Agency Information Collection Activities; Proposed Collection; Comment Request; User Account Management Function for the Import Trade Auxiliary Communication System, 58942-58944 [2016-20472]
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58942
Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Notices
(74 FR 47804). After consideration of
comments received in response to the
draft guidance, the guidance was
restructured to describe general
approaches to microbiology data
collection in the body of the guidance
and to provide more specific
recommendations in appendixes (e.g.,
the format for microbiology data
presentation and an example for
sections of labeling that pertain to
microbiology).
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on the development,
analysis, and presentation of
microbiology data for systemic
antibacterial drugs. 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.
mstockstill on DSK3G9T082PROD with NOTICES
II. The Paperwork Reduction Act of
1995
This 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).
1. This guidance provides
recommendations on the type of
information to include in submissions
of the clinical microbiology section of
investigational new drug applications
(INDs) and new drug applications
(NDAs) for systemic antibacterial drugs.
The microbiology section of an NDA is
required under 21 CFR 314.50(d)(4) and
this information collection is approved
under OMB control number 0910–0001.
For INDs, this information is required
under 21 CFR 312.23(a) and approved
under OMB control number 0910–0014.
2. This guidance also recommends the
types of data that should be submitted
in a labeling supplement to update the
microbiology information in approved
labeling if an application holder chooses
to update this information without
relying on a standard recognized by
FDA. The submission of labeling
supplements is required under 21 CFR
314.70(b)(2)(v) and 201.56(a)(2) and this
information collection is approved
under OMB control numbers 0910–0001
and 0910–0572, respectively.
3. Appendix D of this guidance
describes the content of the
Microbiology subsection of labeling.
This labeling is covered under 21 CFR
201.57(c)(13)(i) and the information
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collection is approved under OMB
control number 0910–0572.
4. This guidance also references the
guidance for industry entitled
‘‘Updating Labeling for Susceptibility
Test Information in Systemic
Antibacterial Drug Products and
Antimicrobial Susceptibility Testing
Devices’’ for updating labeling
information. The information collection
in this guidance has been approved
under OMB control number 0910–0638.
III. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: August 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–20473 Filed 8–25–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2496]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; User Account
Management Function for the Import
Trade Auxiliary Communication
System
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the collection of information required to
implement user account management
function in FDA’s Import Trade
Auxiliary Communication System
(ITACS). Secure user accounts will
allow import trade users to receive
Notices of FDA Action and requests for
specific information via email or via
download within ITACS.
DATES: Submit either electronic or
written comments on the collection of
information by October 25, 2016.
SUMMARY:
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ADDRESSES:
You may submit comments
as follows:
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): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, 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–
2016–N–2496 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; User
Account Management Function for the
Import Trade Auxiliary Communication
System.’’ 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
Division of Dockets Management
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
E:\FR\FM\26AUN1.SGM
26AUN1
Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Notices
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 Division of Dockets
Management. 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.fda.gov/
regulatoryinformation/dockets/
default.htm.
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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A63, 11601 Landsdown
FOR FURTHER INFORMATION CONTACT:
St., North Bethesda, 20852, PRAStaff@
fda.hhs.gov.
Under the
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.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
SUPPLEMENTARY INFORMATION:
58943
Account Management Function for the
Import Trade Auxiliary Communication
System—OMB Control Number 0910–
NEW
ITACS currently provides the import
trade community with four functions:
The ability to check the status of FDAregulated entries and lines, the ability to
submit entry documentation
electronically, the ability to
electronically submit the location of
goods for those lines targeted for FDA
physical examination, and the ability to
check estimated laboratory analysis
completion dates. No user login
accounts are currently necessary to
access these functions; all that is
necessary is a valid customs entry
number that has been successfully
transmitted to FDA.
FDA has developed ITACS user
account management functionality.
Implementation of this functionality
would allow members of the import
trade community to create and manage
secure user accounts in ITACS, which
would enable FDA to distribute Notices
of FDA Action to users electronically
via email (rather than regular mail),
enable users to download Notices of
FDA Action from within ITACS, and
allow users to view in ITACS the details
of specific information requests which
are currently delivered via hard copy
Notices of FDA Action. ITACS user
account management functionality
would also allow for potential future
ITACS enhancements, requested by the
import trade community, that require
user authentication.
To create a secure user account for
ITACS via the user account management
function, a person would have to enter
basic information such as the person’s
name, their employer’s name, a contact
email address, an account password,
etc., into ITACS via the user account
management function interface.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
Activity
Creation of ITACS account ...................................
mstockstill on DSK3G9T082PROD with NOTICES
1 There
Number of
responses per
respondent
5,000
1
Total annual
responses
5,000
Average burden
per response
0.5 (30 minutes) ...........
are no capital costs or operating and maintenance costs associated with this collection of information.
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Total hours
2,500
58944
Federal Register / Vol. 81, No. 166 / Friday, August 26, 2016 / Notices
Dated: August 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–20472 Filed 8–25–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration, HHS.
ACTION: Notice.
AGENCY:
The Health Resources and
Services Administration (HRSA) is
publishing this notice of petitions
received under the National Vaccine
Injury Compensation Program (the
Program), as required by Section
2112(b)(2) of the Public Health Service
(PHS) Act, as amended. While the
Secretary of Health and Human Services
is named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact the Clerk, United States
Court of Federal Claims, 717 Madison
Place NW., Washington, DC 20005,
(202) 357–6400. For information on
HRSA’s role in the Program, contact the
Director, National Vaccine Injury
Compensation Program, 5600 Fishers
Lane, Room 08N146B, Rockville, MD
20857; (301) 443–6593, or visit our Web
site at: https://www.hrsa.gov/
vaccinecompensation/.
SUPPLEMENTARY INFORMATION: The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the U.S. Court of Federal Claims and to
serve a copy of the petition on the
Secretary of Health and Human
Services, who is named as the
respondent in each proceeding. The
Secretary has delegated this
responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
21:17 Aug 25, 2016
Jkt 238001
as to eligibility for, and amount of,
compensation.
A petition may be filed with respect
to injuries, disabilities, illnesses,
conditions, and deaths resulting from
vaccines described in the Vaccine Injury
Table (the Table) set forth at 42 CFR
100.3. This Table lists for each covered
childhood vaccine the conditions that
may lead to compensation and, for each
condition, the time period for
occurrence of the first symptom or
manifestation of onset or of significant
aggravation after vaccine
administration. Compensation may also
be awarded for conditions not listed in
the Table and for conditions that are
manifested outside the time periods
specified in the Table, but only if the
petitioner shows that the condition was
caused by one of the listed vaccines.
Section 2112(b)(2) of the PHS Act, 42
U.S.C. 300aa–12(b)(2), requires that
‘‘[w]ithin 30 days after the Secretary
receives service of any petition filed
under section 2111 the Secretary shall
publish notice of such petition in the
Federal Register.’’ Set forth below is a
list of petitions received by HRSA on
July 1, 2016, through July 31, 2016. This
list provides the name of petitioner, city
and state of vaccination (if unknown
then city and state of person or attorney
filing claim), and case number. In cases
where the Court has redacted the name
of a petitioner and/or the case number,
the list reflects such redaction.
Section 2112(b)(2) also provides that
the special master ‘‘shall afford all
interested persons an opportunity to
submit relevant, written information’’
relating to the following:
1. The existence of evidence ‘‘that
there is not a preponderance of the
evidence that the illness, disability,
injury, condition, or death described in
the petition is due to factors unrelated
to the administration of the vaccine
described in the petition,’’ and
2. Any allegation in a petition that the
petitioner either:
a. ‘‘[S]ustained, or had significantly
aggravated, any illness, disability,
injury, or condition not set forth in the
Vaccine Injury Table but which was
caused by’’ one of the vaccines referred
to in the Table, or
b. ‘‘[S]ustained, or had significantly
aggravated, any illness, disability,
injury, or condition set forth in the
Vaccine Injury Table the first symptom
or manifestation of the onset or
significant aggravation of which did not
occur within the time period set forth in
the Table but which was caused by a
vaccine’’ referred to in the Table.
In accordance with Section
2112(b)(2), all interested persons may
submit written information relevant to
PO 00000
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Sfmt 4703
the issues described above in the case of
the petitions listed below. Any person
choosing to do so should file an original
and three (3) copies of the information
with the Clerk of the U.S. Court of
Federal Claims at the address listed
above (under the heading ‘‘For Further
Information Contact’’), with a copy to
HRSA addressed to Director, Division of
Injury Compensation Programs,
Healthcare Systems Bureau, 5600
Fishers Lane, 08N146B, Rockville,
Maryland 20857. The Court’s caption
(Petitioner’s Name v. Secretary of Health
and Human Services) and the docket
number assigned to the petition should
be used as the caption for the written
submission. Chapter 35 of title 44,
United States Code, related to
paperwork reduction, does not apply to
information required for purposes of
carrying out the Program.
Dated: August 18, 2016.
James Macrae,
Acting Administrator.
List of Petitions Filed
1. Joel Flores, San Antonio, Texas, Court of
Federal Claims No: 16–0788V.
2. Katie Tambouris, Manchester, New
Hampshire, Court of Federal Claims No:
16–0790V.
3. Cassie Keener, Fort Worth, Texas, Court of
Federal Claims No: 16–0791V.
4. Manya Cetlin-Salter, Exeter, New
Hampshire, Court of Federal Claims No:
16–0792V.
5. Gabrielle Salomone, Philadelphia,
Pennsylvania, Court of Federal Claims
No: 16–0795V.
6. Tara Hurley, Pawtucket, Rhode Island,
Court of Federal Claims No: 16–0797V.
7. Malka Nussbaum on behalf of S. N.,
Queens, New York, Court of Federal
Claims No: 16–0799V.
8. Donna Deaton, Gibsonville, North
Carolina, Court of Federal Claims No:
16–0802V.
9. Fredric C. Thompson, Gray, Maine, Court
of Federal Claims No: 16–0803V.
10. Sharlee Funai, Wailuku, Hawaii, Court of
Federal Claims No: 16–0807V.
11. Dolores Soltero Arias, Auburn,
Washington, Court of Federal Claims No:
16–0808V.
12. Luisa Gomes, Dorchester, Massachusetts,
Court of Federal Claims No: 16–0809V.
13. Linda Saucedo, Indialantic, Florida,
Court of Federal Claims No: 16–0810V.
14. Tasha Loyd on behalf of C. L., Tampa,
Florida, Court of Federal Claims No: 16–
0811V.
15. Rebekah R. Codde on behalf of I. R. H.,
Sacramento, California, Court of Federal
Claims No: 16–0812V.
16. Maureen Revaitis and Chris Revaitis on
behalf of J. R. Marlton, New Jersey, Court
of Federal Claims No: 16–0813V.
17. Mary Butler, San Mateo, California, Court
of Federal Claims No: 16–0814V.
18. David Palmieri, Galloway, New Jersey,
Court of Federal Claims No: 16–0818V.
19. Connor Toes, Phoenix, Arizona, Court of
E:\FR\FM\26AUN1.SGM
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]]>Agencies
[Federal Register Volume 81, Number 166 (Friday, August 26, 2016)]
[Notices]
[Pages 58942-58944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-20472]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2496]
Agency Information Collection Activities; Proposed Collection;
Comment Request; User Account Management Function for the Import Trade
Auxiliary Communication System
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
and to allow 60 days for public comment in response to the notice. This
notice solicits comments on the collection of information required to
implement user account management function in FDA's Import Trade
Auxiliary Communication System (ITACS). Secure user accounts will allow
import trade users to receive Notices of FDA Action and requests for
specific information via email or via download within ITACS.
DATES: Submit either electronic or written comments on the collection
of information by October 25, 2016.
ADDRESSES: You may submit comments as follows:
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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2016-N-2496 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; User Account Management Function
for the Import Trade Auxiliary Communication System.'' 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 Division of Dockets Management 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
[[Page 58943]]
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 Division of Dockets
Management. 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.fda.gov/regulatoryinformation/dockets/default.htm.
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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A63, 11601
Landsdown St., North Bethesda, 20852, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the 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.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Account Management Function for the Import Trade Auxiliary
Communication System--OMB Control Number 0910-NEW
ITACS currently provides the import trade community with four
functions: The ability to check the status of FDA-regulated entries and
lines, the ability to submit entry documentation electronically, the
ability to electronically submit the location of goods for those lines
targeted for FDA physical examination, and the ability to check
estimated laboratory analysis completion dates. No user login accounts
are currently necessary to access these functions; all that is
necessary is a valid customs entry number that has been successfully
transmitted to FDA.
FDA has developed ITACS user account management functionality.
Implementation of this functionality would allow members of the import
trade community to create and manage secure user accounts in ITACS,
which would enable FDA to distribute Notices of FDA Action to users
electronically via email (rather than regular mail), enable users to
download Notices of FDA Action from within ITACS, and allow users to
view in ITACS the details of specific information requests which are
currently delivered via hard copy Notices of FDA Action. ITACS user
account management functionality would also allow for potential future
ITACS enhancements, requested by the import trade community, that
require user authentication.
To create a secure user account for ITACS via the user account
management function, a person would have to enter basic information
such as the person's name, their employer's name, a contact email
address, an account password, etc., into ITACS via the user account
management function interface.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
Number of
Activity Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
----------------------------------------------------------------------------------------------------------------
Creation of ITACS account..... 5,000 1 5,000 0.5 (30 minutes) 2,500
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
[[Page 58944]]
Dated: August 22, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-20472 Filed 8-25-16; 8:45 am]
BILLING CODE 4164-01-P
