82_FR_14785 82 FR 14731 - Proposed Data Collection Submitted for Public Comment and Recommendations

82 FR 14731 - Proposed Data Collection Submitted for Public Comment and Recommendations

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Federal Register Volume 82, Issue 54 (March 22, 2017)

Page Range14731-14732
FR Document2017-05699

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 and/or continuing information collections, as required by the Paperwork Reduction Act of 1995. This notice invites comment on the donor registration form in support of the project titled ``Acquisition of Freshly Drawn Whole Blood/Blood Products for Reference Diagnostic and Research Use.''

Federal Register, Volume 82 Issue 54 (Wednesday, March 22, 2017)
[Federal Register Volume 82, Number 54 (Wednesday, March 22, 2017)]
[Notices]
[Pages 14731-14732]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-05699]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

[60-Day-17-17XR; Docket No. CDC-2017-0027]


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 and/or 
continuing information collections, as required by the Paperwork 
Reduction Act of 1995. This notice invites comment on the donor 
registration form in support of the project titled ``Acquisition of 
Freshly Drawn Whole Blood/Blood Products for Reference Diagnostic and 
Research Use.''

DATES: Written comments must be received on or before May 22, 2017.

ADDRESSES: You may submit comments, identified by Docket No. CDC-2017-
0027 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 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

    Acquisition of Freshly-Drawn Whole Blood/Blood Products for 
Reference Diagnostic and Research Use--Existing Information Collection 
in Use Without an OMB Control Number--National Center for Emerging and 
Zoonotic Infectious Diseases (NCEZID), Centers for Disease Control and 
Prevention (CDC).

Background and Brief Description

    The CDC seeks a three-year OMB approval to collect information in 
support of fresh blood/blood products for laboratory programs.
    The CDC regularly requires freshly drawn whole blood, serum, 
plasma, mononuclear white cell and platelet concentrates for research 
purposes, for reagents, and as ``normal'' control materials. To enhance 
the safety of CDC personnel handling these materials, the blood/blood 
products, or the donors thereof, must be screened for evidence of 
possible infections by specific testing. At the same time, donor 
confidentiality must be assured and adequate counseling must be 
available, in case any specimens or donors test positive for certain 
transmissible infections.
    The donor registration form referenced by this request is a brief, 
11-question form that establishes the availability of volunteer donors 
to participate in the donor program to fill this need for fresh blood/
blood products for CDC. The registration form captures donors' 
availability to donate, interest in various types of donations, smoking 
history, exercise background, alcohol consumption, measles vaccination 
history, cholesterol test history, and medications background.
    Donors required to maintain the CDC donor pool are recruited by 
contract program managers often by referral of current donors, directed 
outreach for new donors by email, occasional posting of notices in 
areas frequented by CDC personnel, or at local universities for 
possible student populations.
    All donor information is collected and protected by medical 
professionals with donor/patient confidentiality protected. Information 
from this form is only used to determine donor eligibility for blood 
product requests to be used by CDC laboratory programs. Approximately 
25 volunteer donors are enrolled annually.

[[Page 14732]]

    There is no cost to respondents other than the time to participate. 
Authorizing legislation comes from Section 301 of the Public Health 
Service Act (42 U.S.C. 241).

                                        Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                                     Number of      Avg. burden
      Type of respondents           Form name        Number of     responses per   per response    Total burden
                                                    respondents     respondent       (in hrs.)       (in hrs.)
----------------------------------------------------------------------------------------------------------------
General public................  Registration....              25               1           15/60               7
                                                                                                 ---------------
    Total.....................  ................  ..............  ..............  ..............               7
----------------------------------------------------------------------------------------------------------------


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. 2017-05699 Filed 3-21-17; 8:45 am]
 BILLING CODE 4163-18-P



                                                                                Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Notices                                             14731

                                                    including training needs and                            to Regulations.gov, including any                     maintaining information, and disclosing
                                                    information dissemination on health                     personal information provided. For                    and providing information; to train
                                                    care quality and (C) the role of the                    access to the docket to read background               personnel and to be able to respond to
                                                    Agency in light of private sector activity              documents or comments received, go to                 a collection of information, to search
                                                    and opportunities for public private                    Regulations.gov.                                      data sources, to complete and review
                                                    partnerships. The Council is composed                     Please note: All public comment should be           the collection of information; and to
                                                    of members of the public, appointed by                  submitted through the Federal eRulemaking             transmit or otherwise disclose the
                                                    the Secretary, and Federal ex-officio                   portal (Regulations.gov) or by U.S. mail to the       information.
                                                    members specified in the authorizing                    address listed above.
                                                                                                                                                                  Proposed Project
                                                    legislation. The Council did not have a                 FOR FURTHER INFORMATION CONTACT:              To
                                                    quorum for the meeting scheduled for                                                                            Acquisition of Freshly-Drawn Whole
                                                                                                            request more information on the                       Blood/Blood Products for Reference
                                                    March 24th. Therefore, AHRQ is                          proposed project or to obtain a copy of
                                                    cancelling the meeting. The next                                                                              Diagnostic and Research Use—Existing
                                                                                                            the information collection plan and                   Information Collection in Use Without
                                                    meeting of the NAC is planned for July                  instruments, contact the Information
                                                    26th.                                                                                                         an OMB Control Number—National
                                                                                                            Collection Review Office, Centers for                 Center for Emerging and Zoonotic
                                                    Sharon B. Arnold,                                       Disease Control and Prevention, 1600                  Infectious Diseases (NCEZID), Centers
                                                    Acting Director.                                        Clifton Road NE., MS–D74, Atlanta,                    for Disease Control and Prevention
                                                    [FR Doc. 2017–05588 Filed 3–21–17; 8:45 am]
                                                                                                            Georgia 30329; phone: 404–639–7570;                   (CDC).
                                                                                                            Email: omb@cdc.gov.
                                                    BILLING CODE 4160–90–P
                                                                                                            SUPPLEMENTARY INFORMATION: Under the                  Background and Brief Description
                                                                                                            Paperwork Reduction Act of 1995 (PRA)                   The CDC seeks a three-year OMB
                                                    DEPARTMENT OF HEALTH AND                                (44 U.S.C. 3501–3520), Federal agencies               approval to collect information in
                                                    HUMAN SERVICES                                          must obtain approval from the Office of               support of fresh blood/blood products
                                                                                                            Management and Budget (OMB) for each                  for laboratory programs.
                                                    [60-Day–17–17XR; Docket No. CDC–2017–                   collection of information they conduct                  The CDC regularly requires freshly
                                                    0027]
                                                                                                            or sponsor. In addition, the PRA also                 drawn whole blood, serum, plasma,
                                                    Proposed Data Collection Submitted                      requires Federal agencies to provide a                mononuclear white cell and platelet
                                                    for Public Comment and                                  60-day notice in the Federal Register                 concentrates for research purposes, for
                                                    Recommendations                                         concerning each proposed collection of                reagents, and as ‘‘normal’’ control
                                                                                                            information, including each new                       materials. To enhance the safety of CDC
                                                    AGENCY: Centers for Disease Control and                 proposed collection, each proposed                    personnel handling these materials, the
                                                    Prevention (CDC), Department of Health                  extension of existing collection of                   blood/blood products, or the donors
                                                    and Human Services (HHS).                               information, and each reinstatement of                thereof, must be screened for evidence
                                                    ACTION: Notice with comment period.                     previously approved information                       of possible infections by specific testing.
                                                                                                            collection before submitting the                      At the same time, donor confidentiality
                                                    SUMMARY:    The Centers for Disease                     collection to OMB for approval. To                    must be assured and adequate
                                                    Control and Prevention (CDC), as part of                comply with this requirement, we are                  counseling must be available, in case
                                                    its continuing efforts to reduce public                 publishing this notice of a proposed                  any specimens or donors test positive
                                                    burden and maximize the utility of                      data collection as described below.                   for certain transmissible infections.
                                                    government information, invites the                        Comments are invited on: (a) Whether                 The donor registration form
                                                    general public and other Federal                        the proposed collection of information                referenced by this request is a brief, 11-
                                                    agencies to take this opportunity to                    is necessary for the proper performance               question form that establishes the
                                                    comment on proposed and/or                              of the functions of the agency, including             availability of volunteer donors to
                                                    continuing information collections, as                  whether the information shall have                    participate in the donor program to fill
                                                    required by the Paperwork Reduction                     practical utility; (b) the accuracy of the            this need for fresh blood/blood products
                                                    Act of 1995. This notice invites                        agency’s estimate of the burden of the                for CDC. The registration form captures
                                                    comment on the donor registration form                  proposed collection of information; (c)               donors’ availability to donate, interest in
                                                    in support of the project titled                        ways to enhance the quality, utility, and             various types of donations, smoking
                                                    ‘‘Acquisition of Freshly Drawn Whole                    clarity of the information to be                      history, exercise background, alcohol
                                                    Blood/Blood Products for Reference                      collected; (d) ways to minimize the                   consumption, measles vaccination
                                                    Diagnostic and Research Use.’’                          burden of the collection of information               history, cholesterol test history, and
                                                    DATES: Written comments must be                         on respondents, including through the                 medications background.
                                                    received on or before May 22, 2017.                     use of automated collection techniques                  Donors required to maintain the CDC
                                                    ADDRESSES: You may submit comments,                     or other forms of information                         donor pool are recruited by contract
                                                    identified by Docket No. CDC–2017–                      technology; and (e) estimates of capital              program managers often by referral of
                                                    0027 by any of the following methods:                   or start-up costs and costs of operation,             current donors, directed outreach for
                                                       • Federal eRulemaking Portal:                        maintenance, and purchase of services                 new donors by email, occasional posting
                                                    Regulations.gov. Follow the instructions                to provide information. Burden means                  of notices in areas frequented by CDC
                                                    for submitting comments.                                the total time, effort, or financial                  personnel, or at local universities for
                                                       • Mail: Leroy A. Richardson,                         resources expended by persons to                      possible student populations.
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                    Information Collection Review Office,                   generate, maintain, retain, disclose or                 All donor information is collected and
                                                    Centers for Disease Control and                         provide information to or for a Federal               protected by medical professionals with
                                                    Prevention, 1600 Clifton Road NE., MS–                  agency. This includes the time needed                 donor/patient confidentiality protected.
                                                    D74, Atlanta, Georgia 30329.                            to review instructions; to develop,                   Information from this form is only used
                                                       Instructions: All submissions received               acquire, install and utilize technology               to determine donor eligibility for blood
                                                    must include the agency name and                        and systems for the purpose of                        product requests to be used by CDC
                                                    Docket Number. All relevant comments                    collecting, validating and verifying                  laboratory programs. Approximately 25
                                                    received will be posted without change                  information, processing and                           volunteer donors are enrolled annually.


                                               VerDate Sep<11>2014   18:14 Mar 21, 2017   Jkt 241001   PO 00000   Frm 00059   Fmt 4703   Sfmt 4703   E:\FR\FM\22MRN1.SGM   22MRN1


                                                    14732                                Federal Register / Vol. 82, No. 54 / Wednesday, March 22, 2017 / Notices

                                                      There is no cost to respondents other                                  the Public Health Service Act (42 U.S.C.
                                                    than the time to participate. Authorizing                                241).
                                                    legislation comes from Section 301 of

                                                                                                                            ESTIMATED ANNUALIZED BURDEN HOURS
                                                                                                                                                                                                         Number of                 Avg. burden
                                                                                                                                                                              Number of                                                                      Total burden
                                                               Type of respondents                                                Form name                                                            responses per               per response
                                                                                                                                                                             respondents                                                                       (in hrs.)
                                                                                                                                                                                                         respondent                  (in hrs.)

                                                    General public ...................................        Registration ......................................                              25                           1                    15/60                  7

                                                          Total ...........................................   ...........................................................   ........................   ........................   ........................              7



                                                    Leroy A. Richardson,                                                     3312(a)(6)(F), prior to issuing a final                                       Gastrointestinal, Endocrine, Urinary,
                                                    Chief, Information Collection Review Office,                             rule to add a health condition to the                                         Immune, Lymphatic, Muscular,
                                                    Office of Scientific Integrity, Office of the                            List, the Administrator must provide for                                      Nervous, Reproductive, Respiratory,
                                                    Associate Director for Science, Office of the                            an independent peer review of the                                             Skeletal) Publication list
                                                    Director, Centers for Disease Control and                                scientific and technical evidence that                                           • Other materials to support the
                                                    Prevention.                                                              would be the basis for issuing such final                                     nominee’s ability to perform scientific
                                                    [FR Doc. 2017–05699 Filed 3–21–17; 8:45 am]                              rule.                                                                         peer review
                                                    BILLING CODE 4163–18–P                                                                                                                                    • For third-party nominations,
                                                                                                                             Table of Contents:
                                                                                                                                                                                                           affirmation from the nominee that they
                                                                                                                                 •   Dates:                                                                are aware of and agree to the
                                                    DEPARTMENT OF HEALTH AND                                                     •   Addresses:                                                            nomination
                                                    HUMAN SERVICES                                                               •   For Further Information Contact:                                         A Curriculum vitae that includes all
                                                                                                                                 •   Supplementary Information:                                            of the above information may
                                                    Centers for Disease Control and                                          DATES:  Nominations must be submitted                                         alternatively be submitted.
                                                    Prevention                                                               (postmarked or electronically received)
                                                                                                                                                                                                           SUPPLEMENTARY INFORMATION: The James
                                                    [Docket Number NIOSH–294]                                                by February 1, 2019.
                                                                                                                                                                                                           Zadroga 9/11 Health and Compensation
                                                                                                                             ADDRESSES: You may submit a                                                   Reauthorization Act in section
                                                    World Trade Center Health Program;                                       nomination identified by NIOSH Docket                                         3312(a)(6)(F) requires the Administrator
                                                    Request for Nominations of Scientific                                    294, by any of the following methods.                                         to provide for an independent peer
                                                    Peer Reviewers of Proposed Additions                                        • Electronic nominations, including                                        review of the scientific and technical
                                                    to the List of WTC-Related Health                                        attachments to nioshdocket@cdc.gov.                                           evidence that would be the basis for
                                                    Conditions                                                                  • Regular, Express, or Overnight Mail:
                                                                                                                                                                                                           issuing a final rule to add a health
                                                                                                                             Written nominations may be submitted
                                                    AGENCY:  National Institute for                                                                                                                        condition to the List prior to issuing the
                                                                                                                             (one original and two copies) to the
                                                    Occupational Safety and Health                                                                                                                         final rule. To assist in accomplishing
                                                                                                                             following address only: NIOSH Docket
                                                    (NIOSH) of the Centers for Disease                                                                                                                     independent peer review in a timely
                                                                                                                             294, c/o Kiana Harper, National Institute
                                                    Control and Prevention (CDC),                                                                                                                          manner, the Administrator has
                                                                                                                             for Occupational Safety and Health,
                                                    Department of Health and Human                                                                                                                         determined that he will develop a
                                                                                                                             Centers for Disease Control and
                                                    Services (HHS).                                                                                                                                        standing pool of persons with the
                                                                                                                             Prevention, Patriots Plaza 1, 95 E Street
                                                    ACTION: Request for scientific peer                                                                                                                    scientific, technical, and medical
                                                                                                                             SW., Suite 9200, Washington, DC 20201.
                                                    reviewers.                                                                                                                                             background to potentially serve in this
                                                                                                                             Telephone and facsimile submissions
                                                                                                                                                                                                           role to provide their individual input to
                                                                                                                             cannot be accepted.
                                                    SUMMARY:   The CDC is soliciting                                                                                                                       the Administrator based on the health
                                                    nominations, including self-                                             FOR FURTHER INFORMATION CONTACT: Paul
                                                                                                                                                                                                           condition in the proposed rule under
                                                    nominations, for scientific peer                                         Middendorf, Ph.D., Deputy Associate                                           consideration. The peer reviewers will
                                                    reviewers of proposed additions of                                       Director for Science, 1600 Clifton Rd.                                        not meet as a group, provide consensus
                                                    conditions to the List of World Trade                                    NE., MS: E–20, Atlanta, GA 30329;                                             advice or recommendations to the
                                                    Center (WTC)-Related Health                                              telephone (404)498–2500 (this is not a                                        Administrator, or produce a collective
                                                    Conditions (List).                                                       toll-free number); email pmiddendorf@                                         work product(s). Therefore, the
                                                      Title I of the James Zadroga 9/11                                      cdc.gov.                                                                      Administrator is requesting nominations
                                                    Health and Compensation Act of 2010,                                        Instructions: Nominations of peer
                                                                                                                                                                                                           of persons to serve as scientific peer
                                                    Public Law 111–347 (Jan. 2, 2011),                                       reviewers must be accompanied by:
                                                                                                                                                                                                           reviewers.
                                                                                                                                • Name
                                                    amended by Public Law 114–113 (Dec.                                         • Occupation                                                                  All persons who have the necessary
                                                    18, 2015), added Title XXXIII to the                                        • Employer                                                                 minimum qualifications will be
                                                    Public Health Service Act (PHS Act),                                        • Contact information including                                            included in the standing pool of
                                                    establishing the WTC Health Program                                      mailing address, email, and phone                                             potential peer reviewers. These persons
                                                    within HHS (42 U.S.C. 300mm to                                                                                                                         will be included in the standing pool of
asabaliauskas on DSK3SPTVN1PROD with NOTICES




                                                                                                                             number
                                                    300mm–61). When the Administrator                                           • Listing of scientific credentials                                        potential peer reviewers for 3 years
                                                    proposes to add a condition to the List,                                 including academic degrees and                                                unless they request in writing to be
                                                    he must publish the proposed rule in                                     specialized training                                                          removed. After 3 years persons may be
                                                    accordance with the Administrative                                          • Area of competencies (e.g., medical,                                     nominated again and will be required to
                                                    Procedure Act (5 U.S.C. 553).                                            epidemiology, exposure assessment,                                            update their information.
                                                    Additionally, as required by the James                                   industrial hygiene)                                                              The Administrator will select peer
                                                    Zadroga 9/11 Health and Compensation                                        • Area of specialty (e.g.,                                                 reviewers for any proposed rule by
                                                    Reauthorization Act in section                                           Cardiovascular, Integumentary,                                                matching the nature of the proposed


                                               VerDate Sep<11>2014        18:14 Mar 21, 2017        Jkt 241001      PO 00000         Frm 00060        Fmt 4703       Sfmt 4703       E:\FR\FM\22MRN1.SGM                22MRN1



Document Created: 2017-03-22 03:58:24
Document Modified: 2017-03-22 03:58:24
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice with comment period.
DatesWritten comments must be received on or before May 22, 2017.
ContactTo 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 Citation82 FR 14731 

2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR