Agency Information Collection Activities; Proposed Collection; Comment Request; Pregnancy Exposure Registry Enrollment Project: A Survey of Healthcare Providers To Advance Pregnancy Safety Data Collection and Improve Health Communications, 32447-32450 [2024-09028]
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Federal Register / Vol. 89, No. 82 / Friday, April 26, 2024 / Notices
may also include firms that withdrew an
application or submission. Transfer
request forms target respondents who
submitted payment for a user fee cover
sheet or invoice and need that payment
to be re-applied to another cover sheet
or invoice (transfer of funds).
The electronic user fee payment
request forms streamline the refund and
transfer processes, facilitate processing,
and improve the tracking of refund or
transfer requests. The burden for this
collection of information is the same for
all customers (small and large
organizations). The information being
requested or required has been held to
the absolute minimum required for the
intended use of the data. Respondents
32447
are able to request a user fee payment
refund or transfer online at https://
www.fda.gov/forindustry/userfees/
default.htm. This electronic submission
is intended to reduce the burden for
customers to submit a user fee payment
refund and transfer request.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 2
Number of
respondents
FDA Form No.
Number of
responses per
respondent
Total annual
responses
Average burden per
response
Total hours
User Fee Payment Refund Request—Form FDA
3913.
User Fee Payment Transfer Request—Form FDA
3914.
1,856
1
1,856
0.40 (24 minutes) ...........
742
86
1
86
0.25 (15 minutes) ..........
22
Total ................................................................
........................
..........................
........................
........................................
764
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
have been rounded.
2 Numbers
Our estimated burden for the
information collection reflects an
overall increase of 525 hours and a
corresponding increase of 1,274
responses. We attribute this adjustment
to an increase in the number of
submissions we received over the last
few years.
Dated: April 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–08968 Filed 4–25–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–N–1057]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Pregnancy
Exposure Registry Enrollment Project:
A Survey of Healthcare Providers To
Advance Pregnancy Safety Data
Collection and Improve Health
Communications
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
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 and
ddrumheller on DSK120RN23PROD with NOTICES1
SUMMARY:
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to allow 60 days for public comment in
response to the notice. This notice
solicits comments on a proposed study
entitled ‘‘Pregnancy Exposure Registry
Enrollment Project: A Survey of
Healthcare Providers To Advance
Pregnancy Safety Data Collection and
Improve Health Communications.’’
DATES: Either electronic or written
comments on the collection of
information must be submitted by June
25, 2024.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
June 25, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are received on or before
that date.
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
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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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2024–N–1057 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Pregnancy Exposure Registry
Enrollment Project: A Survey of
Healthcare Providers To Advance
Pregnancy Safety Data Collection and
Improve Health Communications.’’
Received comments, those filed in a
timely manner (see ADDRESSES), will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
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Federal Register / Vol. 89, No. 82 / Friday, April 26, 2024 / Notices
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
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 Dockets Management
Staff. 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.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.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, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Rachel Showalter, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 240–994–7399, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the
PRA (44 U.S.C. 3501–3521), 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
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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.
Pregnancy Exposure Registry
Enrollment Project: A Survey of
Healthcare Providers To Advance
Pregnancy Safety Data Collection and
Improve Health Communications
(OMB Control Number 0910—NEW)
I. Background
FDA has a need for data on pregnancy
exposure registries (registries). The goal
of the proposed Pregnancy Exposure
Registry Enrollment Project survey is to
determine healthcare providers’ (HCPs)
perceived barriers to sufficient patient
enrollment in pregnancy exposure
registries. FDA’s authority to conduct
research related to drugs and other FDAregulated products is set forth in the
Federal Food, Drug, and Cosmetic Act
(FD&C Act), (21 U.S.C. 393(d)(2)(C) and
(D)).
To ensure that pregnancy information
in product labeling is accurately
communicated to HCPs so that they can
make informed decisions about
treatment options for their patients,
human pregnancy safety data are
collected postapproval. Registries are an
important tool for pregnancy safety data
collection in the postmarketing setting.
Their prospective design and ability to
collect detailed patient information are
critical to obtain human data to inform
pregnancy labeling in a timely manner.
The pharmaceutical industry typically
sponsors registries often as a result of a
postmarketing requirement (PMR) or
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commitment (PMC) FDA issues at the
time of drug approval under section
505(o)(3) of the FD&C Act (21 U.S.C.
355(o)(3)). Under a PMR or PMC,
pharmaceutical industry sponsors often
work with private companies,
nonprofits, and/or academic health
centers to operate registries. Other
times, private companies, nonprofits,
Federal agencies other than FDA, or
academic health centers may develop
registries without FDA involvement to
facilitate pregnancy-related research
with other scientific goals. When
developing registry protocols, sponsors
and those who operate registries must
comply with 45 CFR part 46 and meet
the Criteria for IRB approval of research
under 45 CFR 46.111, which provides
protection of human research subjects,
subjects’ privacy, and the
confidentiality of subjects’ data.
Although registries are crucial to
understanding the safety and potential
toxicity of prescription products in the
perinatal population, many registries
fail to adequately enroll pregnant
individuals. HCPs are a trusted source
of information about health, and they
serve as gatekeepers for recruiting
pregnant individuals to enroll in
clinical studies such as registries. Thus,
HCPs are integral to the registry
enrollment process. Publications suggest
that low enrollment in registries may be
related to HCPs’ lack of awareness, time,
incentives, and comfort with discussing
clinical research with patients. Despite
this speculation about the barriers that
HCPs face, however, researchers have
not surveyed HCPs to understand their
challenges. FDA reviewed existing
literature and engaged with other
Offices and Centers within FDA and
external experts and determined that
this data collection is not duplicative.
During this voluntary, FDA-funded,
qualitative survey, we will recruit
through an existing panel of HCPs
currently licensed to practice in clinical
settings in the United States who
routinely care for or counsel pregnant
patients. We will engage three groups of
HCPs: (1) primary HCPs (obstetrician/
gynecologists, family practice
physicians, certified nurse-midwives,
physician assistants); (2) consulting
HCPs (neurologists, infectious disease
specialists, psychiatrists,
rheumatologists, cardiologists,
pulmonologists, dermatologists), and (3)
pharmacists. To be eligible for the
study, primary HCPs must routinely
care for or counsel five or more pregnant
patients per month, and consulting
HCPs and pharmacists must routinely
care for or counsel three or more
pregnant patients per month. All
eligible HCPs must have either a degree
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as a Doctor of Medicine, a Doctor of
Osteopathic Medicine, or a Doctor of
Pharmacy. Although we will recruit
with representativeness in mind, we
will weigh the data to ensure a
nationally representative sample of
HCPs. Generated tables will compare
the weighted distributions of the
variables used for weighting against
their corresponding benchmarks.
A contracted research firm will collect
data through internet administration.
One hundred percent (100%) of
participants will self-administer the
internet survey via a computer, which
will record responses and provide
appropriate probes when needed. We
will use automated technology in data
collection, data reduction, and analyses.
To identify eligible HCPs, we will send
a recruitment email that links to a
prequalifying screener on the internet.
The screener will include questions
about the HCP’s specialty, number of
years in practice, number of pregnant
patients counseled per month, and
demographics (age, race/ethnicity, and
gender) and will confirm that the
respondent does not work for FDA or a
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4. What barriers to patient enrollment
in pregnancy exposure registries are
identified by HCPs?
5. What ideas do HCPs have to
improve enrollment in pregnancy
exposure registries?
The target sample size for this study
is 400 completed surveys. The sample
will include an equal number of
primary HCPs, consulting HCPs, and
pharmacists. Such a design will help to
ensure assessment of not only HCPs’
perceptions generally, but also potential
variations between different types of
HCPs. HCPs are a difficult group to
recruit, so several strategies will be put
into place to achieve a high response
rate. These strategies include tailoring
contact materials, disclosing FDA
sponsorship on survey materials, and
providing a cash incentive.
To obtain 400 completed surveys, we
estimate that 2,000 experienced HCPs
will need to be screened. We estimate
that participation in the study will take
17 minutes.
FDA estimates the burden of this
collection of information as follows:
pharmaceutical company. We will
invite all respondents who meet
eligibility requirements to participate in
the survey within 24 hours of
completing the screener and obtain
informed consent from all survey
participants. The survey will assess
experienced HCPs’ knowledge of
registries, their attitudes toward them,
the barriers they face to recruiting
patients, and their ideas about
improving registry enrollment. Results
from this project will advance
pregnancy safety data collection from
registries and ultimately improve health
communications through inclusion of
human safety data in pregnancy
labeling. The survey is available on
request at pedsdrugs@fda.hhs.gov.
We have the following specific
research questions:
1. What proportion of HCPs know
about pregnancy exposure registries?
2. What proportion of HCPs have
referred patients to pregnancy exposure
registries?
3. What proportion of HCPs have
provided information from patient
medical records to pregnancy exposure
registries?
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
No. of
respondents
Activity
Total annual
responses
Average burden
per response
Total
hours
Screener .................................................................................
Main Study Survey .................................................................
2,000
400
1
1
2,000
400
0.0333 (2 minutes) ....
0.25 (15 minutes) ......
67
100
Total ................................................................................
2,000
........................
....................
....................................
167
1 There
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No. of
responses per
respondent
are no capital costs or operating and maintenance costs associated with this collection of information.
Prior to the main analysis, an outlier
analysis will be performed for the time
spent on any screen visited and total
time to complete the survey. Extreme
survey time will be identified and
appropriate adjustments will be made
prior to the final data analysis. The
extent of any missing information will
also be assessed to determine the data
quality. Descriptive statistics will afford
a look at the frequency of responses.
Assessment of potential differences
between primary HCPs, consulting
HCPs, and pharmacists can be
accomplished with pairwise
comparisons between groups. We will
also produce national-level estimates
about attitudes toward pregnancy
exposure registries and other key
questions.
An analysis of item nonresponse will
be made in the screener, if needed, and
in the main survey. Item nonresponse
rates will be tabulated for the
questionnaire items, allowing for skip
patterns. An analysis will be made of
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any questionnaire items that register
unusually high item nonresponse rates.
Multivariate item nonresponse
relationships will be evaluated,
including monotonicity patterns such as
breakoffs (all items dropped after a
particular item), and other types of
‘‘blocks’’ of multivariate item
nonresponse. High levels of item
nonresponse in particular items will
have their correlations with other
questionnaire item results in both the
screener and main survey analyzed
(tabulating how much the item
nonresponse is concentrating in a
particular subgroup of health providers).
The FDA anticipates disseminating
the results of the study after final
analyses of the data are completed,
reviewed, and cleared. The information
gathered on this topic will be used to
inform regulatory guidance to sponsors
and investigators designing pregnancy
exposure registry protocols.
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II. References
The following references are on
display at the Dockets Management Staff
(see ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they are also available
electronically at https://
www.regulations.gov. Although FDA
verified the website addresses in this
document, please note that websites are
subject to change over time.
1. Gelperin, K., H. Hammad, K. Leishear, et
al., ‘‘A Systematic Review of Pregnancy
Exposure Registries: Examination of
Protocol-Specified Pregnancy Outcomes,
Target Sample Size, and Comparator
Selection,’’ Pharmacoepidemiology and
Drug Safety, 2017 Feb;26(2):208–214.
doi: 10.1002/pds.4150. Epub 2016 Dec
27. PMID: 28028914.
2. FDA, ‘‘Postapproval Pregnancy Safety
Studies (May 2019).’’ Available at:
https://www.fda.gov/media/124746/
download.
3. National Institutes of Health, Task Force
on Research Specific to Pregnant Women
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and Lactating Women (PRGLAC).
Available at: https://www.nichd.nih.gov/
about/advisory/PRGLAC.
4. FDA, ‘‘Study Approaches and Methods To
Evaluate the Safety of Drugs and
Biological Products During Pregnancy in
the Post-Approval Setting,’’ May 28–29,
2014. Available at: https://www.fda.gov/
Drugs/NewsEvents/ucm386560.htm.
5. Daniels, J.L., D.A. Savitz, C. Bradley, et al.,
‘‘Attitudes Toward Participation in a
Pregnancy and Child Cohort Study,’’
Paediatric and Perinatal Epidemiology,
2006 May;20(3):260–266. doi: 10.1111/
j.1365–3016.2006.00720.x. PMID:
16629701.
6. Hartman, R.I. and A.B. Kimball,
‘‘Performing Research in Pregnancy:
Challenges and Perspectives,’’ Clinics in
Dermatology, 2016 May–Jun;34(3):410–
415. doi: 10.1016/
j.clindermatol.2016.02.014. Epub 2016
Feb 11. PMID: 27265080.
7. Krueger, W.S., M.S. Anthony, C.W. Saltus,
et al., ‘‘Evaluating the Safety of
Medication Exposures During Pregnancy:
A Case Study of Study Designs and Data
Sources in Multiple Sclerosis,’’ Drugs
Real World Outcomes, 2017
Sep;4(3):139–149. doi: 10.1007/s40801–
017–0114–9. PMID: 28756575; PMCID:
PMC5567459.
8. Sarker A., P. Chandrashekar, A. Magge, et
al., ‘‘Discovering Cohorts of Pregnant
Women From Social Media for Safety
Surveillance and Analysis,’’ Journal of
Medical internet Research, 2017 Oct
30;19(10):e361. doi: 10.2196/jmir.8164.
PMID: 29084707; PMCID: PMC5684515.
9. Sinclair S., M. Cunnington, J.
Messenheimer, et al., ‘‘Advantages and
Problems With Pregnancy Registries:
Observations and Surprises Throughout
the Life of the International Lamotrigine
Pregnancy Registry,’’
Pharmacoepidemiology and Drug Safety,
2014 Aug;23(8):779–786. doi: 10.1002/
pds.3659. Epub 2014 Jun 27. PMID:
24974947; PMCID: PMC4406353.
Dated: April 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–09028 Filed 4–25–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2024–D–1402]
Cancer Clinical Trial Eligibility Criteria:
Laboratory Values; Draft Guidance for
Industry, Institutional Review Boards,
and Clinical Investigators; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
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20:31 Apr 25, 2024
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announcing the availability of a draft
guidance for industry, institutional
review boards (IRBs), and clinical
investigators entitled ‘‘Cancer Clinical
Trial Eligibility Criteria: Laboratory
Values.’’ This draft guidance is one in
a series of guidances that provide
recommendations regarding eligibility
criteria for clinical trials of
investigational drugs regulated by the
Center for Drug Evaluation and Research
(CDER) and the Center for Biologics
Evaluation Research (CBER) for the
treatment of cancer. Specifically, this
draft guidance includes
recommendations for selecting
appropriate laboratory values as trial
eligibility criteria to avoid unjustified
exclusions of diverse trial participants.
DATES: Submit either electronic or
written comments on the draft guidance
by June 25, 2024 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time 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): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
PO 00000
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• For written/paper comments
submitted to the Dockets Management
Staff, 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–
2024–D–1402 for ‘‘Cancer Clinical Trial
Eligibility Criteria: Laboratory Values.’’
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
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
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 Dockets Management
Staff. 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.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.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, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
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]]>Agencies
[Federal Register Volume 89, Number 82 (Friday, April 26, 2024)]
[Notices]
[Pages 32447-32450]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09028]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-1057]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Pregnancy Exposure Registry Enrollment Project: A
Survey of Healthcare Providers To Advance Pregnancy Safety Data
Collection and Improve Health Communications
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. 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 and to
allow 60 days for public comment in response to the notice. This notice
solicits comments on a proposed study entitled ``Pregnancy Exposure
Registry Enrollment Project: A Survey of Healthcare Providers To
Advance Pregnancy Safety Data Collection and Improve Health
Communications.''
DATES: Either electronic or written comments on the collection of
information must be submitted by June 25, 2024.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 25, 2024. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are received on or before that date.
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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, 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-2024-N-1057 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Pregnancy Exposure Registry
Enrollment Project: A Survey of Healthcare Providers To Advance
Pregnancy Safety Data Collection and Improve Health Communications.''
Received comments, those filed in a timely manner (see ADDRESSES), will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the
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Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be 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 Dockets Management Staff. 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.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.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, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852, 240-994-7399,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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.
Pregnancy Exposure Registry Enrollment Project: A Survey of Healthcare
Providers To Advance Pregnancy Safety Data Collection and Improve
Health Communications
(OMB Control Number 0910--NEW)
I. Background
FDA has a need for data on pregnancy exposure registries
(registries). The goal of the proposed Pregnancy Exposure Registry
Enrollment Project survey is to determine healthcare providers' (HCPs)
perceived barriers to sufficient patient enrollment in pregnancy
exposure registries. FDA's authority to conduct research related to
drugs and other FDA-regulated products is set forth in the Federal
Food, Drug, and Cosmetic Act (FD&C Act), (21 U.S.C. 393(d)(2)(C) and
(D)).
To ensure that pregnancy information in product labeling is
accurately communicated to HCPs so that they can make informed
decisions about treatment options for their patients, human pregnancy
safety data are collected postapproval. Registries are an important
tool for pregnancy safety data collection in the postmarketing setting.
Their prospective design and ability to collect detailed patient
information are critical to obtain human data to inform pregnancy
labeling in a timely manner.
The pharmaceutical industry typically sponsors registries often as
a result of a postmarketing requirement (PMR) or commitment (PMC) FDA
issues at the time of drug approval under section 505(o)(3) of the FD&C
Act (21 U.S.C. 355(o)(3)). Under a PMR or PMC, pharmaceutical industry
sponsors often work with private companies, nonprofits, and/or academic
health centers to operate registries. Other times, private companies,
nonprofits, Federal agencies other than FDA, or academic health centers
may develop registries without FDA involvement to facilitate pregnancy-
related research with other scientific goals. When developing registry
protocols, sponsors and those who operate registries must comply with
45 CFR part 46 and meet the Criteria for IRB approval of research under
45 CFR 46.111, which provides protection of human research subjects,
subjects' privacy, and the confidentiality of subjects' data.
Although registries are crucial to understanding the safety and
potential toxicity of prescription products in the perinatal
population, many registries fail to adequately enroll pregnant
individuals. HCPs are a trusted source of information about health, and
they serve as gatekeepers for recruiting pregnant individuals to enroll
in clinical studies such as registries. Thus, HCPs are integral to the
registry enrollment process. Publications suggest that low enrollment
in registries may be related to HCPs' lack of awareness, time,
incentives, and comfort with discussing clinical research with
patients. Despite this speculation about the barriers that HCPs face,
however, researchers have not surveyed HCPs to understand their
challenges. FDA reviewed existing literature and engaged with other
Offices and Centers within FDA and external experts and determined that
this data collection is not duplicative.
During this voluntary, FDA-funded, qualitative survey, we will
recruit through an existing panel of HCPs currently licensed to
practice in clinical settings in the United States who routinely care
for or counsel pregnant patients. We will engage three groups of HCPs:
(1) primary HCPs (obstetrician/gynecologists, family practice
physicians, certified nurse-midwives, physician assistants); (2)
consulting HCPs (neurologists, infectious disease specialists,
psychiatrists, rheumatologists, cardiologists, pulmonologists,
dermatologists), and (3) pharmacists. To be eligible for the study,
primary HCPs must routinely care for or counsel five or more pregnant
patients per month, and consulting HCPs and pharmacists must routinely
care for or counsel three or more pregnant patients per month. All
eligible HCPs must have either a degree
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as a Doctor of Medicine, a Doctor of Osteopathic Medicine, or a Doctor
of Pharmacy. Although we will recruit with representativeness in mind,
we will weigh the data to ensure a nationally representative sample of
HCPs. Generated tables will compare the weighted distributions of the
variables used for weighting against their corresponding benchmarks.
A contracted research firm will collect data through internet
administration. One hundred percent (100%) of participants will self-
administer the internet survey via a computer, which will record
responses and provide appropriate probes when needed. We will use
automated technology in data collection, data reduction, and analyses.
To identify eligible HCPs, we will send a recruitment email that links
to a prequalifying screener on the internet. The screener will include
questions about the HCP's specialty, number of years in practice,
number of pregnant patients counseled per month, and demographics (age,
race/ethnicity, and gender) and will confirm that the respondent does
not work for FDA or a pharmaceutical company. We will invite all
respondents who meet eligibility requirements to participate in the
survey within 24 hours of completing the screener and obtain informed
consent from all survey participants. The survey will assess
experienced HCPs' knowledge of registries, their attitudes toward them,
the barriers they face to recruiting patients, and their ideas about
improving registry enrollment. Results from this project will advance
pregnancy safety data collection from registries and ultimately improve
health communications through inclusion of human safety data in
pregnancy labeling. The survey is available on request at
[email protected].
We have the following specific research questions:
1. What proportion of HCPs know about pregnancy exposure
registries?
2. What proportion of HCPs have referred patients to pregnancy
exposure registries?
3. What proportion of HCPs have provided information from patient
medical records to pregnancy exposure registries?
4. What barriers to patient enrollment in pregnancy exposure
registries are identified by HCPs?
5. What ideas do HCPs have to improve enrollment in pregnancy
exposure registries?
The target sample size for this study is 400 completed surveys. The
sample will include an equal number of primary HCPs, consulting HCPs,
and pharmacists. Such a design will help to ensure assessment of not
only HCPs' perceptions generally, but also potential variations between
different types of HCPs. HCPs are a difficult group to recruit, so
several strategies will be put into place to achieve a high response
rate. These strategies include tailoring contact materials, disclosing
FDA sponsorship on survey materials, and providing a cash incentive.
To obtain 400 completed surveys, we estimate that 2,000 experienced
HCPs will need to be screened. We estimate that participation in the
study will take 17 minutes.
FDA estimates the burden of this collection of information as
follows:
Table 1--estimated annual reporting burden \1\
----------------------------------------------------------------------------------------------------------------
No. of Total
Activity No. of responses per annual Average burden per Total
respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Screener..................... 2,000 1 2,000 0.0333 (2 minutes)......... 67
Main Study Survey............ 400 1 400 0.25 (15 minutes).......... 100
----------------------------------------------------------------------------------
Total.................... 2,000 .............. ........... ........................... 167
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Prior to the main analysis, an outlier analysis will be performed
for the time spent on any screen visited and total time to complete the
survey. Extreme survey time will be identified and appropriate
adjustments will be made prior to the final data analysis. The extent
of any missing information will also be assessed to determine the data
quality. Descriptive statistics will afford a look at the frequency of
responses. Assessment of potential differences between primary HCPs,
consulting HCPs, and pharmacists can be accomplished with pairwise
comparisons between groups. We will also produce national-level
estimates about attitudes toward pregnancy exposure registries and
other key questions.
An analysis of item nonresponse will be made in the screener, if
needed, and in the main survey. Item nonresponse rates will be
tabulated for the questionnaire items, allowing for skip patterns. An
analysis will be made of any questionnaire items that register
unusually high item nonresponse rates. Multivariate item nonresponse
relationships will be evaluated, including monotonicity patterns such
as breakoffs (all items dropped after a particular item), and other
types of ``blocks'' of multivariate item nonresponse. High levels of
item nonresponse in particular items will have their correlations with
other questionnaire item results in both the screener and main survey
analyzed (tabulating how much the item nonresponse is concentrating in
a particular subgroup of health providers).
The FDA anticipates disseminating the results of the study after
final analyses of the data are completed, reviewed, and cleared. The
information gathered on this topic will be used to inform regulatory
guidance to sponsors and investigators designing pregnancy exposure
registry protocols.
II. References
The following references are on display at the Dockets Management
Staff (see ADDRESSES) and are available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at https://www.regulations.gov. Although FDA
verified the website addresses in this document, please note that
websites are subject to change over time.
1. Gelperin, K., H. Hammad, K. Leishear, et al., ``A Systematic
Review of Pregnancy Exposure Registries: Examination of Protocol-
Specified Pregnancy Outcomes, Target Sample Size, and Comparator
Selection,'' Pharmacoepidemiology and Drug Safety, 2017
Feb;26(2):208-214. doi: 10.1002/pds.4150. Epub 2016 Dec 27. PMID:
28028914.
2. FDA, ``Postapproval Pregnancy Safety Studies (May 2019).''
Available at: https://www.fda.gov/media/124746/download.
3. National Institutes of Health, Task Force on Research Specific to
Pregnant Women
[[Page 32450]]
and Lactating Women (PRGLAC). Available at: https://www.nichd.nih.gov/about/advisory/PRGLAC.
4. FDA, ``Study Approaches and Methods To Evaluate the Safety of
Drugs and Biological Products During Pregnancy in the Post-Approval
Setting,'' May 28-29, 2014. Available at: https://www.fda.gov/Drugs/NewsEvents/ucm386560.htm.
5. Daniels, J.L., D.A. Savitz, C. Bradley, et al., ``Attitudes
Toward Participation in a Pregnancy and Child Cohort Study,''
Paediatric and Perinatal Epidemiology, 2006 May;20(3):260-266. doi:
10.1111/j.1365-3016.2006.00720.x. PMID: 16629701.
6. Hartman, R.I. and A.B. Kimball, ``Performing Research in
Pregnancy: Challenges and Perspectives,'' Clinics in Dermatology,
2016 May-Jun;34(3):410-415. doi: 10.1016/j.clindermatol.2016.02.014.
Epub 2016 Feb 11. PMID: 27265080.
7. Krueger, W.S., M.S. Anthony, C.W. Saltus, et al., ``Evaluating
the Safety of Medication Exposures During Pregnancy: A Case Study of
Study Designs and Data Sources in Multiple Sclerosis,'' Drugs Real
World Outcomes, 2017 Sep;4(3):139-149. doi: 10.1007/s40801-017-0114-
9. PMID: 28756575; PMCID: PMC5567459.
8. Sarker A., P. Chandrashekar, A. Magge, et al., ``Discovering
Cohorts of Pregnant Women From Social Media for Safety Surveillance
and Analysis,'' Journal of Medical internet Research, 2017 Oct
30;19(10):e361. doi: 10.2196/jmir.8164. PMID: 29084707; PMCID:
PMC5684515.
9. Sinclair S., M. Cunnington, J. Messenheimer, et al., ``Advantages
and Problems With Pregnancy Registries: Observations and Surprises
Throughout the Life of the International Lamotrigine Pregnancy
Registry,'' Pharmacoepidemiology and Drug Safety, 2014
Aug;23(8):779-786. doi: 10.1002/pds.3659. Epub 2014 Jun 27. PMID:
24974947; PMCID: PMC4406353.
Dated: April 23, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09028 Filed 4-25-24; 8:45 am]
BILLING CODE 4164-01-P
