82 FR 13813 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 82, Issue 49 (March 15, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 49 (March 15, 2017)
| Page Range | 13813-13814 | |
| FR Document | 2017-05106 |
[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)] [Notices] [Pages 13813-13814] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-05106] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2013-N-1089] Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by April 14, 2017. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: (202) 395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0553. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]. 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. 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. [[Page 13814]] 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 the specific symbols used in labels or labeling for the IVDs manufactured. In the Federal Register of December 5, 2016 (81 FR 87570), FDA published a 60-day 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 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: March 9, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-05106 Filed 3-14-17; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices 13813
will provide the better understanding of audience will allow FDA to refine hours). FDA estimates the burden of this
target audiences that FDA needs to messages while still in the collection of information based on prior
design effective communication developmental stage. Respondents will recent experience with the various types
strategies, messages, and labels. These be asked to give their reaction to the of data collection methods described
communications will aim to improve messages in either individual or group earlier. FDA is requesting this burden so
public understanding of the risks and settings. as not to restrict the Agency’s ability to
benefits of using medical devices and Third, as evaluative research, it will gather information on public sentiment
radiation-emitting products by allow FDA to ascertain the effectiveness for its proposals in its regulatory and
providing users with a better context in of the messages and the distribution communications programs.
which to place risk information more method of these messages in achieving
In the Federal Register of October 28,
the objectives of the message campaign.
completely. 2016 (81 FR 75134), FDA published a
Evaluation of campaigns is a vital link
Second, as initial testing, it will allow in continuous improvement of 60-day notice requesting public
FDA to assess the potential effectiveness communications at FDA. comment on the proposed collection of
of messages and materials in reaching Annually, FDA projects about 30 information. No comments were
and successfully communicating with studies using a variety of research received.
their intended audiences. Testing methods and lasting an average of 0.17 FDA estimates the burden of this
messages with a sample of the target hours each (varying from 0.08 to 1.5 collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity responses per burden per Total hours
respondents responses
respondent response
Individual in-depth interviews ....................................... 360 1 360 .75 (45 minutes) .... 270
General public focus group interviews ......................... 144 1 144 1.5 ......................... 216
Intercept interviews: Central location ........................... 200 1 200 .25 (15 minutes) .... 50
Intercept interviews: Telephone ................................... 4,000 1 4,000 .08 (5 minutes) ...... 320
Self-administered surveys ............................................ 2,400 1 2,400 .25 (15 minutes) .... 600
Gatekeeper reviews ..................................................... 400 1 400 .5 (30 minutes) ...... 200
Omnibus surveys .......................................................... 1,200 1 1,200 .17 (10 minutes) .... 204
Total (general public) ............................................ 8,704 ........................ ........................ ............................... 1,860
Physician focus group interviews ................................. 144 1 144 1.5 ......................... 216
Total (physician) .................................................... 144 ........................ ........................ ............................... 216
Total (overall) ................................................. 8,848 ........................ ........................ ............................... 2,076
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Dated: March 9, 2017. that a proposed collection of SUPPLEMENTARY INFORMATION: In
Leslie Kux, information has been submitted to the compliance with 44 U.S.C. 3507, FDA
Associate Commissioner for Policy. Office of Management and Budget has submitted the following proposed
[FR Doc. 2017–05097 Filed 3–14–17; 8:45 am] (OMB) for review and clearance under collection of information to OMB for
BILLING CODE 4164–01–P
the Paperwork Reduction Act of 1995. review and clearance.
DATES: Fax written comments on the
Recommended Glossary and
collection of information by April 14, Educational Outreach To Support Use
DEPARTMENT OF HEALTH AND 2017. of Symbols on Labels and in Labeling
HUMAN SERVICES ADDRESSES: To ensure that comments on of In Vitro Diagnostic Devices Intended
Food and Drug Administration the information collection are received, for Professional Use
OMB recommends that written
[Docket No. FDA–2013–N–1089] comments be faxed to the Office of OMB Control Number 0910–0553—
Information and Regulatory Affairs, Extension
Agency Information Collection OMB, Attn: FDA Desk Officer, FAX: Section 502 of the Federal Food, Drug,
Activities; Submission for Office of (202) 395–7285, or emailed to oira_ and Cosmetic Act (the FD&C Act) (21
Management and Budget Review; submission@omb.eop.gov. All U.S.C. 352), among other things,
Comment Request; Recommended comments should be identified with the establishes requirements for the label or
Glossary and Educational Outreach To OMB control number 0910–0553. Also labeling of a medical device to avoid
Support Use of Symbols on Labels and include the FDA docket number found
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
misbranding. Section 351 of the Public
in Labeling of In Vitro Diagnostic in brackets in the heading of this Health Service Act (the PHS Act) (42
Devices Intended for Professional Use document. U.S.C. 262) establishes requirements
AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT: FDA that manufacturers of biological
HHS. PRA Staff, Office of Operations, Food products must submit a license
ACTION: Notice. and Drug Administration, Three White application for FDA review and
Flint North 10A–12M, 11601 approval prior to marketing a biological
SUMMARY: The Food and Drug Landsdown St., North Bethesda, MD product for introduction into interstate
Administration (FDA) is announcing 20852, PRAStaff@fda.hhs.gov. commerce.
VerDate Sep<11>2014 18:19 Mar 14, 2017 Jkt 241001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\15MRN1.SGM 15MRN1](https://thefederalregister.org/doc/82_FR_13862/page/1.svg)
![13814 Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices
In the Federal Register of November device’s labels and/or labeling. The glossary activity is inclusive of
30, 2004 (69 FR 69606), FDA published Furthermore, the guidance recommends both domestic and foreign IVD
a notice of availability of the guidance an educational outreach effort to manufacturers. FDA receives
entitled ‘‘Use of Symbols on Labels and enhance the understanding of newly submissions from approximately 689
in Labeling of In Vitro Diagnostic introduced symbols. Both the glossary IVD manufacturers annually. The 4-hour
Devices Intended for Professional Use.’’ and educational outreach information estimate for a glossary is based on the
The document provides guidance for the help to ensure that IVD users have average time necessary for a
voluntary use of selected symbols in enough general familiarity with the manufacturer to modify the glossary for
place of text in labeling. It provides the symbols used, as well as provide a quick the specific symbols used in labels or
labeling guidance required for: (1) In reference for available materials, thereby labeling for the IVDs manufactured.
vitro diagnostic devices (IVDs), further ensuring that such labeling
intended for professional use under 21 In the Federal Register of December 5,
satisfies the labeling requirements under 2016 (81 FR 87570), FDA published a
CFR 809.10, FDA’s labeling
section 502(c) of the FD&C Act and 60-day notice requesting public
requirements for IVDs; and (2) FDA’s
section 351 of the PHS Act. comment on the proposed collection of
labeling requirements for biologics,
including IVDs under 21 CFR parts 610 The likely respondents for this information. No comments were
and 660. collection of information are IVD received.
The guidance document recommends manufacturers who plan to use the
FDA estimates the burden of this
that a glossary of terms accompany each selected symbols in place of text on the
collection of information as follows:
IVD to define the symbols used on that labels and/or labeling of their IVDs.
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
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: March 9, 2017. solicits comments on the Safety manner detailed (see ‘‘Written/Paper
Leslie Kux, Communication Readership Survey. Submissions’’ and ‘‘Instructions’’).
Associate Commissioner for Policy. DATES: Submit either electronic or Written/Paper Submissions
[FR Doc. 2017–05106 Filed 3–14–17; 8:45 am] written comments on the collection of
information by May 15, 2017. Submit written/paper submissions as
BILLING CODE 4164–01–P
follows:
ADDRESSES: You may submit comments • Mail/Hand delivery/Courier (for
as follows: written/paper submissions): Division of
DEPARTMENT OF HEALTH AND
Electronic Submissions Dockets Management (HFA–305), Food
HUMAN SERVICES
and Drug Administration, 5630 Fishers
Submit electronic comments in the Lane, Rm. 1061, Rockville, MD 20852.
Food and Drug Administration following way: • For written/paper comments
• Federal eRulemaking Portal: submitted to the Division of Dockets
[Docket No. FDA–2009–N–0360] https://www.regulations.gov. Follow the Management, FDA will post your
instructions for submitting comments. comment, as well as any attachments,
Agency Information Collection
Comments submitted electronically, except for information submitted,
Activities; Proposed Collection;
including attachments, to https:// marked and identified, as confidential,
Comment Request; Food and Drug
www.regulations.gov will be posted to if submitted as detailed in
Administration Safety Communication
the docket unchanged. Because your ‘‘Instructions.’’
Readership Survey
comment will be made public, you are Instructions: All submissions received
AGENCY: Food and Drug Administration, solely responsible for ensuring that your must include the Docket No. FDA–
HHS. comment does not include any 2009–N–0360 for ‘‘Agency Information
ACTION: Notice. confidential information that you or a Collection Activities; Proposed
third party may not wish to be posted, Collection; Comment Request; Food and
SUMMARY: The Food and Drug such as medical information, your or Drug Administration Safety
Administration (FDA or Agency) is anyone else’s Social Security number, or Communication Readership Survey.’’
announcing an opportunity for public confidential business information, such Received comments will be placed in
comment on the proposed collection of as a manufacturing process. Please note the docket and, except for those
certain information by the Agency. that if you include your name, contact submitted as ‘‘Confidential
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
Under the Paperwork Reduction Act of information, or other information that Submissions,’’ publicly viewable at
1995 (PRA), Federal Agencies are identifies you in the body of your https://www.regulations.gov or at the
required to publish notice in the comments, that information will be Division of Dockets Management
Federal Register concerning each posted on https://www.regulations.gov. between 9 a.m. and 4 p.m., Monday
proposed collection of information, • If you want to submit a comment through Friday.
including each proposed extension of an with confidential information that you • Confidential Submissions—To
existing collection of information, and do not wish to be made available to the submit a comment with confidential
to allow 60 days for public comment in public, submit the comment as a information that you do not wish to be
response to the notice. This notice written/paper submission and in the made publicly available, submit your
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Document Created: 2017-03-15 06:04:52
Document Modified: 2017-03-15 06:04:52
| 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 | Fax written comments on the collection of information by April 14, 2017. | |
| Contact | FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, [email protected] | |
| FR Citation | 82 FR 13813 |
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