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Federal Register / Vol. 86, No. 87 / Friday, May 7, 2021 / Notices
White Flint North, 10A12M, 11601
Landsdown St., North Bethesda, MD
20852, 3017968867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed collection of information to OMB for review and clearance.
Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms21 CFR 884.5300 OMB
Control Number 09100633Extension Under the Medical Device Amendments of 1976 Pub. L. 94295, class II devices were defined as those devices for which there was insufficient information to show that general controls themselves would provide a reasonable assurance of safety and effectiveness but for which there was sufficient information to establish performance standards to provide such assurance. Accordingly, FDA has established the above captioned special controls guidance document regarding the labeling of natural rubber latex condoms.
Condoms without spermicidal lubricant containing nonoxynol 9 are classified in class II. They were originally classified before the enactment of provisions of the Safe Medical Devices Act of 1990 Pub. L.

101629, which broadened the definition of class II devices and now permits FDA to establish special controls beyond performance standards, including guidance documents, to help provide reasonable assurance of the safety and effectiveness of such devices.
In December 2000, Congress enacted Public Law 106554, which directed FDA to reexamine existing condom labels and determine whether the labels are medically accurate regarding the overall effectiveness or lack of effectiveness in preventing sexually transmitted diseases . . . In response, FDA recommended labeling intended to provide important information for condom users, including the extent of protection provided by condoms against various types of sexually transmitted diseases.
Respondents to this collection of information are manufacturers and repackagers of male condoms made of natural rubber latex without spermicidal lubricant. FDA expects approximately five new manufacturers or repackagers to enter the market yearly and to collectively have a third-party disclosure burden of 60 hours. Our assumption of the burden per disclosure is based on our history with the information collection. Because the packaging requirements for condoms are similar to those of many over-the-

counter 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 previously approved collections of information found in FDA regulations. The collections of information in 21 CFR
part 801 have been approved under OMB control number 09100485; the collections of information in 21 CFR
part 807, subpart E have been approved under OMB control number 09100120;
and the collections of information in 21
CFR part 820 have been approved under OMB control number 09100073.
The collection of information under 21 CFR 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 1320.3c2.
In the Federal Register of January 4, 2021 86 FR 109, FDA published a 60day notice requesting public comment on the proposed collection of information. No comments were received.
FDA estimates the burden of this collection of information as follows:

TABLE 1ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Activity
Number of respondents
Number of disclosures per respondent
Total annual disclosures
Average burden per disclosure
Total hours
Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms Classified Under 21
CFR 884.5300

5

1

5

12

60

1 There
are no capital costs or operating and maintenance costs associated with this collection of information.

Based on a review of the information collection since our last request for OMB approval, we have made no adjustments to our burden estimate.

DEPARTMENT OF HEALTH AND
HUMAN SERVICES

Dated: May 3, 2021.
Lauren K. Roth, Acting Principal Associate Commissioner for Policy.

National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
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National Institutes of Health
Pursuant to section 10d of the Federal Advisory Committee Act, as amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552bc4 and 552bc6, Title 5 U.S.C., as amended. The contract proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable material,
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and personal information concerning individuals associated with the contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: National Institute of Allergy and Infectious Diseases Special Emphasis Panel; Small Business Innovation Research SBIR Phase II Program Contract Solicitation PHS 20181 QrumPharma Topic 051: Inhaled Delivery of Clofazimine CFZ.
Date: May 28, 2021.
Time: 10:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate contract proposals.
Place: National Institute of Allergy and Infectious Diseases, National Institutes of Health, 5601 Fishers Lane, Room 3G31, Rockville, MD 20892 Virtual Meeting.
Contact Person: Cynthia L. De La Fuente, Ph.D., Scientific Review Officer, Scientific
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