmaceuticals and to reduce 

the conduct of nonclinical studies that 

are not informative on product use. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by November 28, 

2017. 

ADDRESSES: You may submit comments 

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): Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Division of Dockets 

Management, 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– 


asabaliauskas on DSKBBXCHB2PROD with NOTICES
45594 Federal Register / Vol. 82, No. 188 / Friday, September 29, 2017 / Notices 

2017–D–2165 for ‘‘Oncology 

Pharmaceuticals: Reproductive Toxicity 

Testing and Labeling Recommendations; 

Draft Guidance 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 

Division of Dockets Management 

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 Division of Dockets 

Management. 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 Division of Dockets 

Management, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

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. 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: John 

Leighton, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 2204, Silver Spring, 

MD 20993–0002, 301–796–0750; or 

Haleh Saber, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 2117, Silver Spring, 

MD 20993–0002, 301–796–0750. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Oncology Pharmaceuticals: 

Reproductive Toxicity Testing and 

Labeling Recommendations.’’ This 

guidance presents FDA’s current 

approach to assessing potential risks to 

embryo-fetal development associated 

with oncology pharmaceutical use in 

male and female patients. The term 

pharmaceutical in this guidance refers 

to small molecules, therapeutic 

proteins, antibodies, and related 

products such as conjugated products. 

The guidance describes when embryofetal developmental studies for oncology 

pharmaceuticals may be warranted for 

different types of pharmaceuticals, such 

as cytotoxic, biological, and conjugated 

pharmaceuticals, or pharmaceuticals 

used in combinations. The guidance 

also discusses other aspects of a 

nonclinical reproductive toxicity 

evaluation, such as fertility and pre- and 

postnatal evaluation. The guidance 

addresses the need for a reproductive 

toxicity evaluation when 

pharmaceuticals are used in specific 

populations (e.g., pediatric, males-only, 

or postmenopausal women). 

Although current regulatory 

guidances exist regarding the need to 

assess the embryo-fetal developmental 

toxicity potential of pharmaceuticals 

and the overall design of the studies, 

this guidance provides additional 

recommendations on specific types of 

products and for specific populations, 

which are not covered under other 

guidances. In addition, this guidance 

provides recommendations on the use of 

contraception and the duration of its use 

to minimize the potential risks 

associated with the use of oncology 

pharmaceuticals. 

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 reproductive toxicity testing and 

labeling recommendations for oncology 

pharmaceuticals. 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 is not a 

significant regulatory action subject to 

Executive Order 12866. 

II. The Paperwork Reduction Act of 

1995 

This guidance refers to previously 

approved collections of information that 

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 parts 312 and 

314 have been approved under OMB 

control numbers 0910–0014 and 0910– 

0001, respectively. The collections of 

information in 21 CFR 201.56, 201.57, 

and the final rule ‘‘Content and Format 

of Labeling for Human Prescription 

Drug and Biological Products; 

Requirements for Pregnancy and 

Lactation Labeling’’ have been approved 

under OMB control numbers 0910–0572 

and 0910–0624. 

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: September 22, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–20906 Filed 9–28–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–4644] 

Advancement of Emerging Technology 

Applications for Pharmaceutical 

Innovation and Modernization; 

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 

guidance for industry entitled 

‘‘Advancement of Emerging Technology 

Applications for Pharmaceutical 

Innovation and Modernization.’’ This 

guidance finalizes the draft guidance 


asabaliauskas on DSKBBXCHB2PROD with NOTICES