60-Day FRN

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Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices
individuals who had contact with Ebola
patients.
Transmission of Ebola virus from
human to human occurs by direct
contact with body fluids (such as blood,
urine, stool, saliva, semen, vaginal
fluids, or vomit) of symptomatic
infected individuals. Therefore, blood
and blood products from symptomatic
individuals, if they were to donate,
would have the potential of transmitting
Ebola virus to recipients.
Current regulations 21 CFR 640.3(b)
and 21 CFR 640.63(b)(3) require that a
donor be in good health with a normal
temperature at the time of donation.
Standard procedures that are in place to
assure that the donor feels healthy at the
time of donation serve as an effective
safeguard against collecting blood or
blood components from a donor who
seeks to donate after the onset of clinical
symptoms. FDA is providing guidance
to reduce the risks of collecting blood
and blood components from potentially
Ebola virus-infected persons during the
asymptomatic incubation period before
the onset of clinical symptoms, as well
as from individuals with a history of
Ebola virus infection or disease.
The draft guidance permits blood
establishments to update their donor
educational materials to instruct donors
with a history of Ebola virus infection
or disease to not donate blood or blood
components. In the event that one or
more countries is designated as having
widespread transmission of Ebola virus,
the draft guidance includes
recommendations to blood
establishments to update their donor
history questionnaire (DHQ), including
the full-length and abbreviated DHQ
and accompanying materials, to assess
prospective donors for risk of Ebola
virus infection or disease. The draft
guidance also includes
recommendations to blood
establishments to defer indefinitely a
blood donor with a history of Ebola
virus infection or disease, until more
data regarding the persistence of Ebola
virus in survivors becomes available.
For a donor who in the past 8 weeks has
been a resident of or has travelled to a
country with widespread transmission
of Ebola virus disease, FDA
recommends that establishments defer
the donor for 8 weeks from the time of
the donor’s departure from that country.
For a donor who has had close contact
with a person confirmed or under
investigation for Ebola virus infection or
disease in whom diagnosis is pending,
FDA recommends that establishments
defer a donor for 8 weeks after the last
close contact that could have resulted in
direct contact with body fluids, or 8
weeks after the last sexual contact with

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a person known to have recovered from
Ebola virus disease. In addition, FDA
recommends that establishments defer
for a period of 8 weeks after exposure
a donor who has been notified by a
Federal, State, or local public health
authority that he or she may have been
exposed to a person with Ebola virus
disease.
The draft guidance includes FDA
recommendations on retrieval and
quarantine of blood and blood
components from a donor later
determined to have Ebola virus
infection or disease or risk factors for
Ebola virus infection or disease, for
notification of consignees, and for
reporting a biological product deviation
to FDA. The draft guidance also
addresses convalescent plasma intended
for transfusion.
The 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 for Assessment
of Blood Donor Suitability, Donor
Deferral and Blood Product
Management in Response to Ebola
Virus; Draft Guidance for Industry.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
The 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. 3501–3520). The collections
of information in 21 CFR 601.12 have
been approved under OMB control
number 0910–0338; the collections of
information in 21 CFR 606.160(b)(1)(i),
640.3(a) and 640.63(b)(3) have been
approved under OMB control number
0910–0116; the collection of
information in 21 CFR 606.171 has been
approved under OMB control number
0910–0458.
III. Electronic Access
Persons with access to the Internet
may obtain the draft guidance at either
http://www.fda.gov/
BiologicsBloodVaccines/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or http://
www.regulations.gov.

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Dated: November 27, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–30589 Filed 12–2–15; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[1651–0017]

Agency Information Collection
Activities: Protest
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: 60-Day Notice and request for
comments; extension of an existing
collection of information.
AGENCY:

U.S. Customs and Border
Protection (CBP) of the Department of
Homeland Security will be submitting
the following information collection
request to the Office of Management and
Budget (OMB) for review and approval
in accordance with the Paperwork
Reduction Act: Protest. CBP is
proposing that this information
collection be extended with no change
to the burden hours or to the
information collected. This document is
published to obtain comments from the
public and affected agencies.
DATES: Written comments should be
received on or before February 1, 2016
to be assured of consideration.
ADDRESSES: Written comments may be
mailed to U.S. Customs and Border
Protection, Attn: Tracey Denning,
Regulations and Rulings, Office of
International Trade, 90 K Street NE.,
10th Floor, Washington, DC 20229–
1177.
SUMMARY:

FOR FURTHER INFORMATION CONTACT:

Requests for additional information
should be directed to Tracey Denning,
U.S. Customs and Border Protection,
Regulations and Rulings, Office of
International Trade, 90 K Street NE.,
10th Floor, Washington, DC 20229–
1177, at 202–325–0265.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and other
Federal agencies to comment on
proposed and/or continuing information
collections pursuant to the Paperwork
Reduction Act of 1995 (Pub. L. 104–13).
The comments should address: (a)
Whether the 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

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Lhorne on DSK5TPTVN1PROD with NOTICES

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Federal Register / Vol. 80, No. 232 / Thursday, December 3, 2015 / Notices

agency’s estimates of the burden of the
collection of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; (d)
ways to minimize the burden including
the use of automated collection
techniques or the use of other forms of
information technology; and (e) the
annual cost burden to respondents or
record keepers from the collection of
information (total capital/startup costs
and operations and maintenance costs).
The comments that are submitted will
be summarized and included in the CBP
request for OMB approval. All
comments will become a matter of
public record. In this document, CBP is
soliciting comments concerning the
following information collection:
Title: Protest.
OMB Number: 1651–0017.
Form Number: Form 19.
Abstract: CBP Form 19, Protest, is
filed to seek the review of a CBP officer.
This review may be conducted by a CBP
officer who participated directly in the
underlying decision. This form is also
used to request ‘‘Further Review’’ which
means a request for review of the protest
to be performed by a CBP officer who
did not participate directly in the
protested decision, or by the
Commissioner, or his designee as
provided in the CBP Regulations.
The matters that may be protested
include: The appraised value of
merchandise; the classification and rate
and amount of duties chargeable; all
charges within the jurisdiction of the
U.S. Department of Homeland Security;
exclusion of merchandise from entry or
delivery, or demand for redelivery; the
liquidation or reliquidation of an entry;
and the refusal to pay a claim for
drawback.
The parties who may file a protest or
application for further review include:
the importer or consignee shown on the
entry papers, or their sureties; any
person paying any charge or exaction;
any person seeking entry or delivery, or
upon whom a demand for redelivery has
been made; any person filing a claim for
drawback; or any authorized agent of
any of the persons described above.
CBP Form 19 collects information
such as the name and address of the
protesting party, information about the
entry being protested, detailed reasons
for the protest, justification for applying
for further review.
The information collected on CBP
Form 19 is authorized by Sections 514
and 514(a) of the Tariff Act of 1930 and
provided for by 19 CFR part 174. This
form is accessible at http://
www.cbp.gov/sites/default/files/
documents/CBP_Form_19.pdf.

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Current Action: CBP proposes to
extend the expiration date of this
information collection with no change
to the burden hours or to the
information collected.
Type of Review: Extension (with no
change).
Affected Public: Businesses.
Estimated Number of Respondents:
3,750.
Estimated Number of Total Annual
Responses: 45,000.
Estimated Time per Response: 1 hour.
Estimated Total Annual Burden
Hours: 45,000.
Dated: November 30, 2015.
Tracey Denning,
Agency Clearance Officer, U.S. Customs and
Border Protection.
[FR Doc. 2015–30614 Filed 12–2–15; 8:45 am]
BILLING CODE 9111–14–P

DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[1651–0052]

Agency Information Collection
Activities: User Fees
U.S. Customs and Border
Protection, Department of Homeland
Security.
ACTION: 60-Day Notice and request for
comments; extension of an existing
collection of information.
AGENCY:

U.S. Customs and Border
Protection (CBP) of the Department of
Homeland Security will be submitting
the following information collection
request to the Office of Management and
Budget (OMB) for review and approval
in accordance with the Paperwork
Reduction Act: User Fees. CBP is
proposing that this information
collection be extended with no change
to the burden hours or to the
information collected. This document is
published to obtain comments from the
public and affected agencies.
DATES: Written comments should be
received on or before February 1, 2016
to be assured of consideration.
ADDRESSES: Written comments may be
mailed to U.S. Customs and Border
Protection, Attn: Tracey Denning,
Regulations and Rulings, Office of
International Trade, 90 K Street NE.,
10th Floor, Washington, DC 20229–
1177.
SUMMARY:

FOR FURTHER INFORMATION CONTACT:

Requests for additional information
should be directed to Tracey Denning,
U.S. Customs and Border Protection,
Regulations and Rulings, Office of

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International Trade, 90 K Street NE.,
10th Floor, Washington, DC 20229–
1177, at 202–325–0265.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and other
Federal agencies to comment on
proposed and/or continuing information
collections pursuant to the Paperwork
Reduction Act of 1995 (Pub. L. 104–13).
The comments should address: (a)
Whether the 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 estimates of the burden of the
collection of information; (c) ways to
enhance the quality, utility, and clarity
of the information to be collected; (d)
ways to minimize the burden including
the use of automated collection
techniques or the use of other forms of
information technology; and (e) the
annual cost burden to respondents or
record keepers from the collection of
information (total capital/startup costs
and operations and maintenance costs).
The comments that are submitted will
be summarized and included in the CBP
request for OMB approval. All
comments will become a matter of
public record. In this document, CBP is
soliciting comments concerning the
following information collection:
Title: User Fees.
OMB Number: 1651–0052.
Form Number: CBP Forms 339A,
339C and 339V.
Abstract: The Consolidated Omnibus
Budget Reconciliation Act of 1985
(COBRA—Pub. L. 99–272; 19 U.S.C.
58c) authorizes the collection of user
fees by Customs and Border Protection
(CBP). The collection of these fees
requires submission of information from
the party remitting the fees to CBP. This
information is submitted on three forms
including the CBP Form 339A for
aircraft at: http://www.cbp.gov/sites/
default/files/documents/
CBP%20Form%20339A.pdf, CBP Form
339C for commercial vehicles at:
http://www.cbp.gov/sites/default/files/
documents/CBP%20Form%20339C.pdf,
and CBP Form 339V for vessels at:
http://www.cbp.gov/sites/default/files/
documents/CBP%20Form%20339V.pdf.
The information on these forms may
also be filed electronically at: https://
dtops.cbp.dhs.gov/. This collection of
information is provided for by 19 CFR
24.22.
In addition, CBP requires express
consignment courier facilities (ECCFs)
to file lists of couriers using the facility
in accordance with 19 CFR 128.11. In
cases of overpayments, carriers using
the courier facilities may send a request

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