Recommendations To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components; Draft Guidance for Industry; Availability
| Published date | 31 January 2020 |
| Citation | 85 FR 5668 |
| Record Number | 2020-01815 |
| Section | Notices |
| Court | Food And Drug Administration |
5668
Federal Register / Vol. 85, No. 21 / Friday, January 31, 2020 / Notices
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
Data Collection for CDC Fellowship
Programs (OMB Control No. 0920–1163,
Exp. 2/29/2020)—Extension—Division
of Scientific Education and Professional
Development (DSEPD), Center for
Surveillance, Epidemiology, and
Laboratory Services (CSELS), Centers for
Disease Control and Prevention (CDC).
Background and Brief Description
CDC’s mission is to protect America
from health, safety, and security threats,
both foreign and in the U.S. To ensure
a competent, sustainable, and
empowered public health workforce
prepared to meet these challenges, CDC
plays a key role in developing,
implementing, and managing a number
of fellowship programs. A fellowship is
defined as a training or work experience
lasting at least one month and
consisting of primarily experiential (i.e.,
on-the-job) learning, in which the
trainee has a designated mentor or
supervisor. CDC fellowships are
intended to develop public health
professionals, enhance the public health
workforce, and strengthen
collaborations with partners in public
health and healthcare organizations,
academia, and other stakeholders in
governmental and non-governmental
organizations. Assessing fellowship
activities is essential to ensure that the
public health workforce is equipped to
promote and protect the public’s health.
CDC requests a three-year extension of
a generic clearance to collect data about
its fellowship programs, as they relate to
public health workforce development.
Data collections will allow for ongoing,
collaborative, and actionable
communications between CDC
fellowship programs and stakeholders
(e.g., fellows, supervisors/mentors,
alumni). These collections might
include short surveys, interviews, and
focus groups. Intended use of the
resulting information is to
•inform planning, implementation,
and continuous quality improvement of
fellowship activities and services;
•improve efficiencies in the delivery
of fellowship activities and services;
and
•determine to what extent fellowship
activities and services are achieving
established goals.
Collection and use of information
about CDC fellowship activities will
help ensure effective, efficient, and
satisfying experiences among fellowship
program participants and stakeholders.
CDC estimates that annually, a given
fellowship program will conduct one
query each with one of the three
respondent groups: Fellowship
applicants or fellows; mentors,
supervisors, or employers; and alumni.
The total annualized burden hours of
2,957 was determined as depicted in the
following table.
OMB approval is requested for three
years. There are no costs to respondents
other than their time.
E
STIMATED
A
NNUALIZED
B
URDEN
H
OURS
Type of respondents Form name Number of
respondents
Number of
responses per
respondent
Average
burden per
response
(in hours)
Applicants or fellows ....................................... Fellowship Data Collection Instrument ........... 1,848 1 30/60
Mentors, supervisors, or employers ............... Fellowship Data Collection Instrument ........... 370 1 30/60
Alumni ............................................................. Fellowship Data Collection Instrument ........... 3,696 1 30/60
Jeffery M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2020–01860 Filed 1–30–20; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–D–0307]
Recommendations To Reduce the
Possible Risk of Transmission of
Creutzfeldt-Jakob Disease and Variant
Creutzfeldt Jakob Disease by Blood
and Blood Components; Draft
Guidance for Industry; Availability
AGENCY
: Food and Drug Administration,
HHS.
ACTION
: Notice of availability.
SUMMARY
: The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance entitled ‘‘Recommendations to
Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease and Variant Creutzfeldt Jakob
Disease by Blood and Blood
Components.’’ The draft guidance
provides blood establishments that
collect blood and blood components
with revised recommendations intended
to reduce the possible risk of
transmission of Creutzfeldt-Jakob
disease (CJD) and variant Creutzfeldt-
Jakob disease (vCJD) by blood and blood
components. The recommendations in
the draft guidance apply to the
collection of Whole Blood and blood
components intended for transfusion or
for use in further manufacturing,
including Source Plasma. The draft
guidance replaces the document entitled
‘‘Amendment to ‘Revised Preventive
Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease and Variant Creutzfeldt-Jakob
Disease by Blood and Blood Products,’ ’’
Draft Guidance for Industry, dated
December 2017, and when finalized,
will supersede the document entitled
‘‘Revised Preventive Measures to
Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease and Variant Creutzfeldt-Jakob
Disease by Blood and Blood Products,
Guidance for Industry,’’ dated May 2010
and updated January 2016.
DATES
: Submit either electronic or
written comments on the draft guidance
by March 31, 2020 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES
: You may submit comments
on any guidance at any time as follows:
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Electronic Submissions
Submit electronic comments in the
following way:
•Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
•If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
•Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
•For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2012–D–0307 for ‘‘Recommendations to
Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease and Variant Creutzfeldt Jakob
Disease by Blood and Blood
Components.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
•Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-2015-
09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the Office
of Communication, Outreach and
Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist the office in processing your
requests. The draft guidance may also be
obtained by mail by calling CBER at 1–
800–835–4709 or 240–402–8010. See
the
SUPPLEMENTARY INFORMATION
section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT
:
Sana F. Hussain, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993–0002, 240–
402–7911.
SUPPLEMENTARY INFORMATION
:
I. Background
FDA is announcing the availability of
a draft guidance entitled
‘‘Recommendations to Reduce the
Possible Risk of Transmission of
Creutzfeldt-Jakob Disease and Variant
Creutzfeldt Jakob Disease by Blood and
Blood Components.’’ The draft guidance
provides blood establishments that
collect blood and blood components
with revised recommendations intended
to reduce the possible risk of
transmission of CJD and vCJD by blood
and blood components. The
recommendations in the draft guidance
apply to the collection of Whole Blood
and blood components intended for
transfusion or for use in further
manufacturing, including Source
Plasma. FDA is revising or removing our
current recommendations to screen
blood donors for: (1) Geographic risk of
possible exposure to bovine spongiform
encephalopathy, including time spent
on U.S. military bases in Europe; (2)
receipt of a blood transfusion in certain
vCJD risk countries; (3) risk factors for
iatrogenic CJD (i.e., a history of taking
human cadaveric pituitary-derived
growth hormone; (4) having blood
relatives with CJD; and (5) a history of
injecting bovine insulin.
In the Federal Register of December
22, 2017 (82 FR 60747), FDA announced
the availability of the draft document
entitled ‘‘Amendment to ‘Revised
Preventive Measures to Reduce the
Possible Risk of Transmission of
Creutzfeldt-Jakob Disease and Variant
Creutzfeldt-Jakob Disease by Blood and
Blood Products’ ’’ dated December 2017
(December 2017 draft guidance). FDA
received several comments on the
December 2017 draft guidance. Based on
those comments, FDA is announcing a
revised draft guidance. The draft
guidance announced in this notice
replaces the December 2017 draft
guidance, and, when finalized, will
supersede the document entitled
‘‘Revised Preventive Measures to
Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease and Variant Creutzfeldt-Jakob
Disease by Blood and Blood Products,
Guidance for Industry,’’ dated May 2010
and updated January 2016.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on recommendations to reduce the
possible risk of transmission of CJD and
vCJD by blood and blood components.
It does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
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Federal Register / Vol. 85, No. 21 / Friday, January 31, 2020 / Notices
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
This draft guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3521). The collections
of information in 21 CFR 601.12 and
Form FDA 356h have been approved
under OMB control number 0910–0338;
the collections of information in 21 CFR
parts 610 and 630 have been approved
under OMB control numbers 0910–
0116.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/vaccines-blood-
biologics/guidance-compliance-
regulatory-information-biologics/
biologics-guidances or https://
www.regulations.gov.
Dated: January 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01815 Filed 1–30–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the CDC/HRSA Advisory
Committee on HIV, Viral Hepatitis and
STD Prevention and Treatment
AGENCY
: Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION
: Notice.
SUMMARY
: In accordance with the
Federal Advisory Committee Act, this
notice announces that the Centers for
Disease Control and Prevention (CDC)/
HRSA Advisory Committee on HIV,
Viral Hepatitis and STD Prevention and
Treatment (CHAC) has scheduled a
public meeting. Information about
CHAC can be found at https://
www.cdc.gov/maso/facm/facm
CHACHSPT.html.
DATES
: March 5, 2020, 3:00 p.m.—4:00
p.m. Eastern Time (ET).
ADDRESSES
: This meeting will be held
by webinar and will accommodate up to
100 attendees. To access the virtual
meeting, please use the information
below.
•Webinar link: https://
hrsa.connectsolutions.com/chac_
business_meeting/
•Conference call-in number:
ÆCall in: 888–790–1964.
ÆPasscode: 1251991.
FOR FURTHER INFORMATION CONTACT
:
Theresa Jumento, Public Health
Advisor, HIV/AIDS Bureau, HRSA, 5600
Fishers Lane, Rockville, Maryland
20857; 301–443–5807; or
CHACAdvisoryComm@hrsa.gov.
SUPPLEMENTARY INFORMATION
: CHAC was
established under Section 222 of the
Public Health Service (PHS) Act, [42
U.S.C. Section 217a], as amended.
The purpose of CHAC is to advise the
Secretary of HHS, the Director of CDC,
and the HRSA Administrator regarding
objectives, strategies, policies, and
priorities for HIV, viral hepatitis, and
other STDs; prevention and treatment
efforts including surveillance of HIV
infection, viral hepatitis, other STDs,
and related behaviors; epidemiologic,
behavioral, health services, and
laboratory research on HIV, viral
hepatitis, and other STDs; identification
of policy issues related to HIV/viral
hepatitis/STD professional eduction,
patient healthcare delivery, and
prevention services; agency policies
about prevention of HIV, viral hepatitis
and other STDs; treatment, healthcare
delivery, and research and training;
strategic issues influencing the ability of
CDC and HRSA to fulfill their missions
of providing prevention and treatment
services; programmatic efforts to
prevent and treat HIV, viral hepatitis,
and other STDs; and support to the
agencies in their developoment of
responses to emerging health needs
related to HIV, viral hepatitis, and other
STDs.
During the March 5, 2020, meeting,
CHAC will discuss issues related to a
CDC pilot on recency assay-based
incidence estimation and the President’s
initiative on ‘‘Ending the HIV Epidemic:
A Plan for America.’’ Agenda items are
subject to change as priorities dictate.
Due to the nature and time limitations
of the meeting, members of the public
will not have an opportunity to provide
oral comments, although written
comments may be submitted prior to the
meeting, or up to 5 business days after
the meeting, to Theresa Jumento at the
contact information listed above.
Individuals who plan to attend and
need special assistance or another
reasonable accommodation should
notify Theresa Jumento at the address
and phone number listed above at least
10 business days prior to the meeting.
Maria G. Button,
Director, Division of the Executive Secretariat.
[FR Doc. 2020–01809 Filed 1–30–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Advisory Committee on Rural
Health and Human Services
AGENCY
: Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION
: Notice.
SUMMARY
: In accordance with the
Federal Advisory Committee Act, this
notice announces that the Secretary’s
National Advisory Committee on Rural
Health and Human Services
(NACRHHS) has scheduled a public
meeting. Information about NACRHHS
and the agenda for this meeting can be
found on the NACRHHS website at
https://www.hrsa.gov/advisory-
committees/rural-health/index.html.
DATES
: March 2, 2020, 8:30 a.m.–5:15
p.m. Eastern Time (ET); March 3, 2020,
8:30 a.m.–5:15 p.m. ET; and March 4,
2020, 8:30 a.m.–11:15 a.m. ET.
ADDRESSES
: The address for the meeting
is the Center for Disease Control and
Prevention (CDC) Global
Communications Center (GCC)
Auditorium B3, 1600 Clifton Road,
Atlanta, GA 30329.
On the morning of March 3, 2020,
NACRHHS will break into
subcommittees. One subcommittee will
travel to Mercer School of Medicine,
1550 College St., Macon, GA 31207. The
other subcommittee will travel to Health
Services Center, 608 Martin Luther King
Drive, Hobson City, AL 36201. In the
afternoon, at approximately 4:00 p.m.
ET., NACRHHS will reconvene at the
CDC GCC.
FOR FURTHER INFORMATION CONTACT
:
Steven Hirsch, Administrative
Coordinator at the Federal Office of
Rural Health Policy, HRSA, 5600
Fishers Lane, 17W59D, Rockville,
Maryland 20857; 301–443–7322; or
shirsch@hrsa.gov.
SUPPLEMENTARY INFORMATION
:
NACRHHS provides advice and
recommendations to the Secretary of
HHS (Secretary) on policy, program
development, and other matters of
significance concerning both rural
health and rural human services.
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