82 FR 60207 - Agency Information Collection Activities; Proposed Collection; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 242 (December 19, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 242 (December 19, 2017)
| Page Range | 60207-60209 | |
| FR Document | 2017-27276 |
[Federal Register Volume 82, Number 242 (Tuesday, December 19, 2017)] [Notices] [Pages 60207-60209] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27276] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2011-N-0672] Agency Information Collection Activities; Proposed Collection; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices 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, 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 reprocessed, single-use device labeling. DATES: Submit either electronic or written comments on the collection of information by February 20, 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 February 20, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of February 20, 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-2011-N-0672 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices.'' 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 [[Page 60208]] 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. Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices OMB Control Number 0910-0577--Extension Section 502 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 352), among other things, establishes requirements that the label or labeling of a medical device must meet so that it is not misbranded and subject to regulatory action. Section 301 of the Medical Device User Fee and Modernization Act of 2002 (Pub. L. 107-250) amended section 502 of the FD&C Act to add section 502(u) to require devices (both new and reprocessed) to bear prominently and conspicuously the name of the manufacturer, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying the manufacturer. Section 2(c) of the Medical Device User Fee Stabilization Act of 2005 (Pub. L. 109-43) amends section 502(u) of the FD&C Act by limiting the provision to reprocessed single-use devices (SUDs) and the manufacturers who reprocess them. Under the amended provision, if the original SUD or an attachment to it prominently and conspicuously bears the name of the manufacturer, then the reprocessor of the SUD is required to identify itself by name, abbreviation, or symbol in a prominent and conspicuous manner on the device or attachment to the device. If the original SUD does not prominently and conspicuously bear the name of the manufacturer, the manufacturer who reprocesses the SUD for reuse may identify itself using a detachable label that is intended to be affixed to the patient record. The requirements of section 502(u) of the FD&C Act impose a minimal burden on industry. This section of the FD&C Act only requires the manufacturer, packer, or distributor of a device to include their name and address on the labeling of a device. This information is readily available to the establishment and easily supplied. From its registration and premarket submission database, FDA estimates that there are 67 establishments that distribute approximately 427 reprocessed SUDs. Each response is anticipated to take 0.1 hours (6 minutes) resulting in a total burden to industry of 43 hours. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Third-Party Disclosure Burden 1 2 -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Type of respondent Number of disclosures Total annual Average burden per disclosure Total hours respondents per respondent disclosures -------------------------------------------------------------------------------------------------------------------------------------------------------- Establishments listing fewer than 10 SUDs..... 58 2 116 0.1 (6 minutes)......................... 12 Establishments listing 10 or more SUDs........ 9 34 306 0.1 (6 minutes)......................... 31 --------------------------------------------------------------------------------------------------------- Total..................................... .............. .............. .............. ........................................ 43 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ Numbers have been rounded. [[Page 60209]] The burden for this information collection has not changed since the last OMB approval. Dated: December 14, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-27276 Filed 12-18-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 242 / Tuesday, December 19, 2017 / Notices 60207
person seeking an order under section Dated: December 13, 2017. solely responsible for ensuring that your
911(g)(1) of the FD&C Act must show Leslie Kux, comment does not include any
that the tobacco product, as it is actually Associate Commissioner for Policy. confidential information that you or a
used by consumers, will significantly [FR Doc. 2017–27246 Filed 12–18–17; 8:45 am] third party may not wish to be posted,
reduce harm and the risk of tobacco- BILLING CODE 4164–01–P such as medical information, your or
related disease to individual tobacco anyone else’s Social Security number, or
users and will benefit the health of the confidential business information, such
population as a whole taking into DEPARTMENT OF HEALTH AND as a manufacturing process. Please note
account both users of tobacco products HUMAN SERVICES that if you include your name, contact
and persons who do not currently use information, or other information that
Food and Drug Administration identifies you in the body of your
tobacco products. Section 911(g)(4) of
the FD&C Act describes factors that FDA [Docket No. FDA–2011–N–0672] comments, that information will be
posted on https://www.regulations.gov.
must take into account in evaluating • If you want to submit a comment
whether a tobacco product benefits the Agency Information Collection
Activities; Proposed Collection; with confidential information that you
health of individuals and the population do not wish to be made available to the
as a whole. Comment Request; Prominent and
Conspicuous Mark of Manufacturers public, submit the comment as a
FDA is issuing this notice to inform on Single-Use Devices written/paper submission and in the
the public that the MRTPAs for the manner detailed (see ‘‘Written/Paper
following products submitted by R.J. AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’).
Reynolds Tobacco Co. have been filed HHS.
ACTION: Notice. Written/Paper Submissions
and are being made available for public
comment: Submit written/paper submissions as
SUMMARY: The Food and Drug follows:
• MR0000068: Camel Snus Frost Administration (FDA or Agency) is • Mail/Hand delivery/Courier (for
• MR0000069: Camel Snus Frost Large announcing an opportunity for public written/paper submissions): Dockets
comment on the proposed collection of Management Staff (HFA–305), Food and
• MR0000070: Camel Snus Mellow certain information by the Agency. Drug Administration, 5630 Fishers
• MR0000071: Camel Snus Mint Under the Paperwork Reduction Act of Lane, Rm. 1061, Rockville, MD 20852.
• MR0000072: Camel Snus Robust 1995 (PRA), Federal Agencies are • For written/paper comments
required to publish notice in the submitted to the Dockets Management
• MR0000073: Camel Snus Winterchill Federal Register concerning each Staff, FDA will post your comment, as
In this document, FDA is announcing proposed collection of information, well as any attachments, except for
the availability of the applications for including each proposed extension of an information submitted, marked and
public comment. FDA will make any existing collection of information, and identified, as confidential, if submitted
amendments submitted by the applicant to allow 60 days for public comment in as detailed in ‘‘Instructions.’’
available for public comment on a response to the notice. This notice Instructions: All submissions received
rolling basis. The applications will be solicits comments on reprocessed, must include the Docket No. FDA–
available for public comment for 180 single-use device labeling. 2011–N–0672 for ‘‘Agency Information
days from the date this notice is DATES: Submit either electronic or Collection Activities; Proposed
published; however, in the event that written comments on the collection of Collection; Comment Request;
fewer than 30 days remain in the 180- information by February 20, 2018. Prominent and Conspicuous Mark of
day comment period when an ADDRESSES: You may submit comments Manufacturers on Single-Use Devices.’’
amendment is posted, FDA will extend as follows. Please note that late, Received comments, those filed in a
or reopen the comment period to allow untimely filed comments will not be timely manner (see ADDRESSES), will be
for at least 30 days of public comment considered. Electronic comments must placed in the docket and, except for
on the amendment. FDA believes that be submitted on or before February 20, those submitted as ‘‘Confidential
this comment period is appropriate 2018. The https://www.regulations.gov Submissions,’’ publicly viewable at
given the volume and complexity of the electronic filing system will accept https://www.regulations.gov or at the
applications being posted. FDA will comments until midnight Eastern Time Dockets Management Staff between 9
notify the public about the availability at the end of February 20, 2018. a.m. and 4 p.m., Monday through
of amendments to these applications Comments received by mail/hand Friday.
delivery/courier (for written/paper • Confidential Submissions—To
and changes to related comment periods
submissions) will be considered timely submit a comment with confidential
via the Agency’s website and other
if they are postmarked or the delivery information that you do not wish to be
means of public communication. To
service acceptance receipt is on or made publicly available, submit your
encourage public participation
before that date. comments only as a written/paper
consistent with section 911(e) of the
submission. You should submit two
FD&C Act, FDA is making the redacted Electronic Submissions copies total. One copy will include the
MRTPAs that are the subject of this information you claim to be confidential
Submit electronic comments in the
notice available electronically (see with a heading or cover note that states
following way:
section II). • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
sradovich on DSK3GMQ082PROD with NOTICES
II. Electronic Access https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
instructions for submitting comments. Agency will review this copy, including
Persons with access to the internet Comments submitted electronically, the claimed confidential information, in
may obtain the documents at: https:// including attachments, to https:// its consideration of comments. The
www.fda.gov/TobaccoProducts/ www.regulations.gov will be posted to second copy, which will have the
Labeling/MarketingandAdvertising/ the docket unchanged. Because your claimed confidential information
UCM564399.htm. comment will be made public, you are redacted/blacked out, will be available
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The burden for this information 0990–New–30D and project title for provide guidance on the development
collection has not changed since the last reference. and implementation of their
OMB approval. SUPPLEMENTARY INFORMATION: Interested communication and education efforts.
Dated: December 14, 2017. persons are invited to send comments The information collected will be used
Leslie Kux, regarding this burden estimate or any to improve communication, products,
other aspect of this collection of and services that support key office
Associate Commissioner for Policy.
information, including any of the activities including: Healthy People,
[FR Doc. 2017–27276 Filed 12–18–17; 8:45 am]
following subjects: (1) The necessity and Dietary Guidelines for Americans,
BILLING CODE 4164–01–P
utility of the proposed information Physical Activity Guidelines for
collection for the proper performance of Americans, healthfinder.gov, and
the agency’s functions; (2) the accuracy increasing health care quality and
DEPARTMENT OF HEALTH AND
of the estimated burden; (3) ways to patient safety. ODPHP communicates
HUMAN SERVICES
enhance the quality, utility, and clarity through its websites
of the information to be collected; and (www.healthfinder.gov,
[Document Identifier: HHS–OS–0990–0281– www.HealthyPeople.gov,
(4) the use of automated collection
30D] www.health.gov) and through other
techniques or other forms of information
Agency Information Collection technology to minimize the information channels including social media, print
Request. 30-Day Public Comment collection burden. materials, interactive training modules,
Request Title of the Collection: Prevention and reports. This request builds on
Communication Formative Research— previous formative research approaches
AGENCY: Office of the Secretary, HHS. Revision—OMB No. 0990–0281. to place more emphasis on web-based
ACTION: Notice. Type of Collection: Revision. data collection to allow greater
OMB No.: 0990–0281—Office of geographical diversity among
SUMMARY: In compliance with the Disease Prevention and Health respondents, to decrease respondent
requirement of the Paperwork Promotion. burden, and to save government costs.
Reduction Act of 1995, the Office of the Abstract: The Office of Disease Data collection will be qualitative and
Secretary (OS), Department of Health Prevention and Health Promotion quantitative and may include in-depth
and Human Services, is publishing the (ODPHP) is focused on developing and interviews, focus groups, web-based
following summary of a proposed disseminating health information to the surveys, omnibus surveys, card sorting,
collection for public comment. public. ODPHP faces an increasingly and various forms of usability testing of
urgent interest in finding effective ways materials and interactive tools to assess
DATES: Comments on the ICR must be
to communicate health information to the public’s understanding of disease
received on or before January 18, 2018.
America’s diverse population. ODPHP prevention and health promotion
ADDRESSES: Submit your comments to strives to be responsive to the needs of
OIRA_submission@omb.eop.gov or via content, responses to prototype
America’s diverse audiences while materials, and barriers to effective use.
facsimile to (202) 395–5806. simultaneously serving all Americans
FOR FURTHER INFORMATION CONTACT: across a range of channels, from print to The program is requesting a 3-year
Sherrette Funn, Sherrette.Funn@hhs.gov new communication technologies. To clearance.
or (202) 795–7714. When submitting carry out prevention information efforts, Likely Respondents: Respondents are
comments or requesting information, ODPHP is committed to conducting likely to be either consumers or health
please include the document identifier formative and usability research to professionals.
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number Total response
Number of burden/
Data collection task Instrument/form name responses/ burden
respondents response
respondent (in hours)
(in hours)
In-depth interviews ............................ Screener ........................................... 1,500 1 10/60 250
Interview ........................................... 500 1 1.00 500
Focus groups .................................... Screener ........................................... 2,925 1 10/60 487.5
Focus Group .................................... 975 1 1.50 1,462.5
Intercept interviews ........................... Interview ........................................... 5,250 1 5/60 437.50
Cognitive testing of instruments ....... Screener ........................................... 150 1 10/60 25
Cognitive Test .................................. 50 1 2.00 100
Web-based surveys .......................... Screener ........................................... 30,000 1 5/60 2,500
Survey .............................................. 10,000 1 15/60 2,500
Omnibus surveys .............................. Survey .............................................. 2,100 1 10/60 350
Gatekeeper reviews .......................... Review .............................................. 325 1 30/60 162.5
Card sorting ...................................... Screener ........................................... 600 1 10/60 100
Card Sort .......................................... 200 1 1.00 200
Usability and prototype testing of Screener ........................................... 1,800 1 10/60 300
materials (print and web).
sradovich on DSK3GMQ082PROD with NOTICES
Usability Test .................................... 600 1 1.00 600
Total ........................................... ........................................................... ........................ ........................ ........................ 9,975.00
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Document Created: 2017-12-19 01:31:19
Document Modified: 2017-12-19 01:31:19
| 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 February 20, 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 60207 |
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