Reporting of Pregnancy Success Rates From Assisted Reproductive Technology (ART) Programs; Proposed Modifications to Data Collection Fields and Data Validation Procedures; Request for Comment, 83131-83133 [2023-26137]
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Federal Register / Vol. 88, No. 227 / Tuesday, November 28, 2023 / Notices
payment protections until the
contractor’s obligation is fulfilled. The
contracting officer uses the information
on the SF 28 to determine the
acceptability of individuals proposed as
sureties.
C. Annual Burden
Respondents: 14,259.
Total Annual Responses: 14,269.
Total Burden Hours: 14,255.
D. Public Comment
A 60-day notice was published in the
Federal Register at 88 FR 64433, on
September 19, 2023. No comments were
received.
Obtaining Copies: Requesters may
obtain a copy of the information
collection documents from the GSA
Regulatory Secretariat Division, by
calling 202–501–4755 or emailing
GSARegSec@gsa.gov. Please cite OMB
Control No. 9000–0001, Certain Federal
Acquisition Regulation Part 28
Requirements.
William Clark,
Director, Office of Governmentwide
Acquisition Policy, Office of Acquisition
Policy, Office of Governmentwide Policy.
[FR Doc. 2023–26176 Filed 11–27–23; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF DEFENSE
GENERAL SERVICES
ADMINISTRATION
NATIONAL AERONAUTICS AND
SPACE ADMINISTRATION
[OMB Control No. 9000–0037; Docket No.
2023–0053; Sequence No. 9]
Submission for OMB Review;
Presolicitation Notice and Response
Department of Defense (DOD),
General Services Administration (GSA),
and National Aeronautics and Space
Administration (NASA).
ACTION: Notice.
AGENCY:
Under the provisions of the
Paperwork Reduction Act, the
Regulatory Secretariat Division has
submitted to the Office of Management
and Budget (OMB) a request to review
and approve a revision of a previously
approved information collection
requirement regarding presolicitation
notice and response.
DATES: Submit comments on or before
December 28, 2023.
ADDRESSES: Written comments and
recommendations for this information
collection should be sent within 30 days
of publication of this notice to
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
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17:19 Nov 27, 2023
Jkt 262001
www.reginfo.gov/public/do/PRAMain.
Find this particular information
collection by selecting ‘‘Currently under
Review—Open for Public Comments’’ or
by using the search function.
FOR FURTHER INFORMATION CONTACT:
Zenaida Delgado, Procurement Analyst,
at telephone 202–969–7207, or
zenaida.delgado@gsa.gov.
SUPPLEMENTARY INFORMATION:
A. OMB Control Number, Title, and
Any Associated Form(s)
9000–0037, Presolicitation Notice and
Response.
B. Need and Uses
This clearance covers the information
that offerors must submit to comply
with the following Federal Acquisition
Regulation (FAR) requirements:
• FAR 14.205. For sealed bidding,
presolicitation notices briefly describe
requirements and provide other
essential information to enable potential
bidders to determine whether they have
an interest in the invitation and if
appropriate, respond by communicating
their interest in receiving the invitation
for bid.
• FAR 15.201(c). For contracting by
negotiation, presolicitation notices
provide a means of early exchanges of
information about future acquisitions
between Government and industry, to
which potential offerors may respond
with feedback concerning acquisition
strategy, terms and conditions, and any
other concerns or questions.
• FAR 36.213–2. For construction
contracts, presolicitation notices are
required for construction requirements
in excess of the simplified acquisition
threshold to communicate essential
information on the requirements, to
which potential bidders may respond by
communicating their interest in
receiving the invitation for bid.
Presolicitation notices are used by the
Government to inform, and, where
specified, solicit a response from
potential offerors or bidders. The
primary purposes of the notices are to
improve small business access to
acquisition information and enhance
competition by identifying contracting
and subcontracting opportunities.
The contracting officer will use the
information as follows:
• For sealed bidding, to include
interested bidders in the distribution of
the invitations for bids; and
• For contracting by negotiation, to
consider the industry feedback in
shaping the acquisition strategy.
C. Annual Burden
Respondents: 143,218.
Total Annual Responses: 429,654.
PO 00000
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83131
Total Burden Hours: 34,372.
D. Public Comment
A 60-day notice was published in the
Federal Register at 88 FR 64434, on
September 19, 2023. No comments were
received.
Obtaining Copies: Requesters may
obtain a copy of the information
collection documents from the GSA
Regulatory Secretariat Division, by
calling 202–501–4755 or emailing
GSARegSec@gsa.gov. Please cite OMB
Control No. 9000–0037, Presolicitation
Notice and Response.
William Clark,
Director, Office of Governmentwide
Acquisition Policy, Office of Acquisition
Policy, Office of Governmentwide Policy.
[FR Doc. 2023–26177 Filed 11–27–23; 8:45 am]
BILLING CODE 6820–EP–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
[Docket No. CDC–2023–0093]
Reporting of Pregnancy Success Rates
From Assisted Reproductive
Technology (ART) Programs;
Proposed Modifications to Data
Collection Fields and Data Validation
Procedures; Request for Comment
Centers for Disease Control and
Prevention (CDC), Department of Health
and Human Services (HHS).
ACTION: Request for comment.
AGENCY:
The Centers for Disease
Control and Prevention (CDC) in the
Department of Health and Human
Services (HHS) announces the opening
of a docket to obtain comment on and
review of proposed modifications to
data collection fields for reporting of
pregnancy success rates from assisted
reproductive technology (ART)
programs and proposed modifications to
data validation procedures. This
reporting is required by the Fertility
Clinic Success Rate and Certification
Act of 1992 (FCSRCA).
DATES: Written comments must be
received on or before January 29, 2024.
ADDRESSES: You may submit comments,
identified by Docket No. CDC–2023–
0093 by either of the methods listed
below.
Do not submit comments by email.
CDC does not accept comments by
email.
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
SUMMARY:
E:\FR\FM\28NON1.SGM
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83132
Federal Register / Vol. 88, No. 227 / Tuesday, November 28, 2023 / Notices
• Mail: Division of Reproductive
Health, National Center for Chronic
Disease Prevention and Health
Promotion, Centers for Disease Control
and Prevention, 4770 Buford Highway
NE, Mailstop S107–2, Atlanta, Georgia
30341; Attention: Assisted Reproductive
Technology Surveillance and Research
Team.
Instructions: All submissions received
must include the agency name and
Docket Number. All relevant comments
received will be posted without change
to https://regulations.gov, including any
personal information provided. For
access to the docket to read background
documents or comments received, go to
https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Mithi Sunderam, Division of
Reproductive Health, National Center
for Chronic Disease Prevention and
Health Promotion, Centers for Disease
Control and Prevention, 4770 Buford
Highway NE, Mailstop S107–2, Atlanta,
Georgia 30341; Telephone: 1–800–232–
4636; Email: ARTinfo@cdc.gov.
SUPPLEMENTARY INFORMATION:
lotter on DSK11XQN23PROD with NOTICES1
Public Participation
Interested persons or organizations
are invited to participate by submitting
written views, recommendations, and
data. In addition, CDC invites comments
specifically on the following
modifications to (1) data collection
fields for reporting of pregnancy success
rates from assisted reproductive
technology (ART) programs; and (2) data
validation procedures regarding the
following proposals in this document:
• CDC proposal to remove the
requirement for clinics to report dosage
information for fertility medications
including Clomiphene, Letrozole, and
long-acting FSH.
• CDC proposal to remove the
requirement for clinics to report
information on research cycle study
type.
• CDC proposal to add the
requirement for clinics to report date of
cryopreservation for fresh embryos.
• CDC proposal not to pursue targeted
validation of clinics and identification
of major data discrepancies.
Please note that comments received,
including attachments and other
supporting materials, are part of the
public record and are subject to public
disclosure. Comments will be posted on
https://www.regulations.gov. Do not
include any information in your
comment or supporting materials that
you consider confidential or
inappropriate for public disclosure. If
you include your name, contact
information, or other information that
VerDate Sep<11>2014
17:19 Nov 27, 2023
Jkt 262001
identifies you in the body of your
comments, that information will be on
public display. CDC will review all
submissions and may choose to redact,
or withhold, submissions containing
private or proprietary information such
as Social Security numbers, medical
information, inappropriate language, or
duplicate/near duplicate examples of a
mass-mail campaign. Do not submit
comments by email. CDC does not
accept comments by email.
Background
On August 26, 2015, HHS/CDC
published a notice in the Federal
Register (80 FR 51811) announcing the
overall reporting requirements of the
National ART Surveillance System. This
notice described who shall report to
HHS/CDC the process for reporting by
each ART program; the data to be
reported; the process for external
validation of clinic data; and the
contents of the published reports. CDC
has obtained approval from the Office of
Management and Budget under the
Paperwork Reduction Act to collect this
information which is needed to
determine the annual pregnancy success
rates for each clinic that provides ART
services. This data collection is
approved under OMB Control Number
0920–0556, expiration date: December
31, 2024. CDC subsequently published a
notice in the Federal Register on
clarifications and modifications on
December 15, 2016 (81 FR 90854), and
a notice on clarifications and
corrections on November 5, 2019 (84 FR
59625). In 2021, CDC published a notice
in the Federal Register (86 FR 20496) on
changes to data validation of ART
clinics. Subsequently, CDC published a
notice in the Federal Register on June
10, 2022 (87 FR 35555) that added data
collection fields and modified reporting
requirements. The purpose of the
subject notice is to (1) update data
collection fields to reflect changes in
ART practice that may impact
pregnancy success rates; and (2) update
the ART data validation process. This
notice provides opportunity for public
review and comment for the proposed
modifications to data collection fields
and data validation procedures.
Proposed Modifications to Data
Collection Fields
CDC is currently collecting
information on Clomiphene dosage,
Letrozole dosage, and other oral
medication dosage (80 FR 51811;
Section III ‘‘What to Report’’: F
‘‘Stimulation and Retrieval’’).
Clomiphene and Letrozole are
established treatment options for
ovulation induction and may be
PO 00000
Frm 00060
Fmt 4703
Sfmt 4703
administered based on patient
diagnostics to increase the chances of
ovulation and pregnancy. Other oral
medications such as insulin-sensitizing
agents may be used in specific groups of
patients. Therefore, it is important to
monitor the type of medication used,
and CDC will continue to collect
information on whether Clomiphene,
Letrozole or other oral medication were
used. However, dosage regimens for
these medications follow established
guidelines and are less likely to show
variability in how they are
administered. Given these treatment
protocols, collection of these data can be
streamlined. In addition, CDC is
currently collecting dosage information
on long-acting follicle stimulating
hormone (FSH) medication. Since this
medication is no longer used in ART
practice, CDC proposes discontinuing
the collection of information on this
medication. Therefore, CDC proposes to
remove the requirement for ART clinics
to report associated dosage information
related to (1) Clomiphene, Letrozole, or
other oral medication; and (2) longacting FSH. Deletion: Clomiphene
dosage (Total mgs), Letrozole dosage
(Total mgs), other oral medication
dosage, long-acting FSH (Total mgs).
CDC is currently collecting
information on the type of research
cycle performed by ART clinics (80 FR
51811; Section III ‘‘What to Report’’: G
‘‘Laboratory Information’’). Only a small
number of research cycles are reported
to CDC each year (i.e., 10 cycles in
reporting year 2019, 7 cycles in
reporting year 2020, and 0 cycles in
reporting year 2021). CDC will continue
to collect information on whether a
cycle can be classified as a research
cycle. CDC proposes to remove the
requirement for clinics to report the
research cycle study type, as only a
small number of research cycles are
performed each year. Deletion: Research
cycle study type—if the cycle was a
research cycle. This deletion will apply
to all data fields for research study
types: Device study, Protocol study,
Pharmaceutical study, Laboratory
technique, Other research.
CDC is currently collecting
information on fresh and frozen-embryo
transfer procedures (80 FR 51811;
Section III ‘‘What to Report’’: H
‘‘Transfer Information’’). Embryo stage
at the time of transfer is an important
predictor of pregnancy success rates.
For fresh-embryo transfer procedures,
embryo stage can be determined by
calculating the difference between the
date of transfer and the date of oocyte
retrieval. Both dates are currently
collected. However, if fresh embryos
were cryopreserved instead of being
E:\FR\FM\28NON1.SGM
28NON1
Federal Register / Vol. 88, No. 227 / Tuesday, November 28, 2023 / Notices
utilized for a fresh transfer, the date of
cryopreservation is not currently
collected. In recent years, frozen-embryo
transfers have become more prevalent as
they may improve pregnancy success
rates in certain groups of ART patients.
For frozen-embryo transfers, the date at
which fresh embryos were
cryopreserved (with the date of oocyte
retrieval) can be used to determine the
stage of the embryo at the time of
cryopreservation, which is an important
predictor of ART success. Therefore,
CDC proposes to add the date of freshembryo cryopreservation to the
currently collected information as it will
allow classification of embryo stage for
frozen-embryo transfers and improve
the reporting of factors that impact ART
success rates. Addition: Date fresh
embryos were cryopreserved—this date
is to be reported for all frozen-embryo
transfers.
Proposed Modifications to Data
Validation Procedures
lotter on DSK11XQN23PROD with NOTICES1
Pursuant to the previous FRN notice
(86 FR 20496), CDC proposed to
conduct targeted validation of ART
clinics to better capture systematic
reporting errors by assessing certain
reporting characteristics that may
predict erroneously inflated ART
success rates. In addition, CDC
proposed to remove a clinic’s reported
success rates from the annual ART
reports if major data discrepancies were
identified. Identifying major data
discrepancies would require the review
of a larger number of clinic records at
select clinics, thereby increasing data
collection burden for clinics. Given the
additional burden, CDC will not pursue
implementation of targeted validation of
ART clinics and identification of major
discrepancies during data validation.
CDC will continue to calculate
discrepancy rates for key variables and
provide feedback to clinics to improve
the reporting of data used to report
success rates as described in the FRN
notice (80 FR 51811). In addition, CDC
will continue removing a clinic’s
reported success rates from annual ART
reports if the clinic was selected for
annual ART data validation but
declined to participate as described in
the FRN notice (86 FR 20496).
Tiffany Brown,
Executive Secretary, Centers for Disease
Control and Prevention.
[FR Doc. 2023–26137 Filed 11–27–23; 8:45 am]
BILLING CODE 4163–18–P
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Jkt 262001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[Document Identifier: CMS–102 and CMS–
105]
Agency Information Collection
Activities: Proposed Collection;
Comment Request
Centers for Medicare &
Medicaid Services, Health and Human
Services (HHS).
ACTION: Notice.
AGENCY:
The Centers for Medicare &
Medicaid Services (CMS) is announcing
an opportunity for the public to
comment on CMS’ intention to collect
information from the public. Under the
Paperwork Reduction Act of 1995
(PRA), federal agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information (including each proposed
extension or reinstatement of an existing
collection of information) and to allow
60 days for public comment on the
proposed action. Interested persons are
invited to send comments regarding our
burden estimates or any other aspect of
this collection of information, including
the necessity and utility of the proposed
information collection for the proper
performance of the agency’s functions,
the accuracy of the estimated burden,
ways to enhance the quality, utility, and
clarity of the information to be
collected, and the use of automated
collection techniques or other forms of
information technology to minimize the
information collection burden.
DATES: Comments must be received by
January 29, 2024.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number: __, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
SUMMARY:
PO 00000
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83133
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, please access the CMS PRA
website by copying and pasting the
following web address into your web
browser: https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
CMS–102 and CMS–105—CLIA Budget
Workload Reports and Supporting
Regulations in 42 CFR 493.1–.2001
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.
The term ‘‘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
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Reinstatement with change of a
previously approved collection; Title of
Information Collection: CLIA Budget
Workload Reports and Supporting
Regulations in 42 CFR 493.1–.2001; Use:
The Clinical Laboratory Improvement
Amendments of 1988 (CLIA), Public
Law 100–578 were enacted on October
31, 1988. Provisions of this law
mandated by Congress require entities
(with few exceptions) that test human
specimens be subject to Federal
regulation and have in effect a
certificate issued by the Department of
Health and Human Services. CLIA
mandates that fees must be paid by each
laboratory to obtain or renew a
certificate and for the cost of
E:\FR\FM\28NON1.SGM
28NON1
]]>Agencies
[Federal Register Volume 88, Number 227 (Tuesday, November 28, 2023)]
[Notices]
[Pages 83131-83133]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-26137]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Disease Control and Prevention
[Docket No. CDC-2023-0093]
Reporting of Pregnancy Success Rates From Assisted Reproductive
Technology (ART) Programs; Proposed Modifications to Data Collection
Fields and Data Validation Procedures; Request for Comment
AGENCY: Centers for Disease Control and Prevention (CDC), Department of
Health and Human Services (HHS).
ACTION: Request for comment.
-----------------------------------------------------------------------
SUMMARY: The Centers for Disease Control and Prevention (CDC) in the
Department of Health and Human Services (HHS) announces the opening of
a docket to obtain comment on and review of proposed modifications to
data collection fields for reporting of pregnancy success rates from
assisted reproductive technology (ART) programs and proposed
modifications to data validation procedures. This reporting is required
by the Fertility Clinic Success Rate and Certification Act of 1992
(FCSRCA).
DATES: Written comments must be received on or before January 29, 2024.
ADDRESSES: You may submit comments, identified by Docket No. CDC-2023-
0093 by either of the methods listed below.
Do not submit comments by email. CDC does not accept comments by
email.
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments.
[[Page 83132]]
Mail: Division of Reproductive Health, National Center for
Chronic Disease Prevention and Health Promotion, Centers for Disease
Control and Prevention, 4770 Buford Highway NE, Mailstop S107-2,
Atlanta, Georgia 30341; Attention: Assisted Reproductive Technology
Surveillance and Research Team.
Instructions: All submissions received must include the agency name
and Docket Number. All relevant comments received will be posted
without change to https://regulations.gov, including any personal
information provided. For access to the docket to read background
documents or comments received, go to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Mithi Sunderam, Division of
Reproductive Health, National Center for Chronic Disease Prevention and
Health Promotion, Centers for Disease Control and Prevention, 4770
Buford Highway NE, Mailstop S107-2, Atlanta, Georgia 30341; Telephone:
1-800-232-4636; Email: [email protected].
SUPPLEMENTARY INFORMATION:
Public Participation
Interested persons or organizations are invited to participate by
submitting written views, recommendations, and data. In addition, CDC
invites comments specifically on the following modifications to (1)
data collection fields for reporting of pregnancy success rates from
assisted reproductive technology (ART) programs; and (2) data
validation procedures regarding the following proposals in this
document:
CDC proposal to remove the requirement for clinics to
report dosage information for fertility medications including
Clomiphene, Letrozole, and long-acting FSH.
CDC proposal to remove the requirement for clinics to
report information on research cycle study type.
CDC proposal to add the requirement for clinics to report
date of cryopreservation for fresh embryos.
CDC proposal not to pursue targeted validation of clinics
and identification of major data discrepancies.
Please note that comments received, including attachments and other
supporting materials, are part of the public record and are subject to
public disclosure. Comments will be posted on https://www.regulations.gov. Do not include any information in your comment or
supporting materials that you consider confidential or inappropriate
for public disclosure. If you include your name, contact information,
or other information that identifies you in the body of your comments,
that information will be on public display. CDC will review all
submissions and may choose to redact, or withhold, submissions
containing private or proprietary information such as Social Security
numbers, medical information, inappropriate language, or duplicate/near
duplicate examples of a mass-mail campaign. Do not submit comments by
email. CDC does not accept comments by email.
Background
On August 26, 2015, HHS/CDC published a notice in the Federal
Register (80 FR 51811) announcing the overall reporting requirements of
the National ART Surveillance System. This notice described who shall
report to HHS/CDC the process for reporting by each ART program; the
data to be reported; the process for external validation of clinic
data; and the contents of the published reports. CDC has obtained
approval from the Office of Management and Budget under the Paperwork
Reduction Act to collect this information which is needed to determine
the annual pregnancy success rates for each clinic that provides ART
services. This data collection is approved under OMB Control Number
0920-0556, expiration date: December 31, 2024. CDC subsequently
published a notice in the Federal Register on clarifications and
modifications on December 15, 2016 (81 FR 90854), and a notice on
clarifications and corrections on November 5, 2019 (84 FR 59625). In
2021, CDC published a notice in the Federal Register (86 FR 20496) on
changes to data validation of ART clinics. Subsequently, CDC published
a notice in the Federal Register on June 10, 2022 (87 FR 35555) that
added data collection fields and modified reporting requirements. The
purpose of the subject notice is to (1) update data collection fields
to reflect changes in ART practice that may impact pregnancy success
rates; and (2) update the ART data validation process. This notice
provides opportunity for public review and comment for the proposed
modifications to data collection fields and data validation procedures.
Proposed Modifications to Data Collection Fields
CDC is currently collecting information on Clomiphene dosage,
Letrozole dosage, and other oral medication dosage (80 FR 51811;
Section III ``What to Report'': F ``Stimulation and Retrieval'').
Clomiphene and Letrozole are established treatment options for
ovulation induction and may be administered based on patient
diagnostics to increase the chances of ovulation and pregnancy. Other
oral medications such as insulin-sensitizing agents may be used in
specific groups of patients. Therefore, it is important to monitor the
type of medication used, and CDC will continue to collect information
on whether Clomiphene, Letrozole or other oral medication were used.
However, dosage regimens for these medications follow established
guidelines and are less likely to show variability in how they are
administered. Given these treatment protocols, collection of these data
can be streamlined. In addition, CDC is currently collecting dosage
information on long-acting follicle stimulating hormone (FSH)
medication. Since this medication is no longer used in ART practice,
CDC proposes discontinuing the collection of information on this
medication. Therefore, CDC proposes to remove the requirement for ART
clinics to report associated dosage information related to (1)
Clomiphene, Letrozole, or other oral medication; and (2) long-acting
FSH. Deletion: Clomiphene dosage (Total mgs), Letrozole dosage (Total
mgs), other oral medication dosage, long-acting FSH (Total mgs).
CDC is currently collecting information on the type of research
cycle performed by ART clinics (80 FR 51811; Section III ``What to
Report'': G ``Laboratory Information''). Only a small number of
research cycles are reported to CDC each year (i.e., 10 cycles in
reporting year 2019, 7 cycles in reporting year 2020, and 0 cycles in
reporting year 2021). CDC will continue to collect information on
whether a cycle can be classified as a research cycle. CDC proposes to
remove the requirement for clinics to report the research cycle study
type, as only a small number of research cycles are performed each
year. Deletion: Research cycle study type--if the cycle was a research
cycle. This deletion will apply to all data fields for research study
types: Device study, Protocol study, Pharmaceutical study, Laboratory
technique, Other research.
CDC is currently collecting information on fresh and frozen-embryo
transfer procedures (80 FR 51811; Section III ``What to Report'': H
``Transfer Information''). Embryo stage at the time of transfer is an
important predictor of pregnancy success rates. For fresh-embryo
transfer procedures, embryo stage can be determined by calculating the
difference between the date of transfer and the date of oocyte
retrieval. Both dates are currently collected. However, if fresh
embryos were cryopreserved instead of being
[[Page 83133]]
utilized for a fresh transfer, the date of cryopreservation is not
currently collected. In recent years, frozen-embryo transfers have
become more prevalent as they may improve pregnancy success rates in
certain groups of ART patients. For frozen-embryo transfers, the date
at which fresh embryos were cryopreserved (with the date of oocyte
retrieval) can be used to determine the stage of the embryo at the time
of cryopreservation, which is an important predictor of ART success.
Therefore, CDC proposes to add the date of fresh-embryo
cryopreservation to the currently collected information as it will
allow classification of embryo stage for frozen-embryo transfers and
improve the reporting of factors that impact ART success rates.
Addition: Date fresh embryos were cryopreserved--this date is to be
reported for all frozen-embryo transfers.
Proposed Modifications to Data Validation Procedures
Pursuant to the previous FRN notice (86 FR 20496), CDC proposed to
conduct targeted validation of ART clinics to better capture systematic
reporting errors by assessing certain reporting characteristics that
may predict erroneously inflated ART success rates. In addition, CDC
proposed to remove a clinic's reported success rates from the annual
ART reports if major data discrepancies were identified. Identifying
major data discrepancies would require the review of a larger number of
clinic records at select clinics, thereby increasing data collection
burden for clinics. Given the additional burden, CDC will not pursue
implementation of targeted validation of ART clinics and identification
of major discrepancies during data validation. CDC will continue to
calculate discrepancy rates for key variables and provide feedback to
clinics to improve the reporting of data used to report success rates
as described in the FRN notice (80 FR 51811). In addition, CDC will
continue removing a clinic's reported success rates from annual ART
reports if the clinic was selected for annual ART data validation but
declined to participate as described in the FRN notice (86 FR 20496).
Tiffany Brown,
Executive Secretary, Centers for Disease Control and Prevention.
[FR Doc. 2023-26137 Filed 11-27-23; 8:45 am]
BILLING CODE 4163-18-P
