82 FR 18650 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention

Federal Register Volume 82, Issue 75 (April 20, 2017)

Page Range		18650-18652
FR Document		2017-07963

The Centers for Disease Control and Prevention (CDC), as part of its continuing efforts to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies to take this opportunity to comment on proposed, as required by the Paperwork Reduction Act of 1995. This notice invites comment on a proposed information collection plan titled ``Developmental Projects to Improve the National Health and Nutrition Examination Survey and Related Programs Generic.'' This generic clearance request covers projects that will help evaluate and improve upon issues such as survey design and operations, as well as examine the feasibility and challenges that may arise with developing future content for the National Health and Nutrition Examination Survey (NHANES) (OMB# 0920-0950, expires December 31, 2019) or similar studies.

Federal Register, Volume 82 Issue 75 (Thursday, April 20, 2017)

[Federal Register Volume 82, Number 75 (Thursday, April 20, 2017)]
[Notices]
[Pages 18650-18652]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-07963]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention

[60Day-17-17ABE; Docket No. CDC-2017-0034]


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 efforts to reduce public burden and maximize the 
utility of government information, invites the general public and other 
Federal agencies to take this opportunity to comment on proposed, as 
required by the Paperwork Reduction Act of 1995. This notice invites 
comment on a proposed information collection plan titled 
``Developmental Projects to Improve the National Health and Nutrition 
Examination Survey and Related Programs Generic.'' This generic 
clearance request covers projects that will help evaluate and improve 
upon issues such as survey design and operations, as well as examine 
the feasibility and challenges that may arise with developing future 
content for the National Health and Nutrition Examination Survey 
(NHANES) (OMB# 0920-0950, expires December 31, 2019) or similar 
studies.

DATES: Written comments must be received on or before June 19, 2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0034 by any of the following methods:
     Federal eRulemaking Portal: Regulations.gov. Follow the 
instructions for submitting comments.
     Mail: Leroy A. Richardson, 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. All relevant comments received will be posted 
without change to Regulations.gov, including any personal information 
provided. For access to the docket to read background documents or 
comments received, go to Regulations.gov.
    Please note: All public comment should be submitted 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 the Information Collection Review Office, 
Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS-
D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected].

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 OMB for approval. To 
comply with this requirement, we are publishing this notice of a 
proposed data collection as described below.
    Comments are invited on: (a) Whether the proposed collection of 
information is necessary for the proper performance of the functions of 
the agency, including whether the information shall have practical 
utility; (b) the accuracy of the agency's estimate of the burden of the 
proposed collection of information; (c) ways to enhance the quality, 
utility, and clarity of the information to be collected; (d) ways to 
minimize the burden of the collection of information on respondents, 
including through the use of automated collection techniques or other 
forms of information technology; and (e) estimates of capital or start-
up costs and costs of operation, maintenance, and purchase of services 
to provide information. Burden means the total time, effort, or 
financial resources expended by persons to generate, maintain, retain, 
disclose or provide information to or for a Federal agency. This 
includes the time needed to review instructions; to develop, acquire, 
install and utilize technology and systems for the purpose of 
collecting, validating and verifying information, processing and 
maintaining information, and disclosing and providing information; to 
train personnel and to be able to respond to

[[Page 18651]]

a collection of information, to search data sources, to complete and 
review the collection of information; and to transmit or otherwise 
disclose the information.

Proposed Project

    Developmental Projects to Improve the National Health and Nutrition 
Examination Survey and Related Programs Generic--New--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 collect statistics on the 
extent and nature of illness and disability; environmental, social and 
other health hazards; and determinants of health of the population of 
the United States. The Division of Health and Nutrition Examination 
Surveys (DHNES) has conducted national surveys and related projects 
periodically between 1970 and 1994, and continuously since 1999.
    The mission of DHNES programs is to produce descriptive statistics 
which measure the health and nutrition status of the general 
population. The continuous operation of DHNES programs presents unique 
challenges in testing new survey content and activities, such as 
outreach or participant screening etc.
    This generic request covers developmental projects to help evaluate 
and enhance DHNES existing and proposed data collection activities to 
increase research capacity and improve data quality. The information 
collected through this Generic Information Collection Request will not 
be used to make generalizable statements about the population of 
interest or to inform public policy; however, methodological findings 
from these projects may be reported.
    The purpose and use of projects under this NHANES generic clearance 
would include developmental projects necessary for activities such as 
testing new procedures, equipment, and approaches that are going to be 
folded into NHANES; designing and testing examination components or 
survey questions; creating new studies including biomonitoring and 
clinical measures; creating new cohorts, including a pregnancy and/or a 
birth--24 month cohort; testing of the cognitive and interpretive 
aspects of survey methodology; feasibility testing of proposed new 
components or modifications to existing components; testing of human-
computer interfaces/usability; assessing the acceptability of proposed 
NHANES components among likely participants; testing alternative 
approaches to existing NHANES procedures, including activities related 
to improving nonresponse; testing the use of or variations/adjustments 
in incentives; testing content of Web based surveys; testing the 
feasibility of obtaining bodily fluid specimens (blood, urine, semen, 
saliva, breastmilk) and tissue sample (swabs); testing digital imaging 
technology and related procedures (e.g., retinal scan, liver 
ultrasound, Dual-energy X-ray absorptiometry (DEXA), prescription and 
over-the-counter dietary supplements bottles); testing the feasibility 
of and procedure/processes for accessing participant's medical records 
from healthcare settings (e.g., hospitals and physician offices); 
testing the feasibility and protocols for home examination 
measurements; testing survey materials and procedures to improve 
response rates, including changes to advance materials and protocols, 
changes to the incentive structure, introduction of new and timely 
outreach and awareness procedures including the use of social media; 
conducting crossover studies; creating and testing digital survey 
materials; conducting customer satisfaction assessments.
    The types of participants covered by the NHANES generic may include 
current or past NHANES participants; family or household members of 
NHANES participants; individuals eligible to be participants in NHANES, 
but who did not screen into the actual survey; convenience samples; 
volunteers; subject matter experts or consultants such as survey 
methodologist, academic researchers, clinicians or other health care 
providers; NHANES data or Web site users; members of the general public 
or individuals abroad who would be part of a collaborative development 
project or projects between NCHS and related public health agencies in 
the U.S. and/or abroad.
    The type of participant involved in a given developmental project 
would be determined by the nature of the project. The details of each 
project will be included in the specific information collection 
requests under this generic plan.
    There is no cost to respondents other than their time. A three year 
clearance is requested.

                                                            Estimated Annualized Burden Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                              Average
                                                                                             Number of       Number of      burden per     Total burden
              Type of  respondent                               Form name                   respondents    responses per   response (in        hours
                                                                                                            respondent        hours)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Individuals, Households, Volunteers, and NHANES  Developmental Projects, Special Study,            5,500               1               3          16,500
 participants.                                    Focus Group documents.
Subject Matter Experts.........................  Focus Group/ Developmental Project                   15               1               1              15
                                                  Documents.
NHANES Web and Data users......................  Customer Satisfaction/ Usability                  1,100               2            5/60             183
                                                  Documents.
                                                                                         ---------------------------------------------------------------
    Total......................................  .......................................  ..............  ..............  ..............          16,698
--------------------------------------------------------------------------------------------------------------------------------------------------------



[[Page 18652]]

Leroy A. Richardson,
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. 2017-07963 Filed 4-19-17; 8:45 am]
 BILLING CODE 4163-18-P

18652 Federal Register / Vol. 82, No. 75 / Thursday, April 20, 2017 / Notices

Leroy A. Richardson, Current Good Manufacturing Practice corrective action was effective. In
Chief, Information Collection Review Office, in Manufacturing, Packaging, Labeling, addition, by establishing recordkeeping
Office of Scientific Integrity, Office of the or Holding Operations for Dietary requirements, FDA can ensure that
Associate Director for Science, Office of the Supplements—21 CFR Part 111; OMB industry follows CGMP during
Director, Centers for Disease Control and Control Number 0910–0606—Extension manufacturing, packaging, labeling, or
Prevention. holding operations. The regulations in
[FR Doc. 2017–07963 Filed 4–19–17; 8:45 am]
On October 25, 1994, the Dietary
Supplement Health and Education Act part 111 establish the minimum
BILLING CODE 4163–18–P
(DSHEA) (Pub. L. 103–417) was signed manufacturing practices necessary to
into law. DSHEA, among other things, ensure that dietary supplements are
amended the Federal Food, Drug, and manufactured, packaged, labeled, or
DEPARTMENT OF HEALTH AND held in a manner that will ensure the
HUMAN SERVICES Cosmetic Act (the FD&C Act) by adding
section 402(g) of the FD&C Act (21 quality of the dietary supplements
U.S.C. 342(g)). Section 402(g)(2) of the during manufacturing, packaging,
Food and Drug Administration labeling or holding operations.
FD&C Act provides, in part, that the
The recordkeeping requirements of
[Docket No. FDA–2013–N–1619] Secretary of Health and Human Services
the regulations include establishing
may, by regulation, prescribe good
written procedures and maintaining
Agency Information Collection manufacturing practices for dietary
records pertaining to: (1) Personnel; (2)
Activities; Submission for Office of supplements. Section 402(g) of the
sanitation; (3) calibration of instruments
Management and Budget Review; FD&C Act also stipulates that such
and controls; (4) calibration, inspection,
Comment Request; Current Good regulations will be modeled after or checks of automated, mechanical, or
Manufacturing Practice in current good manufacturing practice electronic equipment; (5) maintaining,
Manufacturing, Packaging, Labeling, or (CGMP) regulations for food and may cleaning, and sanitizing equipment and
Holding Operations for Dietary not impose standards for which there utensils and other contact surfaces; (6)
Supplements are no current, and generally available, water used that may become a
analytical methodology. Section component of the dietary supplement;
AGENCY: Food and Drug Administration, 402(g)(1) of the FD&C Act states that a (7) production and process controls; (8)
HHS. dietary supplement is adulterated if ‘‘it quality control; (9) components,
has been prepared, packed, or held packaging, labels and product received
ACTION: Notice.
under conditions that do not meet for packaging and labeling; (10) master
SUMMARY: The Food and Drug current good manufacturing practice manufacturing and batch production;
Administration (FDA) is announcing regulations.’’ Under section 701(a) of the (11) laboratory operations; (12)
that a proposed collection of FD&C Act (21 U.S.C. 371(a)), FDA may manufacturing operations; (13)
information has been submitted to the issue regulations necessary for the packaging and labeling operations; (14)
Office of Management and Budget efficient enforcement of the FD&C Act. holding and distributing operations; (15)
(OMB) for review and clearance under In the Federal Register of June 25, 2007 returned dietary supplements; and (16)
the Paperwork Reduction Act of 1995 (72 FR 34752), (the June 25, 2007, final product complaints.
(PRA). rule), FDA published a final rule that Description of Respondents:
established, in part 111 (21 CFR part Manufacturers, dietary supplement
DATES: Fax written comments on the 111), the minimum CGMP necessary for manufacturers, packagers and
collection of information by May 22, activities related to manufacturing, repackagers, labelers and re-labelers,
2017. packaging, labeling, or holding dietary holders, distributors, warehousers,
supplements to ensure the quality of the exporters, importers, large businesses,
ADDRESSES: To ensure that comments on dietary supplement. and small businesses engaged in the
the information collection are received, Records are an indispensable dietary supplement industry.
OMB recommends that written component of CGMP. The records The recordkeeping requirements of
comments be faxed to the Office of required by FDA’s regulations in part the regulations in part 111 are set forth
Information and Regulatory Affairs, 111 provide the foundation for the in each subpart. In table 1, we list the
OMB, Attn: FDA Desk Officer, FAX: planning, control, and improvement annual burdens associated with
202–395–7285, or emailed to oira_ processes that constitute a quality recordkeeping, as described in the June
submission@omb.eop.gov. All control system. Implementation of these 25, 2007, final rule. For some provisions
comments should be identified with the processes in a manufacturing operation listed in table 1, we did not estimate the
OMB control number 0910–0606. Also serves as the backbone to CGMP. The number of records per recordkeeper
include the FDA docket number found records show what is to be because recordkeeping occasions consist
in brackets in the heading of this manufactured; what was, in fact, of frequent brief entries of dates,
document. manufactured; and whether the controls temperatures, monitoring results, or
FOR FURTHER INFORMATION CONTACT:
that the manufacturer put in place to documentation that specific actions
JonnaLynn Capezzuto, Office of ensure the identity, purity, strength, and were taken. Information might be
Operations, Food and Drug composition and limits on contaminants recorded a few times a day, week, or
Administration, Three White Flint and to prevent adulteration were month. When the records burden
effective. Further, records will show involves frequent brief entries, we
asabaliauskas on DSK3SPTVN1PROD with NOTICES

North, 10A63, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796– whether and what deviations from entered 1 as the default for the number
3794. control processes occurred, facilitate of records per recordkeeper. For
evaluation and corrective action example, many of the records listed
SUPPLEMENTARY INFORMATION: In concerning these deviations (including, under § 111.35 in table 1, such as
compliance with 44 U.S.C. 3507, FDA where necessary, whether associated § 111.35(b)(2) (documentation, in
has submitted the following proposed batches of product should be recalled individual equipment logs, of the date
collection of information to OMB for from the marketplace), and enable a of the use, maintenance, cleaning, and
review and clearance. manufacturer to assure that the sanitizing of equipment), involve many

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Document Created: 2017-04-20 01:42:24
Document Modified: 2017-04-20 01:42:24

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
Action		Notice with comment period.
Dates		Written comments must be received on or before June 19, 2017.
Contact		To request more information on the proposed project or to obtain a copy of the information collection plan and instruments, contact the Information Collection Review Office, Centers for Disease Control and Prevention, 1600 Clifton Road NE., MS- D74, Atlanta, Georgia 30329; phone: 404-639-7570; Email: [email protected]
FR Citation		82 FR 18650

82 FR 18650 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Disease Control and Prevention

Federal Register Volume 82, Issue 75 (April 20, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention