83 FR 35646 - Agency Forms Undergoing Paperwork Reduction Act Review
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention Federal Register Volume 83, Issue 145 (July 27, 2018)
Centers for Disease Control and Prevention
Federal Register Volume 83, Issue 145 (July 27, 2018)
| Page Range | 35646-35648 | |
| FR Document | 2018-16090 |
[Federal Register Volume 83, Number 145 (Friday, July 27, 2018)] [Notices] [Pages 35646-35648] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-16090] ----------------------------------------------------------------------- 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 [[Page 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, self- administered, telephone, Computer Assisted Personal Interviewing (CAPI), Computer Assisted Self-Interviewing (CASI), Audio Computer- Assisted Self-Interviewing (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 question-response 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 non-representative 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. In-depth 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 ---------------------------------------------------------------------------------------------------------------- Number of Average burden Type of respondents Form name Number of responses per per response respondents respondent (in hours) ---------------------------------------------------------------------------------------------------------------- Individuals or households............. Eligibility Screening... 4,000 1 5/60 Individuals or households............. Questionnaire 7,300 1 55/60 Development Studies. Individuals or households............. Respondent Data 7,300 1 5/60 Collection Sheet. Individuals or households............. Focus groups............ 100 1 90/60 ---------------------------------------------------------------------------------------------------------------- [[Page 35648]] 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
![35646 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices
variability in success rates across ART organization), as well as a variety of feedback survey is presented to
programs and individuals. individuals with expertise and interest respondents when they complete their
Each ART program reports its annual in this field. required data submission. Participation
ART cycle data to CDC in mid- The estimated number of respondents in the feedback survey is voluntary and
December. The annual data reporting (ART programs or clinics) is 464, based is not required by the FCSRCA. CDC
consists of information about all ART on the number of clinics that provided estimates that 75% of ART programs
cycles that were initiated in the information in 2015; the estimated will participate in the feedback survey.
previous calendar year. For example, average number of responses (ART
the December 2017 reports described cycles) per respondent is 350. The collection of ART cycle
ART cycles that were initiated between Additionally, approximately 5–10% of information allows CDC to publish an
January 1, 2016, and December 31, 2016. responding clinics will be randomly annual report to Congress as specified
Data elements and definitions currently selected each year to participate in data by the FCSRCA and to provide
in use reflect CDC’s prior consultations validation and quality control activities; information needed by consumers. OMB
with representatives of the Society for an estimated 35 clinics will be selected approval is requested for three years.
Assisted Reproductive Technology to report validation data on 70 cycles The estimated annualized Burden Hours
(SART), the American Society for each on average. Finally, respondents are 114,631 which is a decrease of 1,794
Reproductive Medicine, and RESOLVE: may provide feedback to CDC about the from the current OMB-approved
The National Infertility Association (a usability and utility of the reporting collection. There are no costs to
national, nonprofit consumer system. The option to participate in the respondents other than their time.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of Average
Number of responses burden per
Type of respondents Form name respondents per response
respondent (in hours)
ART Clinics ..................................................... NASS .............................................................. 464 350 42/60
Data Validation ............................................... 35 70 23/60
Feedback Survey ........................................... 348 1 2/60
Jeffrey M. Zirger, days for public and affected agency regarding the items contained in this
Acting Chief, Information Collection Review comments. notice to the Attention: CDC Desk
Office, Office of Scientific Integrity, Office CDC will accept all comments for this Officer, Office of Management and
of the Associate Director for Science, Office proposed information collection project. Budget, 725 17th Street NW,
of the Director, Centers for Disease Control The Office of Management and Budget Washington, DC 20503 or by fax to (202)
and Prevention. is particularly interested in comments 395–5806. Provide written comments
[FR Doc. 2018–16091 Filed 7–26–18; 8:45 am] that: within 30 days of notice publication.
BILLING CODE 4163–18–P (a) Evaluate whether the proposed
collection of information is necessary Proposed Project
for the proper performance of the Collaborating Center for Questionnaire
DEPARTMENT OF HEALTH AND functions of the agency, including Design and Evaluation Research
HUMAN SERVICES whether the information will have (CCQDER) (OMB Control Number 0920–
practical utility; 0222, Expiration 07/31/2018)—
Centers for Disease Control and (b) Evaluate the accuracy of the Revision—National Center for Health
Prevention agencies estimate of the burden of the Statistics (NCHS), Centers for Disease
proposed collection of information, Control and Prevention (CDC)
[30Day–18–0222] including the validity of the
Background and Brief Description
methodology and assumptions used;
Agency Forms Undergoing Paperwork (c) Enhance the quality, utility, and Section 306 of the Public Health
Reduction Act Review clarity of the information to be Service (PHS) Act (42 U.S.C. 242k), as
collected; amended, authorizes that the Secretary
In accordance with the Paperwork (d) Minimize the burden of the of Health and Human Services (DHHS),
Reduction Act of 1995, the Centers for collection of information on those who acting through NCHS, shall undertake
Disease Control and Prevention (CDC) are to respond, including, through the and support (by grant or contract)
has submitted the information use of appropriate automated, research, demonstrations, and
collection request titled Collaborating electronic, mechanical, or other evaluations respecting new or improved
Center for Questionnaire Design and technological collection techniques or methods for obtaining current data to
Evaluation Research (CCQDER), to the other forms of information technology, support statistical and epidemiological
Office of Management and Budget e.g., permitting electronic submission of activities for the purpose of improving
(OMB) for review and approval. CDC responses; and the effectiveness, efficiency, and quality
previously published a ‘‘Proposed Data (e) Assess information collection of health services in the United States.
amozie on DSK3GDR082PROD with NOTICES1
Collection Submitted for Public costs. The Collaborating Center for
Comment and Recommendations’’ To request additional information on Questionnaire Design and Evaluation
notice on March 1, 2018 to obtain the proposed project or to obtain a copy Research (CCQDER) is the focal point
comments from the public and affected of the information collection plan and within NCHS for questionnaire and
agencies. CDC did not receive comments instruments, call (404) 639–7570 or survey development, pre-testing, and
related to the previous notice. This send an email to omb@cdc.gov. Direct evaluation activities for CDC surveys
notice serves to allow an additional 30 written comments and/or suggestions (such as the NCHS National Health
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![35648 Federal Register / Vol. 83, No. 145 / Friday, July 27, 2018 / Notices
Jeffery M. Zirger, the authority to sign Federal Register 355(j)(7)), which requires FDA to
Acting Chief, Information Collection Review notices pertaining to announcements of publish a list of all approved drugs.
Office, Office of Scientific Integrity, Office meetings and other committee FDA publishes this list as part of the
of the Associate Director for Science, Office management activities, for both the ‘‘Approved Drug Products With
of the Director, Centers for Disease Control Centers for Disease Control and Therapeutic Equivalence Evaluations,’’
and Prevention.
Prevention and the Agency for Toxic which is known generally as the
[FR Doc. 2018–16090 Filed 7–26–18; 8:45 am] ‘‘Orange Book.’’ Under FDA regulations,
Substances and Disease Registry.
BILLING CODE 4163–18–P drugs are removed from the list if the
Dia Taylor,
Agency withdraws or suspends
Acting Chief Operating Officer, Centers for approval of the drug’s NDA or ANDA
DEPARTMENT OF HEALTH AND Disease Control and Prevention.
for reasons of safety or effectiveness or
HUMAN SERVICES [FR Doc. 2018–16103 Filed 7–26–18; 8:45 am] if FDA determines that the listed drug
Centers for Disease Control and
BILLING CODE 4163–19–P was withdrawn from sale for reasons of
Prevention safety or effectiveness (21 CFR 314.162).
A person may petition the Agency to
DEPARTMENT OF HEALTH AND determine, or the Agency may
Advisory Committee to the Director HUMAN SERVICES
(ACD), Centers for Disease Control and determine on its own initiative, whether
Prevention (CDC)—Health Disparities a listed drug was withdrawn from sale
Food and Drug Administration for reasons of safety or effectiveness.
Subcommittee (HDS)
[Docket No. FDA–2018–P–1283] This determination may be made at any
AGENCY: Centers for Disease Control and time after the drug has been withdrawn
Prevention (CDC), Department of Health Determination That Metaxalone from sale, but must be made prior to
and Human Services (HHS). Tablets, 640 Milligrams, Were Not approving an ANDA that refers to the
ACTION: Notice of meeting. Withdrawn From Sale for Reasons of listed drug (§ 314.161 (21 CFR 314.161)).
Safety or Effectiveness FDA may not approve an ANDA that
SUMMARY: In accordance with the does not refer to a listed drug.
Federal Advisory Committee Act, the AGENCY: Food and Drug Administration,
Metaxalone tablets, 640 mg, are the
CDC announces the following meeting HHS.
subject of NDA 22–503, held by Primus
for the Advisory Committee to the ACTION: Notice. Pharmaceuticals, Inc., and initially
Director, Centers for Disease Control approved on June 1, 2015. Metaxalone
and Prevention—Health Disparities SUMMARY: The Food and Drug
Administration (FDA or Agency) has tablets, 640 mg, are indicated as an
Subcommittee (ACD, CDC–HDS). This adjunct to rest, physical therapy, and
meeting is open to the public, limited determined that metaxalone tablets, 640
milligrams (mg), were not withdrawn other measures for the relief of
only by the 50 audio phone lines. The discomfort associated with acute,
public is also welcome to listen to the from sale for reasons of safety or
effectiveness. This determination will painful musculoskeletal conditions.
meeting by teleconference. Please dial In a letter dated September 30, 2015,
(866) 918–8397 and enter code 9346283. allow FDA to approve abbreviated new
drug applications (ANDAs) for the previous NDA holder CorePharma,
There are 50 lines available. The public LLC notified FDA that metaxalone
comment period is from 3:15 p.m.–3:20 metaxalone tablets, 640 mg, if all other
legal and regulatory requirements are tablets, 640 mg, were discontinued, and
p.m. FDA moved the drug product to the
DATES: The meeting will be held on
met.
‘‘Discontinued Drug Product List’’
October 9, 2018, 1:30 p.m. to 3:30 p.m., FOR FURTHER INFORMATION CONTACT: Glen section of the Orange Book.
EDT. Cheng, Center for Drug Evaluation and Sovereign Pharmaceuticals, LLC
ADDRESSES: Teleconference phone Research, Food and Drug submitted a citizen petition dated
(866) 918–8397 and enter code 9346283. Administration, 10903 New Hampshire March 26, 2018 (Docket No. FDA–2018–
FOR FURTHER INFORMATION CONTACT: Ave. Bldg. 51, Rm. 6217, Silver Spring, P–1283), under 21 CFR 10.30,
Leandris Liburd, Ph.D., M.P.H., M.A., MD 20993–0002, 301–796–1494. requesting that the Agency determine
Designated Federal Officer, Health SUPPLEMENTARY INFORMATION: In 1984, whether metaxalone tablets, 640 mg,
Disparities Subcommittee, Advisory Congress enacted the Drug Price were withdrawn from sale for reasons of
Committee to the Director, CDC, 1600 Competition and Patent Term safety or effectiveness.
Clifton Road NE, M/S K–77, Atlanta, Restoration Act of 1984 (Pub. L. 98–417) After considering the citizen petition
Georgia 30329. Telephone (404) 498– (the 1984 amendments), which and reviewing Agency records and
6482, Email: ACDirector@cdc.gov. authorized the approval of duplicate based on the information we have at this
SUPPLEMENTARY INFORMATION: versions of drug products under an time, FDA has determined under
Purpose: The Subcommittee will ANDA procedure. ANDA applicants § 314.161 that metaxalone tablets, 640
provide counsel to the CDC Director must, with certain exceptions, show that mg, were not withdrawn for reasons of
through the ACD on strategic and other the drug for which they are seeking safety or effectiveness. The petitioner
health disparities and health equity approval contains the same active has identified no data or other
issues and provide guidance on ingredient in the same strength and information suggesting that metaxalone
opportunities for CDC. dosage form as the ‘‘listed drug,’’ which tablets, 640 mg, were withdrawn for
Matters to be Considered: The agenda is a version of the drug that was reasons of safety or effectiveness. We
will include discussions on new previously approved. ANDA applicants have carefully reviewed our files for
amozie on DSK3GDR082PROD with NOTICES1
member orientation. This meeting will do not have to repeat the extensive records concerning the withdrawal of
provide information to new members clinical testing otherwise necessary to metaxalone tablets, 640 mg, from sale.
regarding their role & duties on this gain approval of a new drug application We have also independently evaluated
subcommittee. Agenda items are subject (NDA). relevant literature and data for possible
to change as priorities dictate. The 1984 amendments include what postmarketing adverse events. We have
The Director, Management Analysis is now section 505(j)(7) of the Federal reviewed the available evidence and
and Services Office, has been delegated Food, Drug, and Cosmetic Act (21 U.S.C. determined that this drug product was
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Document Created: 2018-07-27 04:05:34
Document Modified: 2018-07-27 04:05:34
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| FR Citation | 83 FR 35646 |
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