82 FR 13814 - Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Safety Communication Readership Survey
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 | 13814-13815 | |
| FR Document | 2017-05103 |
[Federal Register Volume 82, Number 49 (Wednesday, March 15, 2017)] [Notices] [Pages 13814-13815] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-05103] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-N-0360] Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Safety Communication Readership Survey 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 the Safety Communication Readership Survey. DATES: Submit either electronic or written comments on the collection of information by May 15, 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 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-2009-N-0360 for ``Agency Information Collection Activities; Proposed Collection; Comment Request; Food and Drug Administration Safety Communication Readership Survey.'' 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 [[Page 13815]] 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 http://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. FDA Safety Communication Readership Survey OMB Control Number 0910-0341--Extension Section 705(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 375(b)) gives FDA authority to disseminate information concerning suspected or imminent danger to public health by any regulated product. Section 1701(a)(4) of the Public Health Service Act (42 U.S.C. 300u(a)(4)) also authorizes FDA to conduct research relating to health information. FDA's Center for Devices and Radiological Health (CDRH) carries out FDA's regulatory responsibilities regarding medical devices and radiological products. CDRH must be able to effectively communicate risk to health care practitioners, patients, caregivers, and consumers when there is a real or suspected threat to the public's health. CDRH uses safety communications to transmit information concerning these risks to user communities. Safety communications are released and available to organizations such as hospitals, nursing homes, hospices, home health care agencies, manufacturers, retail pharmacies, and other health care providers, as well as patients, caregivers, consumers, and patient advocacy groups. Through a process for identifying and addressing postmarket safety issues related to regulated products, CDRH determines when to release safety communications. FDA seeks to evaluate the clarity, timeliness, and impact of safety communications by surveying a sample of recipients to determine the impact of safety communications on the knowledge of the recipients. Understanding how the target audiences view these publications will aid in determining what, if any, changes should be considered in their content, format, and method of dissemination. The collection of this data is an important step in determining how well CDRH is communicating risk. The results from this survey will emphasize the quality of the safety communications and customer satisfaction. This will enable us to better serve the public by improving the effectiveness of safety communications. FDA estimates the burden of this collection of information as follows: Table 1--Estimated Annual Reporting Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Activity Number of responses per Total annual Average burden per response Total hours respondents respondent responses -------------------------------------------------------------------------------------------------------------------------------------------------------- Public Health Notification Readership Survey 300 3 900 0.17 (10 minutes)..................... 153 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Based on the history of the Safety Communication program, it is estimated that an average of three collections will be conducted per year. The total burden of response time is estimated at 10 minutes per survey. This was derived by CDRH staff completing the survey. Dated: March 9, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-05103 Filed 3-14-17; 8:45 am] BILLING CODE 4164-01-P
![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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![Federal Register / Vol. 82, No. 49 / Wednesday, March 15, 2017 / Notices 13815
comments only as a written/paper Agencies must obtain approval from the health by any regulated product. Section
submission. You should submit two Office of Management and Budget 1701(a)(4) of the Public Health Service
copies total. One copy will include the (OMB) for each collection of Act (42 U.S.C. 300u(a)(4)) also
information you claim to be confidential information they conduct or sponsor. authorizes FDA to conduct research
with a heading or cover note that states ‘‘Collection of information’’ is defined relating to health information.
‘‘THIS DOCUMENT CONTAINS in 44 U.S.C. 3502(3) and 5 CFR FDA’s Center for Devices and
CONFIDENTIAL INFORMATION.’’ The 1320.3(c) and includes Agency requests Radiological Health (CDRH) carries out
Agency will review this copy, including or requirements that members of the FDA’s regulatory responsibilities
the claimed confidential information, in public submit reports, keep records, or regarding medical devices and
its consideration of comments. The provide information to a third party. radiological products. CDRH must be
second copy, which will have the Section 3506(c)(2)(A) of the PRA (44 able to effectively communicate risk to
claimed confidential information U.S.C. 3506(c)(2)(A)) requires Federal health care practitioners, patients,
redacted/blacked out, will be available Agencies to provide a 60-day notice in caregivers, and consumers when there is
for public viewing and posted on http:// the Federal Register concerning each a real or suspected threat to the public’s
www.regulations.gov. Submit both proposed collection of information, health. CDRH uses safety
copies to the Division of Dockets including each proposed extension of an communications to transmit information
Management. If you do not wish your existing collection of information, concerning these risks to user
name and contact information to be before submitting the collection to OMB communities. Safety communications
made publicly available, you can for approval. To comply with this are released and available to
provide this information on the cover requirement, FDA is publishing notice organizations such as hospitals, nursing
sheet and not in the body of your of the proposed collection of homes, hospices, home health care
comments and you must identify this information set forth in this document. agencies, manufacturers, retail
information as ‘‘confidential.’’ Any With respect to the following pharmacies, and other health care
information marked as ‘‘confidential’’ collection of information, FDA invites providers, as well as patients,
will not be disclosed except in comments on these topics: (1) Whether caregivers, consumers, and patient
accordance with 21 CFR 10.20 and other the proposed collection of information advocacy groups. Through a process for
applicable disclosure law. For more is necessary for the proper performance identifying and addressing postmarket
information about FDA’s posting of of FDA’s functions, including whether safety issues related to regulated
comments to public dockets, see 80 FR the information will have practical products, CDRH determines when to
56469, September 18, 2015, or access utility; (2) the accuracy of FDA’s release safety communications.
the information at: http://www.fda.gov/ estimate of the burden of the proposed FDA seeks to evaluate the clarity,
regulatoryinformation/dockets/ collection of information, including the timeliness, and impact of safety
default.htm. validity of the methodology and communications by surveying a sample
Docket: For access to the docket to assumptions used; (3) ways to enhance of recipients to determine the impact of
read background documents or the the quality, utility, and clarity of the safety communications on the
electronic and written/paper comments information to be collected; and (4) knowledge of the recipients.
received, go to https:// ways to minimize the burden of the Understanding how the target audiences
www.regulations.gov and insert the collection of information on view these publications will aid in
docket number, found in brackets in the respondents, including through the use determining what, if any, changes
heading of this document, into the of automated collection techniques, should be considered in their content,
‘‘Search’’ box and follow the prompts when appropriate, and other forms of format, and method of dissemination.
and/or go to the Division of Dockets information technology. The collection of this data is an
Management, 5630 Fishers Lane, Rm. important step in determining how well
FDA Safety Communication Readership
1061, Rockville, MD 20852. CDRH is communicating risk. The
Survey
FOR FURTHER INFORMATION CONTACT: FDA results from this survey will emphasize
PRA Staff, Office of Operations, Food OMB Control Number 0910–0341— the quality of the safety
and Drug Administration, Three White Extension communications and customer
Flint North, 10A63, 11601 Landsdown Section 705(b) of the Federal Food, satisfaction. This will enable us to better
St., North Bethesda, MD 20852, Drug, and Cosmetic Act (21 U.S.C. serve the public by improving the
PRAStaff@fda.hhs.gov. 375(b)) gives FDA authority to effectiveness of safety communications.
SUPPLEMENTARY INFORMATION: Under the disseminate information concerning FDA estimates the burden of this
PRA (44 U.S.C. 3501–3520), Federal suspected or imminent danger to public 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
Public Health Notification Readership Survey ............. 300 3 900 0.17 (10 minutes) .. 153
asabaliauskas on DSK3SPTVN1PROD with NOTICES2
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the history of the Safety minutes per survey. This was derived by Dated: March 9, 2017.
Communication program, it is estimated CDRH staff completing the survey. Leslie Kux,
that an average of three collections will Associate Commissioner for Policy.
be conducted per year. The total burden [FR Doc. 2017–05103 Filed 3–14–17; 8:45 am]
of response time is estimated at 10 BILLING CODE 4164–01–P
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Document Created: 2017-03-15 06:04:12
Document Modified: 2017-03-15 06:04:12
| 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 May 15, 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 | 82 FR 13814 |
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