82 FR 52056 - Agency Information Collection Activities; Proposed Collection; Comment Request; Class II Special Controls Guidance Document: Labeling Natural Rubber Latex Condoms
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 216 (November 9, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 216 (November 9, 2017)
| Page Range | 52056-52058 | |
| FR Document | 2017-24415 |
[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)] [Notices] [Pages 52056-52058] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-24415] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of [[Page 52057]] 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.thefederalregister.org/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, [email protected]. 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 [[Page 52058]] 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\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of disclosures per Total annual Average burden Total hours respondents respondent disclosures per disclosure -------------------------------------------------------------------------------------------------------------------------------------------------------- Class II Special Controls Guidance Document: Labeling for Natural 5 1 5 12 60 Rubber Latex Condoms Classified Under 21 CFR 884.5300............. -------------------------------------------------------------------------------------------------------------------------------------------------------- \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
![52056 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of Average
Number of responses Total annual
21 CFR section/activity burden per Total hours
respondents per responses response
respondent
Total 2 ............................................................................ ........................ ........................ ........................ ........................ 12,729
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
2 No burden has been estimated for the recordkeeping requirement in § 107.280 because these records are maintained as a usual and cus-
tomary part of normal business activities. Manufacturers keep infant formula distribution records for the prescribed period as a matter of routine
business practice.
The reporting and third-party on FDA’s experience and information to carry out additional effectiveness
disclosure burden estimates are based from firms that have conducted recalls. checks and issue additional
on FDA’s records, which show that FDA estimates that two respondents notifications, for a total of 625 hours.
there are six manufacturers of infant will conduct infant formula recalls Under 5 CFR 1320.3(b)(2), the time,
formula and that there have been, on under § 107.230 and that it will take a effort, and financial resources necessary
average, two infant formula recalls per respondent 4,450 hours to comply with
to comply with a collection of
year for the past 3 years. Based on this the requirements of that section, for a
information are excluded from the
information, FDA estimates that there total of 8,900 hours. FDA estimates that
will be, on average, approximately two two respondents will conduct infant burden estimate if the reporting,
infant formula recalls per year over the formula recalls under § 107.240 and that recordkeeping, or disclosure activities
next 3 years. it will take a respondent 1,482 hours to needed to comply are usual and
Thus, FDA estimates that two comply with the requirements of that customary because they would occur in
respondents will conduct recalls section, for a total of 2,964 hours. FDA the normal course of activities. No
annually under §§ 107.230, 107.240, and estimates that two respondents will burden has been estimated for the
107.250. The estimated number of submit recommendations for recordkeeping requirement in § 107.280
respondents for § 107.260 is minimal termination of infant formula recalls because these records are maintained as
because FDA seldom uses this section; under § 107.250 and that it will take a a usual and customary part of normal
therefore, FDA estimates that there will respondent 120 hours to comply with business activities. Manufacturers keep
be one or fewer respondents annually the requirements of that section, for a infant formula distribution records for
for § 107.260. The estimated number of total of 240 hours. Finally, FDA the prescribed period as a matter of
hours per response is an average based estimates that one respondent will need routine business practice.
TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of responses Total annual
21 CFR section/activity burden per Total hours
respondents per responses response
respondent
107.230; Elements of an infant formula recall ..................... 2 1 2 50 100
107.260; Revision of an infant formula recall ...................... 1 1 1 25 25
Total 2 ............................................................................ ........................ ........................ ........................ ........................ 125
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Table 2 reports FDA’s third-party § 107.260 is the requirement to issue DEPARTMENT OF HEALTH AND
disclosure burden estimates for additional notifications where the recall HUMAN SERVICES
§§ 107.230 and 107.260. The estimated strategy or implementation is
burden hours per disclosure is an determined to be deficient. FDA Food and Drug Administration
average based on FDA’s experience. The estimates that one respondent will issue
third-party disclosure burden in [Docket No. FDA–2014–N–1414]
additional notifications under § 107.260
§ 107.230 is the requirement to and that it will take a respondent 25 Agency Information Collection
promptly notify each affected direct hours to comply with the third-party Activities; Proposed Collection;
account (customer) about the recall, and disclosure requirements of that section, Comment Request; Class II Special
if the recalled formula presents a risk to for a total of 25 hours. Controls Guidance Document:
human health, the recalling firm must
Dated: November 6, 2017. Labeling Natural Rubber Latex
also request that each establishment that
Condoms
sells the recalled formula post a notice Anna K. Abram,
of the recall at the point of purchase.
sradovich on DSK3GMQ082PROD with NOTICES
Deputy Commissioner for Policy, Planning, AGENCY: Food and Drug Administration,
FDA estimates that two respondents Legislation, and Analysis. HHS.
will conduct infant formula recalls [FR Doc. 2017–24410 Filed 11–8–17; 8:45 am] ACTION: Notice.
under § 107.230 and that it will take a BILLING CODE 4164–01–P
respondent 50 hours to comply with the SUMMARY: The Food and Drug
third-party disclosure requirements of Administration (FDA or Agency) is
that section, for a total of 100 hours. The announcing an opportunity for public
third-party disclosure burden in comment on the proposed collection of
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![52058 Federal Register / Vol. 82, No. 216 / Thursday, November 9, 2017 / Notices
effectiveness but for which there was protection provided by condoms against the estimated burden to design condom
sufficient information to establish various types of sexually transmitted labeling.
performance standards to provide such diseases. The special controls guidance
assurance. Respondents to this collection of
document also refers to previously
Condoms without spermicidal information are manufacturers and
lubricant containing nonoxynol 9 are repackagers of male condoms made of approved collections of information
classified in class II. They were natural rubber latex without spermicidal found in FDA regulations. The
originally classified before the lubricant. FDA expects approximately collections of information in 21 CFR
enactment of provisions of the Safe five new manufacturers or repackagers part 801 have been approved under
Medical Devices Act of 1990 (Pub. L. to enter the market yearly and to OMB control number 0910–0485; the
101–629), which broadened the collectively have a third-party collections of information in 21 CFR
definition of class II devices and now disclosure burden of 60 hours. The part 807 subpart E have been approved
permit FDA to establish special controls number of respondents cited in table 1 under OMB control number 0910–0120;
beyond performance standards, is based on FDA’s database of premarket and the collections of information in 21
including guidance documents, to help submissions and the electronic CFR part 820 have been approved under
provide reasonable assurance of the registration and listing database. The OMB control number 0910–0073.
safety and effectiveness of such devices. average burden per disclosure was The collection of information under
In December 2000, Congress enacted derived from a study performed for FDA 21 CFR 801.437 does not constitute a
Public Law 106–554, which directed by Eastern Research Group, Inc., an ‘‘collection of information’’ under the
FDA to ‘‘reexamine existing condom economic consulting firm, to estimate Paperwork Reduction Act of 1995.
labels’’ and ‘‘determine whether the the impact of the 1999 over-the-counter
Rather, it is a ‘‘public disclosure of
labels are medically accurate regarding (OTC) human drug labeling
the overall effectiveness or lack of information originally supplied by the
requirements final rule (64 FR 13254,
effectiveness in preventing sexually Federal Government to the recipient for
March 17, 1999). Because the packaging
transmitted diseases. . . .’’ In response, requirements for condoms are similar to the purpose of disclosure to the public’’
FDA recommended labeling intended to those of many OTC drugs, we believe (5 CFR 1320.3(c)(2)).
provide important information for the burden to design the labeling for FDA estimates the burden of this
condom users, including the extent of OTC drugs is an appropriate proxy for collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Average
Number of disclosures Total annual
Activity burden per Total hours
respondents per disclosures disclosure
respondent
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.
The estimated burden of this announcing the availability of a draft • Federal eRulemaking Portal:
information collection has not changed guidance for industry entitled ‘‘Use of a https://www.regulations.gov. Follow the
since the last OMB approval. Drug Master File for Shared System instructions for submitting comments.
Dated: November 6, 2017. REMS Submissions.’’ The draft Comments submitted electronically,
Anna K. Abram, guidance provides information to including attachments, to https://
applicants who are part of a shared www.regulations.gov will be posted to
Deputy Commissioner for Policy, Planning,
Legislation, and Analysis. system Risk Evaluation and Mitigation the docket unchanged. Because your
Strategy (REMS) on using an electronic comment will be made public, you are
[FR Doc. 2017–24415 Filed 11–8–17; 8:45 am]
Type V Drug Master File (DMF). FDA solely responsible for ensuring that your
BILLING CODE 4164–01–P
recommends that applicants who are comment does not include any
part of a shared system REMS use a confidential information that you or a
Type V DMF for their REMS third party may not wish to be posted,
DEPARTMENT OF HEALTH AND
submissions to improve the efficiency of such as medical information, your or
HUMAN SERVICES
the submission and review process. anyone else’s Social Security number, or
Food and Drug Administration confidential business information, such
DATES: Submit either electronic or as a manufacturing process. Please note
[Docket No. FDA–2017–D–6231] written comments on the draft guidance that if you include your name, contact
by January 8, 2018 to ensure that the information, or other information that
Use of a Drug Master File for Shared Agency considers your comment on this identifies you in the body of your
System Risk Evaluation and Mitigation draft guidance before it begins work on comments, that information will be
Strategy Submissions; Draft Guidance
sradovich on DSK3GMQ082PROD with NOTICES
the final version of the guidance. posted on https://www.regulations.gov.
for Industry; Availability • If you want to submit a comment
ADDRESSES: You may submit comments with confidential information that you
AGENCY: Food and Drug Administration,
on any guidance at any time as follows: do not wish to be made available to the
HHS.
ACTION: Notice of availability. Electronic Submissions public, submit the comment as a
written/paper submission and in the
SUMMARY: The Food and Drug Submit electronic comments in the manner detailed (see ‘‘Written/Paper
Administration (FDA or Agency) is following way: Submissions’’ and ‘‘Instructions’’).
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Document Created: 2018-10-25 10:29:21
Document Modified: 2018-10-25 10:29:21
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Submit either electronic or written comments on the collection of information by January 8, 2018. | |
| 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, [email protected] | |
| FR Citation | 82 FR 52056 |
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