Notice2024-09028
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
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
April 26, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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."
Full Text
<html>
<head>
<title>Federal Register, Volume 89 Issue 82 (Friday, April 26, 2024)</title>
</head>
<body><pre>
[Federal Register Volume 89, Number 82 (Friday, April 26, 2024)]
[Notices]
[Pages 32447-32450]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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.
-----------------------------------------------------------------------
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the
[[Page 32448]]
Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#c090928193b4a1a6a680a6a4a1eea8a8b3eea7afb6"><span class="__cf_email__" data-cfemail="8fdfddcedcfbeee9e9cfe9ebeea1e7e7fca1e8e0f9">[email protected]</span></a>.
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
[[Page 32449]]
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
<a href="/cdn-cgi/l/email-protection#15657071667167607266557371743b7d7d663b727a63"><span class="__cf_email__" data-cfemail="64140100170016110317240200054a0c0c174a030b12">[email protected]</span></a>.
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. 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: <a href="https://www.fda.gov/media/124746/download">https://www.fda.gov/media/124746/download</a>.
3. National Institutes of Health, Task Force on Research Specific to
Pregnant Women
[[Page 32450]]
and Lactating Women (PRGLAC). Available at: <a href="https://www.nichd.nih.gov/about/advisory/PRGLAC">https://www.nichd.nih.gov/about/advisory/PRGLAC</a>.
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: <a href="https://www.fda.gov/Drugs/NewsEvents/ucm386560.htm">https://www.fda.gov/Drugs/NewsEvents/ucm386560.htm</a>.
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
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on April 26, 2024.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.