Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Exports: Notification and Recordkeeping Requirements, 23055-23056 [2019-10537]
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Federal Register / Vol. 84, No. 98 / Tuesday, May 21, 2019 / Notices
appropriate licensing bodies and
ombudsmen programs.
• A description of the organization’s
policies and procedures with respect to
the withholding or removal of
accreditation for failure to meet the
accreditation organization’s standards or
requirements, and other actions the
organization takes in response to
noncompliance with its standards and
requirements.
• A description of all types (for
example, full, partial) and categories (for
example, provisional, conditional,
temporary) of accreditation offered by
the organization, the duration of each
type and category of accreditation and a
statement identifying the types and
categories that would serve as a basis for
accreditation if CMS approves the
accreditation organization.
• A list of all currently accredited MA
organizations and the type, category,
and expiration date of the accreditation
held by each of them.
• A list of all full and partial
accreditation surveys scheduled to be
performed by the accreditation
organization.
• The name and address of each
person with an ownership or control
interest in the accreditation
organization.
• CMS also considers URAC’s past
performance in the deeming program
and results of recent deeming validation
reviews, or look-behind audits
conducted as part of continuing federal
oversight of the deeming program under
§ 422.157(d).
In accordance with section
1865(a)(3)(A) of the Act, the December
26, 2018 proposed notice (83 FR 66271)
also solicited public comments
regarding whether URAC’s requirements
met or exceeded the Medicare
conditions of participation as an
accrediting organization for MA HMOs
and PPOs. We received no public
comments in response to the December
26, 2018 proposed notice (83 FR 66271).
III. Provisions of the Final Notice
jbell on DSK3GLQ082PROD with NOTICES
A. Differences Between URAC’s
Standards and Requirements for
Accreditation and Medicare’s
Conditions and Survey Requirements
We compared the standards and
survey process contained in URAC’s
application with the Medicare
conditions for accreditation. Our review
and evaluation of URAC’s application
for continued CMS approval were
conducted as described in section II. of
this final notice, and yielded the
following:
• URAC amended its crosswalk to
ensure current URAC standards are
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17:50 May 20, 2019
Jkt 247001
clearly cross-walked to our regulations,
including the following regulatory
requirements for Quality Improvement;
Antidiscrimination, Confidentiality and
Accuracy of Enrollee Records,
Information on Advanced Directives,
and Provider Participation Rules:
§§ 422.101(f); 422.205(b); 422.110(a)
through (b); 422.118(a); 422.128(b);
422.152(a) and (b), (e) through (g);
422.202(a) through (d); 422.206(a)
through (b); 422.208(c), (e) through (g);
422.210(b); 422.212(a) through (d); and
422.216(f) through (h).
• URAC submitted additional
information and/or documentation
regarding its survey process that was
intended to address: § 422.158(a)(2),
(a)(3)(ii), (a)(3)(iii)(A) through (C),
(a)(4)(ii) and (iii), (a)(6) through (10),
and (b)(2).
B. Term of Approval
Based on the review and observations
described in section II. of this final
notice, we have determined that URAC’s
accreditation program requirements
meet or exceed our requirements.
Therefore, we approve URAC as a
national accreditation organization with
deeming authority for MA HMOs and
PPOs, effective May 21, 2019.
V. Collection of Information
Requirements
This notice announces the new term
of approval for the URAC. It does not
impose any information collection
requirements (that is, reporting,
recordkeeping or third-party disclosure
requirements). Consequently, there is no
need for review by the Office of
Management and Budget under the
authority of the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.).
VI. Regulatory Impact Statement
In accordance with the provisions of
Executive Order 12866, this regulation
was not reviewed by the Office of
Management and Budget.
Dated: May 2, 2019.
Seema Verma,
Administrator, Centers for Medicare &
Medicaid Services.
[FR Doc. 2019–10586 Filed 5–20–19; 8:45 am]
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23055
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2014–N–0801]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Exports:
Notification and Recordkeeping
Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 20,
2019.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0482. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
Ila
S. Mizrachi, Office of Operations, Food
and Drug Administration, Three White
Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–7726, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
Exports: Notification and
Recordkeeping Requirements—21 CFR
1.101
OMB Control Number 0910–0482—
Extension
Section 801 of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
381) charges the Secretary of Health and
Human Services, through FDA, with the
responsibility of helping to ensure that
exports of unapproved new drugs,
biologics, devices, animal drugs, food,
cosmetics, and tobacco products which
are not to be sold in the United States
E:\FR\FM\21MYN1.SGM
21MYN1
23056
Federal Register / Vol. 84, No. 98 / Tuesday, May 21, 2019 / Notices
meet the requirements of the country to
which the product is to be exported.
The respondents to this information
collection are exporters who have
notified FDA of their intent to export
unapproved products that may not be
sold or offered for sale in domestic
commerce in the United States as
allowed under section 801(e) of the
FD&C Act. In general, the notification
identifies the product being exported
(e.g., name, description, and in some
cases, country of destination) and
specifies where the notifications were
sent. These notifications are sent only
for an initial export. Subsequent exports
of the same product to the same
destination or to certain countries
identified in section 802(b) of the FD&C
Act (21 U.S.C. 382(b)) would not result
in a notification to FDA.
The recordkeepers for this
information collection are exporters of
products that may not be sold in the
United States who are regulated by the
following FDA Centers: Center for Drug
Evaluation and Research (CDER); Center
for Biologics Evaluation and Research
(CBER); Center for Devices and
Radiological Health (CDRH); Center for
Veterinary Medicine (CVM); Center for
Food Safety and Applied Nutrition
(CFSAN); and Center for Tobacco
Products (CTP). Respondents to this
collection of information maintain
records demonstrating their compliance
with the requirements in 21 CFR 1.101.
In the Federal Register of February
15, 2019 (84 FR 4473), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
1.101(d) (CBER) ........................................................
1.101(d) (CDER) ........................................................
1.101(d) (CDRH) ........................................................
5
5
160
92
180
1
460
900
160
15
15
15
6,900
13,500
2,400
Total ....................................................................
..........................
..........................
..........................
..........................
22,800
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1
Number of
recordkeepers
21 CFR section
Total
annual
records
Average
burden per
recordkeeping
Total hours
1.101 (b), (c), (e) (CBER, CDER, CDRH, CFSAN,
and CVM) ...............................................................
1.101(b) Office of International Programs only .........
1.101(b) (currently regulated Tobacco Products) ......
320
1
322
3
189
3
960
189
966
22
22
22
21,120
4,158
21,252
Total ....................................................................
..........................
..........................
..........................
..........................
46,530
1 There
jbell on DSK3GLQ082PROD with NOTICES
Number of
records per
recordkeeper
are no capital costs or operating and maintenance costs associated with this collection of information.
We have adjusted our burden
estimate, which has resulted in an
overall decrease of 129,543 hours to the
currently approved burden. The
reporting burden estimate for CDRH has
been adjusted to correct an error and
corresponding miscalculation in the
previous burden estimate and has been
updated based on recent internal data.
This adjustment contributed to the
overall burden estimate reduction by
eliminating 8,030 responses and
120,450 hours from the reporting
burden estimate. CBER’s estimated
reporting burden for the information
collection in table 1 reflects a decrease
of 7,575 hours and a corresponding
decrease of total annual responses (193
to 92). We attribute this adjustment to
a normal variation in the number of
submissions we received over the last
few years. CTP’s current number of
respondents and recordkeeping burden
hours in table 2 are expected to decrease
by 23 respondents and 1,518 hours. This
is based on summary derived from the
VerDate Sep<11>2014
17:50 May 20, 2019
Jkt 247001
monthly operational reports that
manufacturers and importers of tobacco
products are required to file with the
Alcohol and Tobacco Tax and Trade
Bureau.
Dated: May 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–10537 Filed 5–20–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the National Vaccine
Advisory Committee
National Vaccine Program
Office, Office of the Assistant Secretary
for Health, Office of the Secretary,
Department of Health and Human
Services.
AGENCY:
ACTION:
PO 00000
Notice.
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As stipulated by the Federal
Advisory Committee Act, the
Department of Health and Human
Services (HHS) is hereby giving notice
that a meeting is scheduled to be held
of the National Vaccine Advisory
Committee (NVAC). The meeting will be
open to the public via teleconference; a
public comment session will be held
during the meeting.
DATES: The meeting will be held on
Tuesday and Wednesday, June 4–5,
2019. The confirmed meeting times and
agenda will be posted on the NVAC
website at https://www.hhs.gov/nvpo/
nvac/meetings/ as soon as
they become available.
ADDRESSES: Instructions regarding
attending this meeting will be posted
one week prior to the meeting at: https://
www.hhs.gov/nvpo/nvac/meetings/
index.html. Pre-registration is required
for members of the public who wish to
attend the meeting and who wish to
participate in the public comment
session. Individuals who wish to attend
SUMMARY:
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]]>Agencies
[Federal Register Volume 84, Number 98 (Tuesday, May 21, 2019)]
[Notices]
[Pages 23055-23056]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-10537]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2014-N-0801]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Exports: Notification
and Recordkeeping Requirements
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Fax written comments on the collection of information by June
20, 2019.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
Fax: 202-395-7285, or emailed to [email protected]. All
comments should be identified with the OMB control number 0910-0482.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-7726,
[email protected].
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Exports: Notification and Recordkeeping Requirements--21 CFR 1.101
OMB Control Number 0910-0482--Extension
Section 801 of the Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 381) charges the Secretary of Health and Human Services,
through FDA, with the responsibility of helping to ensure that exports
of unapproved new drugs, biologics, devices, animal drugs, food,
cosmetics, and tobacco products which are not to be sold in the United
States
[[Page 23056]]
meet the requirements of the country to which the product is to be
exported. The respondents to this information collection are exporters
who have notified FDA of their intent to export unapproved products
that may not be sold or offered for sale in domestic commerce in the
United States as allowed under section 801(e) of the FD&C Act. In
general, the notification identifies the product being exported (e.g.,
name, description, and in some cases, country of destination) and
specifies where the notifications were sent. These notifications are
sent only for an initial export. Subsequent exports of the same product
to the same destination or to certain countries identified in section
802(b) of the FD&C Act (21 U.S.C. 382(b)) would not result in a
notification to FDA.
The recordkeepers for this information collection are exporters of
products that may not be sold in the United States who are regulated by
the following FDA Centers: Center for Drug Evaluation and Research
(CDER); Center for Biologics Evaluation and Research (CBER); Center for
Devices and Radiological Health (CDRH); Center for Veterinary Medicine
(CVM); Center for Food Safety and Applied Nutrition (CFSAN); and Center
for Tobacco Products (CTP). Respondents to this collection of
information maintain records demonstrating their compliance with the
requirements in 21 CFR 1.101.
In the Federal Register of February 15, 2019 (84 FR 4473), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
21 CFR section Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.101(d) (CBER).................................................... 5 92 460 15 6,900
1.101(d) (CDER).................................................... 5 180 900 15 13,500
1.101(d) (CDRH).................................................... 160 1 160 15 2,400
------------------------------------------------------------------------------------
Total.......................................................... ............... ............... ............... ............... 22,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Average burden
21 CFR section Number of records per Total annual per Total hours
recordkeepers recordkeeper records recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.101 (b), (c), (e) (CBER, CDER, CDRH, CFSAN, and CVM)............. 320 3 960 22 21,120
1.101(b) Office of International Programs only..................... 1 189 189 22 4,158
1.101(b) (currently regulated Tobacco Products).................... 322 3 966 22 21,252
------------------------------------------------------------------------------------
Total.......................................................... ............... ............... ............... ............... 46,530
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
We have adjusted our burden estimate, which has resulted in an
overall decrease of 129,543 hours to the currently approved burden. The
reporting burden estimate for CDRH has been adjusted to correct an
error and corresponding miscalculation in the previous burden estimate
and has been updated based on recent internal data. This adjustment
contributed to the overall burden estimate reduction by eliminating
8,030 responses and 120,450 hours from the reporting burden estimate.
CBER's estimated reporting burden for the information collection in
table 1 reflects a decrease of 7,575 hours and a corresponding decrease
of total annual responses (193 to 92). We attribute this adjustment to
a normal variation in the number of submissions we received over the
last few years. CTP's current number of respondents and recordkeeping
burden hours in table 2 are expected to decrease by 23 respondents and
1,518 hours. This is based on summary derived from the monthly
operational reports that manufacturers and importers of tobacco
products are required to file with the Alcohol and Tobacco Tax and
Trade Bureau.
Dated: May 16, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-10537 Filed 5-20-19; 8:45 am]
BILLING CODE 4164-01-P
