81 FR 87570 - Agency Information Collection Activities; Proposed Collection; Comment Request; Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 233 (December 5, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 233 (December 5, 2016)
| Page Range | 87570-87572 | |
| FR Document | 2016-29104 |
[Federal Register Volume 81, Number 233 (Monday, December 5, 2016)] [Notices] [Pages 87570-87572] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-29104] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1089] Agency Information Collection Activities; Proposed Collection; Comment Request; Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the 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 recommended glossary and educational outreach to support use of symbols on labels and in labeling of in vitro diagnostic devices intended for professional use. DATES: Submit either electronic or written comments on the collection of information by February 3, 2017. ADDRESSES: You may submit comments as follows: 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 [[Page 87571]] 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): Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Division of Dockets Management, 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-2013-N-1089 for ``Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Division of Dockets Management 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 Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [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. Recommended Glossary and Educational Outreach To Support Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use--OMB Control Number 0910-0553--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 for the label or labeling of a medical device to avoid misbranding. Section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262) establishes requirements that manufacturers of biological products must submit a license application for FDA review and approval prior to marketing a biological product for introduction into interstate commerce. In the Federal Register of November 30, 2004 (69 FR 69606), FDA published a notice of availability of the guidance entitled ``Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use.'' The document provides guidance for the voluntary use of selected symbols in place of text in labeling. It provides the labeling guidance required for: (1) In vitro diagnostic devices (IVDs), intended for professional use under 21 CFR 809.10, FDA's labeling requirements for IVDs; and (2) FDA's labeling requirements for biologics, including IVDs under 21 CFR parts 610 and 660. The guidance document recommends that a glossary of terms accompany each IVD to define the symbols used on that device's labels and/or labeling. Furthermore, the guidance recommends an educational outreach effort to enhance the understanding of newly introduced symbols. Both the glossary and educational outreach information help to ensure that IVD users have enough general familiarity with the symbols used, as well as provide a quick reference for available materials, thereby further ensuring that such labeling satisfies the labeling requirements under section 502(c) of the FD&C Act and section 351 of the PHS Act. The likely respondents for this collection of information are IVD manufacturers who plan to use the selected symbols in place of text on the labels and/or labeling of their IVDs. The glossary activity is inclusive of both domestic and foreign IVD manufacturers. FDA receives submissions from approximately 689 IVD manufacturers annually. The 4-hour estimate for a glossary is based on the average time necessary for a manufacturer to modify the glossary for [[Page 87572]] the specific symbols used in labels or labeling for the IVDs manufactured. 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 -------------------------------------------------------------------------------------------------------------------------------------------------------- Glossary...................................................... 689 1 689 4 2,756 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: November 30, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-29104 Filed 12-2-16; 8:45 am] BILLING CODE 4164-01-P
![87570 Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices
Instructions: All submissions received Silver Spring, MD 20993, 301–796– DEPARTMENT OF HEALTH AND
must include the Docket No. FDA– 4714, Michelle.Eby@fda.hhs.gov. HUMAN SERVICES
2016–N–2896 for ‘‘Public Meeting on
SUPPLEMENTARY INFORMATION: In the Food and Drug Administration
Pre-Market Evaluation of Abuse-
Deterrent Properties of Opioid Drug Federal Register of October 6, 2016 (81
FR 69532), FDA published a notice [Docket No. FDA–2013–N–1089]
Products; Extension of Comment
Period.’’ Received comments will be announcing a public meeting and Agency Information Collection
placed in the docket and, except for requesting comments on the approach to Activities; Proposed Collection;
those submitted as ‘‘Confidential testing FDA recommended in its draft Comment Request; Recommended
Submissions,’’ publicly viewable at guidance ‘‘General Principles for Glossary and Educational Outreach To
https://www.regulations.gov or at the Evaluating the Abuse Deterrence of Support Use of Symbols on Labels and
Division of Dockets Management Generic Solid Oral Opioid Drug in Labeling of In Vitro Diagnostic
between 9 a.m. and 4 p.m., Monday Products’’ 1 and FDA’s efforts to develop Devices Intended for Professional Use
through Friday. standardized in vitro testing
methodologies for evaluating the abuse AGENCY: Food and Drug Administration,
• Confidential Submissions—To HHS.
submit a comment with confidential deterrence of opioid drug products. The
comment period ends on December 1, ACTION: Notice.
information that you do not wish to be
made publicly available, submit your 2016. Because the Agency has received SUMMARY: The Food and Drug
comments only as a written/paper requests for an extension to allow Administration (FDA) is announcing an
submission. You should submit two interested persons additional time to opportunity for public comment on the
copies total. One copy will include the submit comments, FDA is extending the proposed collection of certain
information you claim to be confidential comment period until January 3, 2017. information by the Agency. Under the
with a heading or cover note that states Additional comments specific to the Paperwork Reduction Act of 1995 (the
‘‘THIS DOCUMENT CONTAINS draft guidance ‘‘General Principles for PRA), Federal Agencies are required to
CONFIDENTIAL INFORMATION.’’ The Evaluating the Abuse Deterrence of publish notice in the Federal Register
Agency will review this copy, including Generic Solid Oral Opioid Drug concerning each proposed collection of
the claimed confidential information, in Products’’ should be submitted to the information, including each proposed
its consideration of comments. The extension of an existing collection of
docket for the draft guidance (FDA–
second copy, which will have the information, and to allow 60 days for
2016–D–0785) in lieu of, or in addition
claimed confidential information public comment in response to the
to, the docket for the public meeting. notice. This notice solicits comments on
redacted/blacked out, will be available
for public viewing and posted on Although you can comment on any recommended glossary and educational
https://www.regulations.gov. Submit guidance at any time (see 21 CFR outreach to support use of symbols on
both copies to the Division of Dockets 10.115(g)(5)), to ensure that the Agency labels and in labeling of in vitro
Management. If you do not wish your considers your comment on this draft diagnostic devices intended for
name and contact information to be guidance before it begins work on the professional use.
made publicly available, you can final version of the guidance, submit DATES: Submit either electronic or
provide this information on the cover either electronic or written comments written comments on the collection of
sheet and not in the body of your on the draft guidance by December 1, information by February 3, 2017.
comments and you must identify this 2016. Other comments should be ADDRESSES: You may submit comments
information as ‘‘confidential.’’ Any submitted to this docket by January 3, as follows:
information marked as ‘‘confidential’’ 2016. FDA has committed to taking
will not be disclosed except in steps to address the epidemic of opioid Electronic Submissions
accordance with 21 CFR 10.20 and other abuse transparently and in close Submit electronic comments in the
applicable disclosure law. For more cooperation with stakeholders and will following way:
information about FDA’s posting of provide other opportunities to • Federal eRulemaking Portal:
comments to public dockets, see 80 FR comment, as appropriate. For example, https://www.regulations.gov. Follow the
56469, September 18, 2015, or access FDA intends to issue a general guidance instructions for submitting comments.
the information at: http://www.fda.gov/ for public comment describing the Comments submitted electronically,
regulatoryinformation/dockets/ Agency’s recommendations for including attachments, to https://
default.htm. standardized in vitro testing to evaluate www.regulations.gov will be posted to
Docket: For access to the docket to purported abuse-deterrent properties the docket unchanged. Because your
read background documents or the comment will be made public, you are
and considerations for a potential
electronic and written/paper comments solely responsible for ensuring that your
applicant as it develops an abuse-
received, go to https:// comment does not include any
deterrent formulation of an opioid drug confidential information that you or a
www.regulations.gov and insert the product.
docket number, found in brackets in the third party may not wish to be posted,
heading of this document, into the Dated: November 29, 2016. such as medical information, your or
‘‘Search’’ box and follow the prompts Leslie Kux, anyone else’s Social Security number, or
and/or go to the Division of Dockets Associate Commissioner for Policy. confidential business information, such
sradovich on DSK3GMQ082PROD with NOTICES
Management, 5630 Fishers Lane, Rm. [FR Doc. 2016–29097 Filed 12–2–16; 8:45 am]
as a manufacturing process. Please note
1061, Rockville, MD 20852. that if you include your name, contact
BILLING CODE 4164–01–P
information, or other information that
FOR FURTHER INFORMATION CONTACT: identifies you in the body of your
Michelle Eby, Center for Drug comments, that information will be
Evaluation and Research, Food and 1 http://www.fda.gov/ucm/groups/fdagov-public/ posted on https://www.regulations.gov.
Drug Administration, 10903 New @fdagov-drugs-gen/documents/document/ • If you want to submit a comment
Hampshire Ave., Bldg. 51, Rm. 6184, ucm492172.pdf. with confidential information that you
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![87572 Federal Register / Vol. 81, No. 233 / Monday, December 5, 2016 / Notices
the specific symbols used in labels or FDA estimates the burden of this
labeling for the IVDs manufactured. collection of information as follows:
TABLE 1—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of Total Average
Number of Total
Activity disclosures per annual burden per
respondents hours
respondent disclosures disclosure
Glossary ..................................................................... 689 1 689 4 2,756
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: November 30, 2016. collection of information to OMB for Model for Quality Assurance in Design/
Leslie Kux, review and clearance. Development, Production, Installation,
Associate Commissioner for Policy. and Servicing.’’ The CGMP/QS
Medical Device: Current Good
[FR Doc. 2016–29104 Filed 12–2–16; 8:45 am] information collections will assist FDA
Manufacturing Practice Quality System
BILLING CODE 4164–01–P inspections of manufacturers for
Regulations— OMB Control Number
compliance with QS requirements
0910–0073—Extension
encompassing design, production,
DEPARTMENT OF HEALTH AND Under section 520(f) of the Federal installation, and servicing processes.
HUMAN SERVICES Food, Drug, and Cosmetic Act (the Section 820.20(a) through (e) requires
FD&C Act) (21 U.S.C. 360j(f)), the management with executive
Food and Drug Administration Secretary of the Department of Health responsibility to establish, maintain,
[Docket No. FDA–2016–N–2544] and Human Services has the authority and/or review the following topics: (1)
to prescribe regulations requiring that The quality policy, (2) the
Agency Information Collection the methods used in, and the facilities organizational structure, (3) the quality
Activities; Submission for Office of and controls used for, the manufacture, plan, and (4) the quality system
Management and Budget Review; preproduction design validation procedures of the organization. Section
Comment Request; Medical Device: (including a process to assess the 820.22 requires the conduct and
Current Good Manufacturing Practice performance of a device, but not documentation of QS audits and re-
Quality System Regulations including an evaluation of the safety audits. Section 820.25(b) requires the
and effectiveness of a device), packing, establishment of procedures to identify
AGENCY: Food and Drug Administration, storage, and installation of a device training needs and documentation of
HHS. conform to Current Good Manufacturing such training.
ACTION: Notice. Practice (CGMP), as described in such Section 820.30(a)(1) and (b) through
SUMMARY: The Food and Drug regulations, to assure that the device (j) requires, in respective order, the
Administration (FDA) is announcing will be safe and effective and otherwise establishment, maintenance, and/or
that a proposed collection of in compliance with the FD&C Act. documentation of the following topics:
information has been submitted to the The CGMP/Quality System (QS) (1) Procedures to control design of class
Office of Management and Budget regulation implementing authority III and class II devices and certain class
(OMB) for review and clearance under provided by this statutory provision is I devices as listed therein; (2) plans for
the Paperwork Reduction Act of 1995. found under part 820 (21 CFR part 820) design and development activities and
and sets forth basic CGMP requirements updates; (3) procedures identifying,
DATES: Fax written comments on the
governing the design, manufacture, documenting, and approving design
collection of information by January 4,
packing, labeling, storage, installation, input requirements; (4) procedures
2017.
and servicing of all finished medical defining design output, including
ADDRESSES: To ensure that comments on
devices intended for human use. The acceptance criteria, and documentation
the information collection are received, authority for this regulation is covered of approved records; (5) procedures for
OMB recommends that written under sections 501, 502, 510, 513, 514, formal review of design results and
comments be faxed to the Office of 515, 518, 519, 520, 522, 701, 704, 801, documentation of results in the design
Information and Regulatory Affairs, and 803 of the FD&C Act (21 U.S.C. 351, history file (DHF); (6) procedures for
OMB, Attn: FDA Desk Officer, FAX: 352, 360, 360c, 360d, 360e, 360h, 360i, verifying device design and
202–395–7285, or emailed to oira_ 360j, 360l, 371, 374, 381, and 383). The documentation of results and approvals
submission@omb.eop.gov. All CGMP/QS regulation includes in the DHF; (7) procedures for validating
comments should be identified with the requirements for purchasing and service device design, including documentation
OMB control number 0910–0073. Also controls, clarifies recordkeeping of results in the DHF; (8) procedures for
include the FDA docket number found requirements for device failure and translating device design into
in brackets in the heading of this complaint investigations, clarifies production specifications; (9)
document. requirements for verifying/validating procedures for documenting, verifying,
FOR FURTHER INFORMATION CONTACT: FDA production processes and process or and validating approved design changes
PRA Staff, Office of Operations, Food product changes, and clarifies before implementation of changes; and
sradovich on DSK3GMQ082PROD with NOTICES
and Drug Administration, Three White requirements for product acceptance (10) the records and references
Flint North, 10A63, 11601 Landsdown activities quality data evaluations and constituting the DHF for each type of
St., North Bethesda, MD 20852, corrections of nonconforming product/ device.
PRAStaff@fda.hhs.gov. quality problems. Section 820.40 requires manufacturers
SUPPLEMENTARY INFORMATION: In Requirements are compatible with to establish and maintain procedures
compliance with 44 U.S.C. 3507, FDA specifications in the international controlling approval and distribution of
has submitted the following proposed standards ‘‘ISO 9001: Quality Systems required documents and document
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Document Created: 2016-12-03 00:25:54
Document Modified: 2016-12-03 00:25:54
| 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 3, 2017. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A63, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 81 FR 87570 |
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