Federal Register / Vol. 83, No. 135 / Friday, July 13, 2018 / Notices 32669 

allow CMS to obtain more information 

about who is submitting requests for 

ODR and whether the service or claim 

is being provided by a contract or noncontract provider. The timeliness 

requirement for ODR will also be 

eliminated to be consistent with Part D 

reporting. In addition, the number of 

data reporting elements of grievances is 

reduced from 23 to 19. The reporting 

sections for Private Fee For Service 

(PFFS) Payment Dispute Resolution 

Process and Mid-Year Network Changes 

will also be suspended. Form Number: 

CMS–10261 (OMB control number: 

0938–1054); Frequency: Yearly and 

semi-annually; Affected Public: Private 

sector (business or other for-profits); 

Number of Respondents: 432; Total 

Annual Responses: 3,024; Total Annual 

Hours: 127,329. (For policy questions 

regarding this collection contact Maria 

Sotirelis at 410–786–0552.) 

6. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: Consumer 

Assessment of Healthcare Providers and 

Systems Outpatient and Ambulatory 

Surgery (OAS CAHPS) Survey; Use: The 

information collected in the national 

implementation of Outpatient/ 

Ambulatory Surgery Patient Experience 

of Care Survey (A/ASPECS) will be used 

to: (1) Provide a source of information 

from which selected measures can be 

publicly reported to beneficiaries to 

help them make informed decisions for 

outpatient surgery facility selection; (2) 

aid facilities with their internal quality 

improvement efforts and external 

benchmarking with other facilities; and 

(3) provide us with information for 

monitoring and public reporting 

purposes. Form Number: CMS–10500 

(OMB control number: 0938–1240); 

Frequency: Once; Affected Public: 

Individuals and households; Number of 

Respondents: 633,304; Total Annual 

Responses: 633,304; Total Annual 

Hours: 153,592. (For policy questions 

regarding this collection contact 

Memuna Ifedirah at 410–786–6849). 

7. Type of Information Collection 

Request: New collection (Request for 

new OMB control number); Title of 

Information Collection: Medicare 

Enrollment Application for Physician 

and Non-Physician Practitioners; Use: 

The application is used by Medicare 

contractors to collect data to ensure that 

the applicant has the necessary 

credentials to provide the health care 

services for which they intend to bill 

Medicare, including information that 

allows the Medicare contractor to 

correctly price, process and pay the 

applicant’s claims. This application 

collects information to ensure that only 

legitimate physicians, non-physician 

practitioners, and other eligible 

professionals are enrolled in the 

Medicare program. It is meant to be the 

first line defense to protect our 

beneficiaries from illegitimate providers 

and to protect the Medicare Trust Fund 

against fraud. It also gathers information 

that allows Medicare contractors to 

ensure that the provider/supplier is not 

sanctioned from the Medicare and/or 

Medicaid program(s), or debarred, 

suspended or excluded from any other 

Federal agency or program. Form 

Number: CMS–855i (OMB control 

number: 0938–NEW); Frequency: On 

Occasion; Affected Public: State, Local, 

or Tribal Governments, Private Sector 

(not-for-profit institutions); Number of 

Respondents: 513,872; Total Annual 

Responses: 1,370,078; Total Annual 

Hours: 1,000,167. For policy questions 

regarding this collection contact 

Kimberly McPhillips at (410)-786–5374. 

Dated: July 10, 2018. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2018–15038 Filed 7–12–18; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2013–D–1156] 

Q3D(R1) Elemental Impurities; 

International Council for 

Harmonisation; 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 ‘‘Q3D(R1) 

Elemental Impurities.’’ The draft 

guidance was prepared under the 

auspices of the International Council for 

Harmonisation (ICH), formerly the 

International Conference on 

Harmonisation. The draft guidance 

revises the existing ICH guidance for 

industry ‘‘Q3D Elemental Impurities’’ 

and provides an updated permitted 

daily exposure (PDE) for the cadmium 

inhalation route of exposure. The 

updated PDE of 3 micrograms (mg)/day 

is based on a modifying factor approach 

like that used for calculating the PDEs 

for the cadmium oral and parenteral 

routes of exposure. The draft guidance 

is intended to correct a calculation error 

in the PDE for cadmium by the 

inhalation route of exposure. Following 

deliberations within the Q3D Expert 

Working Group, the revised calculation 

is based on a modifying factor approach 

that is consistent with the oral and 

parenteral PDE calculations. 

DATES: Submit either electronic or 

written comments on the draft guidance 

by August 13, 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 

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– 

2013–D–1156 for ‘‘Q3D(R1) Elemental 

Impurities.’’ Received comments will be 

placed in the docket and, except for 


sradovich on DSK3GMQ082PROD with NOTICES
32670 Federal Register / Vol. 83, No. 135 / Friday, July 13, 2018 / Notices 

those submitted as ‘‘Confidential 

Submissions,’’ publicly viewable at 

https://www.regulations.gov or at the 

Dockets Management Staff office 

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 this 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 the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research 

(CBER), 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. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–8010. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

FOR FURTHER INFORMATION CONTACT: 

Regarding the guidance: Tim McGovern, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 22, Rm. 6300, Silver Spring, 

MD 20993–0002, 240–402–0477. 

Regarding the ICH: Amanda Roache, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 51, Rm. 1176, Silver Spring, 

MD 20993–0002, 301–796–4548. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In recent years, regulatory authorities 

and industry associations from around 

the world have participated in many 

important initiatives to promote 

international harmonization of 

regulatory requirements under the ICH. 

FDA has participated in several ICH 

meetings designed to enhance 

harmonization and FDA is committed to 

seeking scientifically based harmonized 

technical procedures for pharmaceutical 

development. One of the goals of 

harmonization is to identify and reduce 

differences in technical requirements for 

drug development among regulatory 

agencies. 

ICH was established to provide an 

opportunity for harmonization 

initiatives to be developed with input 

from both regulatory and industry 

representatives. FDA also seeks input 

from consumer representatives and 

others. ICH is concerned with 

harmonization of technical 

requirements for the registration of 

pharmaceutical products for human use 

among regulators around the world. The 

six founding members of the ICH are the 

European Commission; the European 

Federation of Pharmaceutical Industries 

Associations; FDA; the Japanese 

Ministry of Health, Labour, and Welfare; 

the Japanese Pharmaceutical 

Manufacturers Association; and the 

Pharmaceutical Research and 

Manufacturers of America. The 

Standing Members of the ICH 

Association include Health Canada and 

Swissmedic. Any party eligible as a 

Member in accordance with the ICH 

Articles of Association can apply for 

membership in writing to the ICH 

Secretariat. The ICH Secretariat, which 

coordinates the preparation of 

documentation, operates as an 

international nonprofit organization and 

is funded by the Members of the ICH 

Association. 

The ICH Assembly is the overarching 

body of the Association and includes 

representatives from each of the ICH 

members and observers. The Assembly 

is responsible for the endorsement of 

draft guidelines and adoption of final 

guidelines. FDA publishes ICH 

guidelines as FDA guidance. 

In May 2018, the ICH Assembly 

endorsed the draft guideline entitled 

‘‘Q3D(R1) Elemental Impurities’’ and 

agreed that the guideline should be 

made available for public comment. The 

draft guideline is the product of the 

Quality Expert Working Group of the 

ICH. Comments about this draft will be 

considered by FDA and the Quality 

Expert Working Group. 

The draft guidance revises the 

existing guidance for industry ‘‘Q3D 

Elemental Impurities’’ and provides an 

updated permitted daily exposure (PDE) 

for the cadmium inhalation route of 

exposure. The revision was initiated 

following identification of a calculation 

error in the original text. The updated 

PDE of 3 mg/day is based on a modifying 

factor approach that is consistent with 

the method used for calculating the 

PDEs for the oral and parenteral routes 

of exposure. 

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 ‘‘Q3D(R1) Elemental Impurities.’’ 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. Electronic Access 

Persons with access to the internet 

may obtain the document at https://

www.regulations.gov, https://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/ 

Guidances/default.htm, or https://

www.fda.gov/BiologicsBloodVaccines/ 

GuidanceComplianceRegulatory

Information/Guidances/default.htm. 

Dated: July 9, 2018. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2018–14971 Filed 7–12–18; 8:45 am] 

BILLING CODE 4164–01–P 


sradovich on DSK3GMQ082PROD with NOTICES