30 Day FRN

Federal Register / Vol. 84, No. 203 / Monday, October 21, 2019 / Notices
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002; or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research,
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 that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Rick
Ensor, Center for Drug Evaluation and
Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 75, Rm. 6652, Silver Spring,
MD 20993–0002, 240–402–2733, or
Stephen Ripley, 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:

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I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Drug Master Files.’’ Once finalized,
this guidance will provide FDA’s
current thinking on DMFs, which are
submissions to FDA that may be used to
provide confidential, detailed
information about facilities, processes,
or articles used in the manufacturing,
processing, packaging, and storing of
human drug products. DMFs are
submitted solely at the discretion of
their holders and are not required by
statute or regulation. After submission,

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information in DMFs can be
incorporated by reference into
applications 1 or other DMFs submitted
to FDA.
This draft guidance, when finalized,
will revise the guidance for industry
‘‘Drug Master Files: Guidelines’’ that
published in September 1989. This
update includes a change in FDA’s
contact person for the guidance, new
procedures for DMFs referenced in
abbreviated new drug applications that
reflect commitments under the Generic
Drug User Fee Amendments of 2012
(Pub. L. No. 112–144, Title III;
reauthorized in 2017, Pub. L. 115–52),
more detailed instructions regarding the
submission of original DMFs versus
amendments, reference to the electronic
submission requirements under section
745A of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
379k–1) that apply to certain DMFs,
removal of Type I as a DMF category,
and clarification and reorganization of
material associated with Type III and
Type IV DMFs.
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 ‘‘Drug Master Files.’’ 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
This draft guidance refers to
previously approved collections of
information that 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
collection of information in 21 CFR part
314 has been approved under OMB
control number 0910–0001.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
1 This guidance focuses on DMFs under 21 CFR
314.420 that are used to support new drug
applications, abbreviated new drug applications,
and investigational new drug applications under
the FD&C Act and DMFs and other master files
under 21 CFR 601.51(a) that are used to support
biologics license applications under the Public
Health Service Act. Additionally, information
contained in DMFs can generally be referenced in
premarket submissions for devices (e.g., premarket
approvals) and animal drugs (e.g., new animal drug
applications).

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Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: October 15, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–22821 Filed 10–18–19; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[1651–0111]

Agency Information Collection
Activities: Arrival and Departure
Record (Forms I–94, I–94W) and
Electronic System for Travel and
Authorization (ESTA)
U.S. Customs and Border
Protection (CBP), Department of
Homeland Security (DHS).
ACTION: 30-Day notice and request for
comments; extension of an existing
collection of information.
AGENCY:

The Department of Homeland
Security, U.S. Customs and Border
Protection 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 of 1995 (PRA). The
information collection is published in
the Federal Register to obtain comments
from the public and affected agencies.
Comments are encouraged and must be
submitted (no later than November 20,
2019) to be assured of consideration.
ADDRESSES: Interested persons are
invited to submit written comments on
this proposed information collection to
the Office of Information and Regulatory
Affairs, Office of Management and
Budget. Comments should be addressed
to the OMB Desk Officer for Customs
and Border Protection, Department of
Homeland Security, and sent via
electronic mail to dhsdeskofficer@
omb.eop.gov.
SUMMARY:

FOR FURTHER INFORMATION CONTACT:

Requests for additional PRA information
should be directed to Seth Renkema,
Chief, Economic Impact Analysis
Branch, U.S. Customs and Border
Protection, Office of Trade, Regulations
and Rulings, 90 K Street NE, 10th Floor,
Washington, DC 20229–1177,
Telephone number 202–325–0056 or via
email [email protected]. Please
note that the contact information
provided here is solely for questions
regarding this notice. Individuals
seeking information about other CBP

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Federal Register / Vol. 84, No. 203 / Monday, October 21, 2019 / Notices

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programs should contact the CBP
National Customer Service Center at
877–227–5511, (TTY) 1–800–877–8339,
or CBP website at https://www.cbp
.gov/.
SUPPLEMENTARY INFORMATION: CBP
invites the general public and other
Federal agencies to comment on the
proposed and/or continuing information
collections pursuant to the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.). This proposed information
collection was previously published in
the Federal Register (84 FR 41727) on
August 15, 2019, allowing for a 60-day
comment period. This notice allows for
an additional 30 days for public
comments. This process is conducted in
accordance with 5 CFR 1320.8. Written
comments and suggestions from the
public and affected agencies should
address one or more of the following
four points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information will have
practical utility; (2) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
suggestions to enhance the quality,
utility, and clarity of the information to
be collected; and (4) suggestions to
minimize the burden of the collection of
information on those who are to
respond, including through the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology, e.g., permitting
electronic submission of responses. The
comments that are submitted will be
summarized and included in the request
for approval. All comments will become
a matter of public record.
Overview of This Information
Collection
Title: Arrival and Departure Record,
Nonimmigrant Visa Waiver Arrival/
Departure, Electronic System for Travel
Authorization (ESTA).
OMB Number: 1651–0111.
Form Numbers: CBP Forms I–94 and
I–94W.
Current Actions: This submission is
being made to extend the expiration
date of this information collection with
no changes to the burden hours or to the
information collected.
Type of Review: Extension (with no
change).
Affected Public: Individuals.
Abstract: Forms I–94 (Arrival/
Departure Record) and I–94W
(Nonimmigrant Visa Waiver Arrival/
Departure Record) are used to document

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a traveler’s admission into the United
States. These forms are filled out by
aliens and are used to collect
information on citizenship, residency,
passport, and contact information. The
data elements collected on these forms
enable the Department of Homeland
Security (DHS) to perform its mission
related to the screening of alien visitors
for potential risks to national security
and the determination of admissibility
to the United States. The Electronic
System for Travel Authorization (ESTA)
applies to aliens seeking to travel to the
United States under the Visa Waiver
Program (VWP) and requires that VWP
travelers provide information
electronically to CBP before embarking
on travel to the United States without a
visa. Travelers who are entering the
United States under the VWP in the air
or sea environment, and who have a
travel authorization obtained through
ESTA, are not required to complete the
paper Form I–94W. I–94 is provided for
by 8 CFR 235.1(h), ESTA is provided for
by 8 CFR 217.5.
Recent Changes
On November 27, 2017, the Secretary
of State designated DPRK, as a State
Sponsor of Terrorism, or SST. Countries
determined by the Secretary of State ‘‘to
have repeatedly provided support for
acts of international terrorism’’ are
considered to have been designated as
‘‘state sponsors of terrorism.’’
Section 217(a)(12)(A)(i) of the
Immigration and Nationality Act, 8
U.S.C. 1187(a)(12)(A)(i) bars from travel
under the Visa Waiver Program (VWP)
nationals of VWP program countries
who have ‘‘been present, at any time on
or after March 1, 2011,’’ . . . ‘‘in a
country that is designated by the
Secretary of State’’ as a SST.
To meet the requirements and intent
of the law and to keep ESTA and Form
I–94W aligned, DHS is strengthening the
security of the United States through
enhancements to the ESTA application,
and Form I–94W. Existing questions
that request information from
applicants/enrollees about countries to
which they have traveled on or after
March 1, 2011; countries of which they
are citizens/nationals; and countries for
which they hold passports are being
revised to include, the DPRK.
Under the Emergency Clearance
request process DHS has recently added
DPRK to the following question to ESTA
and Form I–94W (no change has been
made to Form I–94): ‘‘Have you traveled
to, or been present in Iran, Iraq, Syria,
Sudan, Libya, Somalia, Yemen, or the
Democratic People’s Republic of Korea
(North Korea) on or after March 1, 2011?

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If yes, provide the country, date(s) of
travel, and reason for travel.’’
Form I–94 (Arrival and Departure
Record)
Estimated Number of Respondents:
4,387,550.
Estimated Time per Response: 8
minutes.
Estimated Burden Hours: 583,544.
Estimated Annual Cost to Public:
$26,325,300.
I–94 Website
Estimated Number of Respondents:
3,858,782.
Estimated Time per Response: 4
minutes.
Estimated Annual Burden Hours:
254,679.
Form I–94W (Nonimmigrant Visa
Waiver Arrival/Departure)
Estimated Number of Respondents:
941,291.
Estimated Time per Response: 16
minutes.
Estimated Annual Burden Hours:
251,325.
Estimated Annual Cost to the Public:
$5,647,746.
Electronic System for Travel
Authorization (ESTA)
Estimated Number of Respondents:
23,010,000.
Estimated Time per Response: 23
minutes.
Estimated Total Annual Burden
Hours: 8,812,830.
Estimated Annual Cost to the Public:
$265,020,000.
Dated: October 16, 2019.
Seth D. Renkema,
Branch Chief, Economic Impact Analysis
Branch, U.S. Customs and Border Protection.
[FR Doc. 2019–22861 Filed 10–18–19; 8:45 am]
BILLING CODE 9111–14–P

DEPARTMENT OF HOMELAND
SECURITY
U.S. Customs and Border Protection
[1651–0008]

Agency Information Collection
Activities: Application for Identification
Card
U.S. Customs and Border
Protection (CBP), Department of
Homeland Security.
ACTION: 30-Day notice and request for
comments; extension of an existing
collection of information.
AGENCY:

The Department of Homeland
Security, U.S. Customs and Border

SUMMARY:

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