35646 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 

variability in success rates across ART 

programs and individuals. 

Each ART program reports its annual 

ART cycle data to CDC in midDecember. The annual data reporting 

consists of information about all ART 

cycles that were initiated in the 

previous calendar year. For example, 

the December 2017 reports described 

ART cycles that were initiated between 

January 1, 2016, and December 31, 2016. 

Data elements and definitions currently 

in use reflect CDC’s prior consultations 

with representatives of the Society for 

Assisted Reproductive Technology 

(SART), the American Society for 

Reproductive Medicine, and RESOLVE: 

The National Infertility Association (a 

national, nonprofit consumer 

organization), as well as a variety of 

individuals with expertise and interest 

in this field. 

The estimated number of respondents 

(ART programs or clinics) is 464, based 

on the number of clinics that provided 

information in 2015; the estimated 

average number of responses (ART 

cycles) per respondent is 350. 

Additionally, approximately 5–10% of 

responding clinics will be randomly 

selected each year to participate in data 

validation and quality control activities; 

an estimated 35 clinics will be selected 

to report validation data on 70 cycles 

each on average. Finally, respondents 

may provide feedback to CDC about the 

usability and utility of the reporting 

system. The option to participate in the 

feedback survey is presented to 

respondents when they complete their 

required data submission. Participation 

in the feedback survey is voluntary and 

is not required by the FCSRCA. CDC 

estimates that 75% of ART programs 

will participate in the feedback survey. 

The collection of ART cycle 

information allows CDC to publish an 

annual report to Congress as specified 

by the FCSRCA and to provide 

information needed by consumers. OMB 

approval is requested for three years. 

The estimated annualized Burden Hours 

are 114,631 which is a decrease of 1,794 

from the current OMB-approved 

collection. There are no costs to 

respondents 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) 

ART Clinics ..................................................... NASS .............................................................. 464 350 42/60 

Data Validation ............................................... 35 70 23/60 

Feedback Survey ........................................... 348 1 2/60 

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. 2018–16091 Filed 7–26–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

[30Day–18–0222] 

Agency Forms Undergoing Paperwork 

Reduction Act Review 

In accordance with the Paperwork 

Reduction Act of 1995, the Centers for 

Disease Control and Prevention (CDC) 

has submitted the information 

collection request titled Collaborating 

Center for Questionnaire Design and 

Evaluation Research (CCQDER), to the 

Office of Management and Budget 

(OMB) for review and approval. CDC 

previously published a ‘‘Proposed Data 

Collection Submitted for Public 

Comment and Recommendations’’ 

notice on March 1, 2018 to obtain 

comments from the public and affected 

agencies. CDC did not receive comments 

related to the previous notice. This 

notice serves to allow an additional 30 

days for public and affected agency 

comments. 

CDC will accept all comments for this 

proposed information collection project. 

The Office of Management and Budget 

is particularly interested in comments 

that: 

(a) 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; 

(b) Evaluate the accuracy of the 

agencies estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; 

(c) Enhance the quality, utility, and 

clarity of the information to be 

collected; 

(d) 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 submission of 

responses; and 

(e) Assess information collection 

costs. 

To request additional information on 

the proposed project or to obtain a copy 

of the information collection plan and 

instruments, call (404) 639–7570 or 

send an email to omb@cdc.gov. Direct 

written comments and/or suggestions 

regarding the items contained in this 

notice to the Attention: CDC Desk 

Officer, Office of Management and 

Budget, 725 17th Street NW, 

Washington, DC 20503 or by fax to (202) 

395–5806. Provide written comments 

within 30 days of notice publication. 

Proposed Project 

Collaborating Center for Questionnaire 

Design and Evaluation Research 

(CCQDER) (OMB Control Number 0920– 

0222, Expiration 07/31/2018)— 

Revision—National Center for Health 

Statistics (NCHS), Centers for Disease 

Control and Prevention (CDC) 

Background and Brief Description 

Section 306 of the Public Health 

Service (PHS) Act (42 U.S.C. 242k), as 

amended, authorizes that the Secretary 

of Health and Human Services (DHHS), 

acting through NCHS, shall undertake 

and support (by grant or contract) 

research, demonstrations, and 

evaluations respecting new or improved 

methods for obtaining current data to 

support statistical and epidemiological 

activities for the purpose of improving 

the effectiveness, efficiency, and quality 

of health services in the United States. 

The Collaborating Center for 

Questionnaire Design and Evaluation 

Research (CCQDER) is the focal point 

within NCHS for questionnaire and 

survey development, pre-testing, and 

evaluation activities for CDC surveys 

(such as the NCHS National Health 


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Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 35647 

Interview Survey, OMB No. 0920–0214) 

and other federally sponsored surveys. 

NCHS is requesting 3 years of OMB 

Clearance for this generic submission. 

The CCQDER and other NCHS 

programs conduct cognitive interviews, 

focus groups, in-depth or ethnographic 

interviews, usability tests, field tests/ 

pilot interviews, and experimental 

research in laboratory and field settings, 

both for applied questionnaire 

development and evaluation as well as 

more basic research on measurement 

errors and survey response. 

Various techniques to evaluate 

interviewer administered, selfadministered, telephone, Computer 

Assisted Personal Interviewing (CAPI), 

Computer Assisted Self-Interviewing 

(CASI), Audio Computer-Assisted SelfInterviewing (ACASI), and web-based 

questionnaires are used. 

The most common questionnaire 

evaluation method is the cognitive 

interview. These evaluations are 

conducted by the CCQDER and 

contractors, as needed. The interview 

structure consists of respondents first 

answering a draft survey question and 

then providing textual information to 

reveal the processes involved in 

answering the test question. 

Specifically, cognitive interview 

respondents are asked to describe how 

and why they answered the question as 

they did. Through the interviewing 

process, various types of questionresponse problems that would not 

normally be identified in a traditional 

survey interview, such as interpretive 

errors and recall accuracy, are 

uncovered. By conducting a 

comparative analysis of cognitive 

interviews, it is also possible to 

determine whether particular 

interpretive patterns occur within 

particular sub-groups of the population. 

Interviews are generally conducted in 

small rounds totaling 40–100 

interviews; ideally, the questionnaire is 

re-worked between rounds, and 

revisions are tested iteratively until 

interviews yield relatively few new 

insights. 

Cognitive interviewing is inexpensive 

and provides useful data on 

questionnaire performance while 

minimizing respondent burden. 

Cognitive interviewing offers a detailed 

depiction of meanings and processes 

used by respondents to answer 

questions—processes that ultimately 

produce the survey data. As such, the 

method offers an insight that can 

transform understanding of question 

validity and response error. 

Documented findings from these studies 

represent tangible evidence of how the 

question performs. Such documentation 

also serves CDC data users, allowing 

them to be critical users in their 

approach and application of the data. 

In addition to cognitive interviewing, 

a number of other qualitative and 

quantitative methods are used to 

investigate and research measurement 

error and the survey response process. 

These methods include conducting 

focus groups, usability tests, in-depth or 

ethnographic interviews, and the 

administration and analysis of questions 

in both representative and nonrepresentative field tests. Focus groups 

are conducted by the CCQDER and 

contractors, as needed. They are group 

discussions whose primary purpose is 

to elicit the basic sociocultural 

understandings and terminology that 

form the basis of questionnaire design. 

Each group typically consists of one 

moderator and 4 to 10 participants, 

depending on the research question. Indepth or ethnographic interviews are 

one-on-one interviews designed to elicit 

the understandings or terminology that 

are necessary for question design, as 

well as to gather detailed information 

that can contribute to the analysis of 

both qualitative and quantitative data. 

Usability tests are typically one-on-one 

interviews that are used to determine 

how a given survey or information 

collection tool functions in the field, 

and how the mode and layout of the 

instrument itself may contribute to 

survey response error and the survey 

response process. 

In addition to these qualitative 

methods, NCHS also uses various tools 

to obtain quantitative data, which can 

be analyzed alone or analyzed alongside 

qualitative data to give a much fuller 

accounting of the survey response 

process. For instance, phone, internet, 

mail, and in-person follow-up 

interviews of previous NCHS survey 

respondents may be used to test the 

validity of survey questions and 

questionnaires and to obtain more 

detailed information that cannot be 

gathered on the original survey. 

Additionally, field or pilot tests may be 

conducted on both representative and 

non-representative samples, including 

those obtained from commercial survey 

and web panel vendors. Beyond looking 

at traditional measures of survey errors 

(such as item missing and non-response 

rates, and response latency), these pilot 

tests can be used to run experimental 

designs in order to capture how 

different questions function in a field 

setting. 

Similar methodology has been 

adopted by other federal agencies, as 

well as by academic and commercial 

survey organizations. There are no costs 

to respondents other than their time. 

The total estimated annual burden 

hours are 7,783. 

ESTIMATED ANNUALIZED BURDEN HOURS

Type of respondents Form name Number of 

respondents 

Number of 

responses per 

respondent 

Average 

burden per 

response 

(in hours) 

Individuals or households ............................... Eligibility Screening ........................................ 4,000 1 5/60 

Individuals or households ............................... Questionnaire Development Studies ............. 7,300 1 55/60 

Individuals or households ............................... Respondent Data Collection Sheet ................ 7,300 1 5/60 

Individuals or households ............................... Focus groups ................................................. 100 1 90/60 


amozie on DSK3GDR082PROD with NOTICES1
35648 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices 

Jeffery 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. 2018–16090 Filed 7–26–18; 8:45 am] 

BILLING CODE 4163–18–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Disease Control and 

Prevention 

Advisory Committee to the Director 

(ACD), Centers for Disease Control and 

Prevention (CDC)—Health Disparities 

Subcommittee (HDS) 

AGENCY: Centers for Disease Control and 

Prevention (CDC), Department of Health 

and Human Services (HHS). 

ACTION: Notice of meeting. 

SUMMARY: In accordance with the 

Federal Advisory Committee Act, the 

CDC announces the following meeting 

for the Advisory Committee to the 

Director, Centers for Disease Control 

and Prevention—Health Disparities 

Subcommittee (ACD, CDC–HDS). This 

meeting is open to the public, limited 

only by the 50 audio phone lines. The 

public is also welcome to listen to the 

meeting by teleconference. Please dial 

(866) 918–8397 and enter code 9346283. 

There are 50 lines available. The public 

comment period is from 3:15 p.m.–3:20 

p.m. 

DATES: The meeting will be held on 

October 9, 2018, 1:30 p.m. to 3:30 p.m., 

EDT. 

ADDRESSES: Teleconference phone 

(866) 918–8397 and enter code 9346283. 

FOR FURTHER INFORMATION CONTACT: 

Leandris Liburd, Ph.D., M.P.H., M.A., 

Designated Federal Officer, Health 

Disparities Subcommittee, Advisory 

Committee to the Director, CDC, 1600 

Clifton Road NE, M/S K–77, Atlanta, 

Georgia 30329. Telephone (404) 498– 

6482, Email: ACDirector@cdc.gov. 

SUPPLEMENTARY INFORMATION: 

Purpose: The Subcommittee will 

provide counsel to the CDC Director 

through the ACD on strategic and other 

health disparities and health equity 

issues and provide guidance on 

opportunities for CDC. 

Matters to be Considered: The agenda 

will include discussions on new 

member orientation. This meeting will 

provide information to new members 

regarding their role & duties on this 

subcommittee. Agenda items are subject 

to change as priorities dictate. 

The Director, Management Analysis 

and Services Office, has been delegated 

the authority to sign Federal Register 

notices pertaining to announcements of 

meetings and other committee 

management activities, for both the 

Centers for Disease Control and 

Prevention and the Agency for Toxic 

Substances and Disease Registry. 

Dia Taylor, 

Acting Chief Operating Officer, Centers for 

Disease Control and Prevention. 

[FR Doc. 2018–16103 Filed 7–26–18; 8:45 am] 

BILLING CODE 4163–19–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2018–P–1283] 

Determination That Metaxalone 

Tablets, 640 Milligrams, Were Not 

Withdrawn From Sale for Reasons of 

Safety or Effectiveness 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) has 

determined that metaxalone tablets, 640 

milligrams (mg), were not withdrawn 

from sale for reasons of safety or 

effectiveness. This determination will 

allow FDA to approve abbreviated new 

drug applications (ANDAs) for 

metaxalone tablets, 640 mg, if all other 

legal and regulatory requirements are 

met. 

FOR FURTHER INFORMATION CONTACT: Glen 

Cheng, Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave. Bldg. 51, Rm. 6217, Silver Spring, 

MD 20993–0002, 301–796–1494. 

SUPPLEMENTARY INFORMATION: In 1984, 

Congress enacted the Drug Price 

Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

(the 1984 amendments), which 

authorized the approval of duplicate 

versions of drug products under an 

ANDA procedure. ANDA applicants 

must, with certain exceptions, show that 

the drug for which they are seeking 

approval contains the same active 

ingredient in the same strength and 

dosage form as the ‘‘listed drug,’’ which 

is a version of the drug that was 

previously approved. ANDA applicants 

do not have to repeat the extensive 

clinical testing otherwise necessary to 

gain approval of a new drug application 

(NDA). 

The 1984 amendments include what 

is now section 505(j)(7) of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

355(j)(7)), which requires FDA to 

publish a list of all approved drugs. 

FDA publishes this list as part of the 

‘‘Approved Drug Products With 

Therapeutic Equivalence Evaluations,’’ 

which is known generally as the 

‘‘Orange Book.’’ Under FDA regulations, 

drugs are removed from the list if the 

Agency withdraws or suspends 

approval of the drug’s NDA or ANDA 

for reasons of safety or effectiveness or 

if FDA determines that the listed drug 

was withdrawn from sale for reasons of 

safety or effectiveness (21 CFR 314.162). 

A person may petition the Agency to 

determine, or the Agency may 

determine on its own initiative, whether 

a listed drug was withdrawn from sale 

for reasons of safety or effectiveness. 

This determination may be made at any 

time after the drug has been withdrawn 

from sale, but must be made prior to 

approving an ANDA that refers to the 

listed drug (§ 314.161 (21 CFR 314.161)). 

FDA may not approve an ANDA that 

does not refer to a listed drug. 

Metaxalone tablets, 640 mg, are the 

subject of NDA 22–503, held by Primus 

Pharmaceuticals, Inc., and initially 

approved on June 1, 2015. Metaxalone 

tablets, 640 mg, are indicated as an 

adjunct to rest, physical therapy, and 

other measures for the relief of 

discomfort associated with acute, 

painful musculoskeletal conditions. 

In a letter dated September 30, 2015, 

the previous NDA holder CorePharma, 

LLC notified FDA that metaxalone 

tablets, 640 mg, were discontinued, and 

FDA moved the drug product to the 

‘‘Discontinued Drug Product List’’ 

section of the Orange Book. 

Sovereign Pharmaceuticals, LLC 

submitted a citizen petition dated 

March 26, 2018 (Docket No. FDA–2018– 

P–1283), under 21 CFR 10.30, 

requesting that the Agency determine 

whether metaxalone tablets, 640 mg, 

were withdrawn from sale for reasons of 

safety or effectiveness. 

After considering the citizen petition 

and reviewing Agency records and 

based on the information we have at this 

time, FDA has determined under 

§ 314.161 that metaxalone tablets, 640 

mg, were not withdrawn for reasons of 

safety or effectiveness. The petitioner 

has identified no data or other 

information suggesting that metaxalone 

tablets, 640 mg, were withdrawn for 

reasons of safety or effectiveness. We 

have carefully reviewed our files for 

records concerning the withdrawal of 

metaxalone tablets, 640 mg, from sale. 

We have also independently evaluated 

relevant literature and data for possible 

postmarketing adverse events. We have 

reviewed the available evidence and 

determined that this drug product was 


amozie on DSK3GDR082PROD with NOTICES1