0633_Supporting Statement_2021

0633_Supporting Statement_2021.pdf

Guidance on Labeling for Natural Rubber Latex Condoms

OMB: 0910-0633

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U.S. Food and Drug Administration
Guidance on Labeling for Natural Rubber Latex Condoms
OMB Control No. 0910-0633
Terms of Clearance: None.
1. Circumstances Making the Collection of Information Necessary
This information collection supports Food and Drug Administration (FDA) regulations
and accompanying guidance. The Federal Food, Drug, and Cosmetic Act (FD&C Act)
(21 U.S.C. 301), established a comprehensive system for the regulation of medical
devices intended for human use. Section 513 of the FD&C Act (21 U.S.C. 360c)
established three categories (classes) of devices, defined by the regulatory controls
needed to provide reasonable assurance of their safety and effectiveness. The three
categories of devices are class I (general controls), class II (special controls), and class III
(premarket approval).
Class II devices are defined as devices for which there was insufficient information to
show that general controls themselves would provide reasonable assurance of safety and
effectiveness, but for which there was sufficient information to establish performance
standards to provide such assurance. The natural rubber latex condoms without
spermicidal lubricant are class II devices. Section 513(a)(1)(B) of the FD&C Act defines
those devices for which the general controls by themselves are insufficient to provide
reasonable assurance of safety and effectiveness, but for which there is sufficient
information to establish special controls to provide such assurance, including
performance standards, postmarket surveillance, patient registries, dissemination and
development of guidelines, recommendations, and any other appropriate actions the
Agency deems necessary. FDA selected a special controls guidance document as the
most effective method for disseminating its labeling recommendations for condoms
without spermicidal lubricant.
On December 21, 2000, Congress enacted Public Law 106-554,
https://www.congress.gov/106/plaws/publ554/PLAW-106publ554.pdf, which required
that FDA “* * * reexamine existing condom labels” and “* * * determine whether the
labels are medically accurate regarding the overall effectiveness or lack of effectiveness
of condoms in preventing sexually transmitted diseases, including [human
papillomavirus].” Under this mandate, FDA undertook a review of the medical accuracy
of condom labeling, which included an extensive review of the scientific information
related to condoms. The special controls guidance document includes labeling
recommendations based on this FDA review.
We therefore request OMB approval of the information collection provisions discussed in
the guidance document and this supporting statement.


2. Purpose and Use of the Information Collection
The primary users of the information disclosed on the label or in the labeling for devices are
the health professionals who use or prescribe the device or the lay consumers who use
the device. The intent of these rules is that the labeling should contain sufficient
information for these persons to use the device safely and effectively. FDA may use
the information to determine whether there is reasonable assurance of the safety and
effectiveness of the device for its intended use. Failure of the manufacturer, packer, or
distributor to label its products in accordance with section 502 of the FD&C Act may result
in the product being misbranded under the FD&C Act and the firm and the product
subject to regulatory action.
3. Use of Improved Information Technology and Burden Reduction
Manufacturers and repackagers may use any appropriate forms of information technology
to develop and distribute the recommended labeling.
4. Efforts to Identify Duplication and Use of Similar Information
FDA is the only agency with jurisdiction that can recommend labeling changes to
medical devices, which includes male condoms made of natural rubber latex. We are
unaware of duplicative information collection.
5. Impact on Small Businesses or Other Small Entities
Using the guidelines set by the Small Business Administration on what constitutes a
small business (for manufacturing, a small business cannot exceed 500 employees), we
estimate that approximately 95% of U.S. medical device manufacturing establishments
are considered small businesses.
FDA aids small business and manufacturers by providing guidance and information
through the Center for Devices and Radiological Health’s Division of Industry and
Consumer Education (DICE). DICE provides workshops, onsite evaluations and other
technical and nonfinancial assistance to small manufacturers. DICE also maintains a tollfree 800 telephone number and a website that firms may use to obtain regulatory
compliance information.
6. Consequences of Collecting the Information Less Frequently
This is a one-time burden for respondents, because once a label is redesigned, it can be
used indefinitely.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for this collection of information.


8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
In accordance with 5 CFR 1320.8(d), FDA published a 60 day notice for public comment
in the Federal Register of January 4, 2021 (86 FR 109). No comments were received in
response to the notice.
9. Explanation of Any Payment or Gift to Respondents
There are no incentives, payments, or gifts associated with this information collection.
10. Assurance of Confidentiality Provided to Respondents
In preparing this Supporting Statement, we consulted our Privacy Office to ensure
appropriate identification and handling of information collected.
This ICR does not collect personally identifiable information (PII). This ICR is a
labeling requirement with no submissions or PII collected.
Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), the public has broad
access to government documents. However, FOIA provides certain exemptions from
mandatory public disclosure of government records (5 U.S.C. 552(b)(1-9)). FDA will
make the fullest possible disclosure of records to the public, consistent with the rights of
individuals to privacy, the property rights of persons in trade and confidential commercial
or financial information.
11. Justification for Sensitive Questions
The collection of information does not involve sensitive questions.
12. Estimates of Annualized Burden Hours and Costs
12a. Annualized Hour Burden Estimate
FDA estimates the burden of this collection as follows:
Table 1.--Estimated Annual Third-Party Disclosure Burden
No. of
No. of
Respondents Disclosures per
“Class II Special Controls Guidance
Document: Labeling for Natural Rubber
Latex Condoms Classified Under 21
CFR 884.5300”

Burden per


FDA expects approximately five new manufacturers or repackagers to enter the market
yearly, and collectively have a third-party disclosure burden of 60 hours. The average
burden per disclosure was derived from a study performed for FDA by Eastern Research

Group, Inc., an economic consulting firm, to estimate the impact of the 1999 over-thecounter (OTC) human drug labeling requirements final rule (64 FR 13254, March 17,
1999). Because the packaging requirements for condoms are similar to those of many
OTC drugs, we believe the burden to design the labeling for OTC drugs is an appropriate
proxy for the estimated burden to design condom labeling.
The special controls guidance document also refers to currently approved collections of
information found in FDA regulations. The collections of information under 21 CFR part
807, subpart E, have been approved under OMB control number 0910-0120; the
collections of information under 21 CFR part 820 have been approved under OMB
control number 0910-0073; and the collections of information in 21 CFR part 801 have
been approved under OMB control number 0910-0485.
The collection of information in 21 CFR part 801.437 does not constitute a “collection of
information” under the PRA. Rather it is a “public disclosure of information originally
supplied by the Federal government to the recipient for the purpose of disclosure to the
public” (5 CFR 1320.3(c)(2)).
12b. Annualized Cost Burden Estimate
Total Burden

Label designers

Hourly Wage Rate



Total Respondent


We estimate the annual cost burden to be approximately $3,600. This is based on the
estimated total annual burden hours and the May 2019 Bureau of Labor Statistics
(https://www.bls.gov/oes/current/naics4_339100.htm#27-0000) median hourly wage of
$29.89 for the profession of ‘Designer’ (occupation code 27-1020, ), in the ‘Medical
Equipment and Supplies Manufacturing’ industry (NAICS code 339100). The wage rate
was then doubled to account for benefits and overhead, and rounded to the nearest dollar.
13. Estimates of Other Total Annual Costs to Respondents and/or Recordkeepers/Capital
There are no capital, start-up, operating or maintenance costs associated with this
information collection.
14. Annualized Cost to the Federal Government
Because FDA’s review of this information is conducted as part of the Premarket
Notification (510(k)) process, the annualized cost for FDA to review the labels or any
other action on the labels is included in, and approved under, OMB control number 09100120.


15. Explanation for Program Changes or Adjustments
This is a request for extension without change to the burden hour estimate. There are no
adjustments or program changes.
16. Plans for Tabulation and Publication and Project Time Schedule
This information collection will not be published or tabulated.
17. Reason(s) Display of OMB Expiration Date is Inappropriate
FDA will display the OMB expiration date as required by 5 CFR 1320.5.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.


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