43876 Federal Register / Vol. 83, No. 167 / Tuesday, August 28, 2018 / Notices 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

International panel physicians ........................ TB Indicators Excel Spreadsheet .................. 336 1 3 

Jeffrey M. Zirger, 

Acting Chief, Information Collection Review 

Office, Office of Scientific Integrity, Office 

of the Associate Director for Science, Office 

of the Director, Centers for Disease Control 

and Prevention. 

[FR Doc. 2018–18588 Filed 8–27–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[60Day–18–0600; Docket No. CDC–CDC– 

2008–0079] 

Proposed Data Collection Submitted 

for Public Comment and 

Recommendations 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice with comment period. 

SUMMARY: The Centers for Disease 

Control and Prevention (CDC), as part of 

its continuing effort to reduce public 

burden and maximize the utility of 

government information, invites the 

general public and other Federal 

agencies the opportunity to comment on 

a proposed and/or continuing 

information collection, as required by 

the Paperwork Reduction Act of 1995. 

This notice invites comment on a 

proposed information collection project 

titled CDC Model Performance 

Evaluation Program (MPEP) for 

Mycobacterium tuberculosis 

Susceptibility Testing information 

collection. CDC is requesting a threeyear approval for revision to the 

previously approved project used to 

monitor and evaluate performances and 

practices among national laboratories M. 

tuberculosis susceptibility testing. 

DATES: CDC must receive written 

comments on or before October 29, 

2018. 

ADDRESSES: You may submit comments, 

identified by Docket No. CDC–2008– 

00791 by any of the following methods: 

• Federal eRulemaking Portal: 

Regulations.gov. Follow the instructions 

for submitting comments. 

• Mail: Jeffrey M. Zirger, Information 

Collection Review Office, Centers for 

Disease Control and Prevention, 1600 

Clifton Road NE, MS–D74, Atlanta, 

Georgia 30329. 

Instructions: All submissions received 

must include the agency name and 

Docket Number. CDC will post, without 

change, all relevant comments to 

Regulations.gov. 

Please note: Submit all comments 

through the Federal eRulemaking portal 

(regulations.gov) or by U.S. mail to the 

address listed above. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on the 

proposed project or to obtain a copy of 

the information collection plan and 

instruments, contact Jeffery M. Zirger, 

Information Collection Review Office, 

Centers for Disease Control and 

Prevention, 1600 Clifton Road NE, MS– 

D74, Atlanta, Georgia 30329; phone: 

404–639–7570; Email: omb@cdc.gov. 

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. In addition, the PRA also 

requires Federal agencies to provide a 

60-day notice in the Federal Register 

concerning each proposed collection of 

information, including each new 

proposed collection, each proposed 

extension of existing collection of 

information, and each reinstatement of 

previously approved information 

collection before submitting the 

collection to the OMB for approval. To 

comply with this requirement, we are 

publishing this notice of a proposed 

data collection as described below. 

The OMB is particularly interested in 

comments that will help: 

1. Evaluate whether the proposed 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information will have 

practical utility; 

2. Evaluate the accuracy of the 

agency’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

3. Enhance the quality, utility, and 

clarity of the information to be 

collected; and 

4. Minimize the burden of the 

collection of information on those who 

are to respond, including through the 

use of appropriate automated, 

electronic, mechanical, or other 

technological collection techniques or 

other forms of information technology, 

e.g., permitting electronic submissions 

of responses. 

5. Assess information collection costs. 

Proposed Project 

CDC Model Performance Evaluation 

Program (MPEP) for Mycobacterium 

tuberculosis Susceptibility testing (OMB 

#0920–0600, expiration 3/31/2019)— 

Revision—National Center for HIV/ 

AIDS, Viral Hepatitis, STD, and TB 

Prevention (NCHHSTP), Centers for 

Disease Control and Prevention (CDC). 

Background and Brief Description 

The CDC is requesting a revision to 

the approved information collection, 

CDC Model Performance for 

Mycobacterium tuberculosis Drug 

Susceptibility Testing (OMB Control 

Number 0920–0600). Clearance is 

requested for a period of three years. 

Revision of this information collection 

will not require changes in the scope of 

the study. This revision includes (a) 

modification of the Participant Biosafety 

Compliance Letter of Agreement; (b) 

modification of the Instructions to 

Participants Letter; (c) modification of 

the MPEP Mycobacterium Results 

Worksheet; (d) Request for approval of 

a MPEP Mycobacterium tuberculosis 

Minimum Inhibitory Concentration 

(MIC) Results Form for laboratories that 

perform Sensititre Drug Susceptibility 

Testing (DST) to record MIC results; and 

(e) reduction in request for burden 

hours. 

While the overall number of cases of 

TB in the U.S. has decreased, rates still 

remain high among foreign-born 

persons, prisoners, homeless 

populations, and individuals infected 

with HIV in major metropolitan areas. 

To reach the goal of eliminating TB, the 

Model Performance Evaluation Program 

for Mycobacterium tuberculosis 

Susceptibility Testing is used to monitor 

and evaluate performance and practices 

among national laboratories performing 

M. tuberculosis susceptibility testing. 

Participation in this program is one way 


daltland on DSKBBV9HB2PROD with NOTICES
Federal Register / Vol. 83, No. 167 / Tuesday, August 28, 2018 / Notices 43877 

laboratories can ensure high-quality 

laboratory testing, resulting in accurate 

and reliable testing results. 

By providing an evaluation program 

to assess the ability of the laboratories 

to test for drug resistant M. tuberculosis 

strains, laboratories also have a selfassessment tool to aid in optimizing 

their skills in susceptibility testing. The 

information obtained from the 

laboratories on susceptibility practices 

and procedures is used to establish 

variables related to good performance, 

assessing training needs, and aid with 

the development of practice standards. 

Participants in this program include 

domestic clinical and public health 

laboratories. Data collection from 

laboratory participants occurs twice per 

year. The data collected in this program 

will include the susceptibility test 

results of primary and secondary drugs, 

drug concentrations, and test methods 

performed by laboratories on a set of 

performance evaluation (PE) samples. 

The PE samples are sent to participants 

twice a year. Participants also report 

demographic data such as laboratory 

type and the number of tests performed 

annually. The total estimated annual 

burden hours are 129. There is no cost 

to respondents to participate other than 

their time. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of 

respondents Form name Number of respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Total burden 

(in hours) 

Domestic Laboratory ......................... Participant Biosafety Compliance 

Letter of Agreement.

80 1 5/60 7 

MPEP Mycobacterium tuberculosis 

Results Worksheet.

80 2 30/60 80 

Online Survey Instrument ................ 80 2 15/60 40 

MPEP Mycobacterium tuberculosis 

Minimum Inhibitory Concentration 

Results Form.

4 2 15/60 2 

Total ........................................... ........................................................... ........................ ........................ ........................ 129 

Jeffrey M. Zirger, 

Acting Chief, Information Collection Review 

Office, Office of Scientific Integrity, Office 

of the Associate Director for Science, Office 

of the Director, Centers for Disease Control 

and Prevention. 

[FR Doc. 2018–18589 Filed 8–27–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–N–3240] 

List of Bulk Drug Substances for 

Which There is a Clinical Need Under 

Section 503B of the Federal Food, 

Drug, and Cosmetic Act 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

developing a list of bulk drug 

substances (active pharmaceutical 

ingredients) for which there is a clinical 

need (the 503B Bulks List). Drug 

products that outsourcing facilities 

compound using bulk drug substances 

on the 503B Bulks List qualify for 

certain exemptions from the Federal 

Food, Drug, and Cosmetic Act (FD&C 

Act) provided certain conditions are 

met. This notice identifies three bulk 

drug substances that FDA has 

considered and is proposing not to 

include on the list: Bumetanide, 

nicardipine hydrochloride, and 

vasopressin. Additional bulk drug 

substances nominated by the public for 

inclusion on this list are currently under 

consideration and will be the subject of 

future notices. 

DATES: Submit either electronic or 

written comments on the notice by 

October 29, 2018 to ensure that the 

Agency considers your comment on this 

notice before it begins work on a notice 

reflecting the Agency’s final decision 

about whether to include these 

substances on the 503B Bulks List. 

ADDRESSES: You may submit comments 

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– 

2018–N–3240 for ‘‘List of Bulk Drug 

Substances For Which There Is a 

Clinical Need Under Section 503B of the 

Federal Food, Drug, and Cosmetic Act.’’ 

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 


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