Agency Information Collection Activities; Proposed Collection; Comment Request; Class II Special Controls Guidance Document: Labeling Natural Rubber Latex Condoms
Federal Register, Volume 82 Issue 216 (Thursday, November 9, 2017)
Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)
Notices
Pages 52056-52058
From the Federal Register Online via the Government Publishing Office www.gpo.gov
FR Doc No: 2017-24415
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Docket No. FDA-2014-N-1414
Agency Information Collection Activities; Proposed Collection; Comment Request; Class II Special Controls Guidance Document: Labeling Natural Rubber Latex Condoms
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
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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, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection for the labeling of natural rubber latex condoms.
DATES: Submit either electronic or written comments on the collection of information by January 8, 2018.
ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before January 8, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of January 8, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is 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-2014-N-1414 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms.'' 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 Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
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.gpo.gov/fdsys/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.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: 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. ``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, including each proposed extension of an existing 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.
Class II Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms--21 CFR 884.5300; OMB Control Number 0910-0633--
Extension
Under the Medical Device Amendments of 1976 (Pub. L. 94-295), 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
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effectiveness but for which there was sufficient information to establish performance standards to provide such assurance.
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. 101-629), which broadened the definition of class II devices and now permit 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 106-554, 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. The number of respondents cited in table 1 is based on FDA's database of premarket submissions and the electronic registration and listing database. 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-the-counter (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 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 0910-0485; the collections of information in 21 CFR part 807 subpart E have been approved under OMB control number 0910-
0120; and the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073.
The collection of information under 21 CFR 801.437 does not constitute a ``collection of information'' under the Paperwork Reduction Act of 1995. 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)).
FDA estimates the burden of this collection of information as follows:
Table 1--Estimated Annual Third-Party Disclosure Burden \1\
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Number of
Activity Number of disclosures per Total annual Average burden Total hours
respondents respondent disclosures per disclosure
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Class II Special Controls Guidance Document: Labeling for Natural 5 1 5 12 60
Rubber Latex Condoms Classified Under 21 CFR 884.5300.............
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
The estimated burden of this information collection has not changed since the last OMB approval.
Dated: November 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
FR Doc. 2017-24415 Filed 11-8-17; 8:45 am
BILLING CODE 4164-01-P
