Agency Information Collection Activities: Submission for OMB Review, 7463 [2014-02660]
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Federal Register / Vol. 79, No. 26 / Friday, February 7, 2014 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifiers: CMS–R–53]
Agency Information Collection
Activities: Submission for OMB Review
ACTION:
Notice; withdrawal.
The Centers for Medicare and
Medicaid Services published a
document in the Federal Register on
January 27, 2014, concerning the
submission of an information collection
request for OMB review and a request
for public comments. The document
was published in error.
SUMMARY:
Withdrawal
In the Federal Register of January 27,
2014, in FR Doc. 2014–01465, on page
4345 in the second and third columns
and on page 4346 in the first column, a
30-day notice for an information
collection request published. We are
withdrawing the notice and thereby the
information collection request (ICR). At
this time, we are not submitting the ICR
to OMB and we are not requesting
public comments. The collection is
entitled, ‘‘Imposition of Cost Sharing
Charges Under Medicaid and
Supporting Regulations.’’
Dated: February 4, 2014.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2014–02660 Filed 2–6–14; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2007–D–0077 (formerly
2007D–0213)]
Guidance for Industry; Providing
Regulatory Submissions in Electronic
Format—Receipt Date; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Providing Regulatory
Submissions in Electronic Format—
Receipt Date.’’ This guidance describes
how FDA will assign receipt dates to
certain submissions provided in
electronic format to the Center for Drug
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SUMMARY:
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17:17 Feb 06, 2014
Jkt 232001
Evaluation and Research (CDER) and the
Center for Biologics Evaluation and
Research (CBER). This document
finalizes the guidance of the same name,
which was issued in June 2007.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of the documents to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002 or the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville,
MD 20852–1448. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
the SUPPLEMENTARY INFORMATION section
for electronic access to the documents.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
FOR FURTHER INFORMATION CONTACT:
Edward Hallissey, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1139,
Silver Spring, MD 20993, 301–796–
0420; or Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 5515
Security Lane, Rm. 5130, Rockville, MD
20852, 301–827–6210.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
guidance for industry entitled
‘‘Providing Regulatory Submissions in
Electronic Format—Receipt Date.’’ This
guidance describes how FDA will assign
receipt dates to certain submissions
provided in electronic format or in
physical media to CDER and CBER.
When CDER or CBER receives a
submission, the receipt date may be
used to determine important regulatory
milestones, such as FDA’s 30-day safety
review cycle for an investigative new
drug (IND) application. The guidance
provides clarity regarding when items
submitted electronically are deemed
received by FDA for purposes of such
milestones. Prior to issuance of this
final guidance, certain submissions
received through the electronic
submission gateway (ESG) after 4:30
p.m. were deemed to be received on the
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7463
following business day. With this final
guidance, we are generally eliminating
this 4:30 p.m. cut-off for submissions
received through the ESG Monday
through Friday. However, certain
submissions received through the ESG
on a weekend, Federal holiday, or on a
day when the FDA office that will
review the submission is otherwise not
open for business, will be assigned a
receipt date corresponding to the next
business day.
Occasionally, submissions in
electronic format have technical
deficiencies that prevent FDA from
opening, processing, or archiving the
submission. The guidance explains that
FDA considers a technically deficient
electronic submission to be not received
(i.e., not present at the Agency and not
under review) until all technical
deficiencies are resolved.
On June 5, 2007 (72 FR 31079), FDA
announced the availability of the draft
version of this guidance. The public
comment period closed on August 6,
2007. Several comments were received
from the public, all of which the Agency
considered carefully as it finalized the
guidance and made appropriate
changes. Those changes clarified the
draft guidance and updated the
document to reflect legislative
provisions adopted since the draft was
issued. More specifically, the final
guidance generally eliminates the 4:30
p.m. cut-off for submissions received
through the ESG Monday through
Friday. It also provides guidance on
FDA’s interpretation of a provision in
the Generic Drug User Fee Amendments
of 2012 (GDUFA) concerning the date of
submission for Type II drug master files,
Abbreviated New Drug Applications
(ANDAs), and amendments and
supplements to ANDAs.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on determining the
receipt date for certain submissions in
electronic format or in physical media.
It does not create or confer any rights for
or on any person and does not operate
to bind FDA or the public. An
alternative approach may be used if
such approach satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
The guidance refers to 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
guidance pertains to sponsors and
applicants making regulatory
E:\FR\FM\07FEN1.SGM
07FEN1
]]>Agencies
[Federal Register Volume 79, Number 26 (Friday, February 7, 2014)]
[Notices]
[Page 7463]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-02660]
[[Page 7463]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[Document Identifiers: CMS-R-53]
Agency Information Collection Activities: Submission for OMB
Review
ACTION: Notice; withdrawal.
-----------------------------------------------------------------------
SUMMARY: The Centers for Medicare and Medicaid Services published a
document in the Federal Register on January 27, 2014, concerning the
submission of an information collection request for OMB review and a
request for public comments. The document was published in error.
Withdrawal
In the Federal Register of January 27, 2014, in FR Doc. 2014-01465,
on page 4345 in the second and third columns and on page 4346 in the
first column, a 30-day notice for an information collection request
published. We are withdrawing the notice and thereby the information
collection request (ICR). At this time, we are not submitting the ICR
to OMB and we are not requesting public comments. The collection is
entitled, ``Imposition of Cost Sharing Charges Under Medicaid and
Supporting Regulations.''
Dated: February 4, 2014.
Martique Jones,
Deputy Director, Regulations Development Group, Office of Strategic
Operations and Regulatory Affairs.
[FR Doc. 2014-02660 Filed 2-6-14; 8:45 am]
BILLING CODE 4120-01-P
