82 FR 30870 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; 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 126 (July 3, 2017)

Page Range		30870-30871
FR Document		2017-13884

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.

Federal Register, Volume 82 Issue 126 (Monday, July 3, 2017)

[Federal Register Volume 82, Number 126 (Monday, July 3, 2017)]
[Notices]
[Pages 30870-30871]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2017-13884]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-N-0360]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) 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 August 
2, 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 0910-0341. 
Also include the FDA docket number found in brackets in the heading of 
this document.

FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A63, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-8867, 
[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.

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 and obtain their 
voluntary responses 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.
    In the Federal Register of March 15, 2017 (82 FR 13814), 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:

[[Page 30871]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                         Number of
                              Activity                                  Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Public Health Notification Readership Survey.......................             300                3              900           * 0.17              153
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
* 10 minutes.

    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 voluntary response time is estimated at 10 
minutes per survey. This was derived by CDRH staff completing the 
survey.

    Dated: June 27, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-13884 Filed 6-30-17; 8:45 am]
 BILLING CODE 4164-01-P

30870 Federal Register / Vol. 82, No. 126 / Monday, July 3, 2017 / Notices

in a transaction into commerce by the Dated: June 28, 2017. 375(b)) gives FDA authority to
manufacturer between November 27, Anna K. Abram, disseminate information concerning
2017, and November 26, 2018, FDA Deputy Commissioner for Policy, Planning, suspected or imminent danger to public
does not intend to take action against: Legislation, and Analysis. health by any regulated product. Section
(1) Repackagers who accept ownership [FR Doc. 2017–13979 Filed 6–30–17; 8:45 am] 1701(a)(4) of the Public Health Service
of such product in a transaction; (2) BILLING CODE 4164–01–P Act (42 U.S.C. 300u(a)(4)) also
wholesale distributors who engage in authorizes FDA to conduct research
transactions involving such product; relating to health information.
and (3) dispensers who engage in DEPARTMENT OF HEALTH AND
transactions involving such product, or HUMAN SERVICES FDA’s Center for Devices and
repackagers, wholesale distributors, and Radiological Health (CDRH) carries out
dispensers who do not verify the Food and Drug Administration FDA’s regulatory responsibilities
product at the package level, using the [Docket No. FDA–2009–N–0360]
regarding medical devices and
product identifier, when investigating radiological products. CDRH must be
suspect product or for a saleable Agency Information Collection able to effectively communicate risk to
returned product as applicable. In Activities; Submission for Office of health care practitioners, patients,
addition, the guidance explains that Management and Budget Review; caregivers, and consumers when there is
FDA does not intend to take action Comment Request; Food and Drug a real or suspected threat to the public’s
against a manufacturer, repackager, or Administration Safety Communication health. CDRH uses safety
wholesale distributor who engages in Readership Survey communications to transmit information
certain prohibited acts involving concerning these risks to user
products that are misbranded based on AGENCY: Food and Drug Administration,
HHS. communities. Safety communications
lack of product identifier alone, where are released and available to
the package and/or homogeneous case ACTION: Notice.
organizations such as hospitals, nursing
of product that lacks a product identifier SUMMARY: The Food and Drug homes, hospices, home health care
was introduced in a transaction into Administration (FDA) is announcing agencies, manufacturers, retail
commerce by a manufacturer between that a proposed collection of
November 27, 2017, and November 26, pharmacies, and other health care
information has been submitted to the providers, as well as patients,
2018. The guidance document explains Office of Management and Budget
the scope of the compliance policy in caregivers, consumers, and patient
(OMB) for review and clearance under advocacy groups. Through a process for
further detail. FDA invites comment on the Paperwork Reduction Act of 1995.
the compliance policy, including identifying and addressing postmarket
DATES: Fax written comments on the safety issues related to regulated
comments on how manufacturers can
collection of information by August 2, products, CDRH determines when to
indicate the date they initially
2017. release safety communications.
introduced the product in a transaction
into commerce and how downstream ADDRESSES: To ensure that comments on
FDA seeks to evaluate the clarity,
trading partners can determine that the information collection are received, timeliness, and impact of safety
product was initially introduced by OMB recommends that written
communications by surveying a sample
manufacturers in a transaction into comments be faxed to the Office of
Information and Regulatory Affairs, of recipients and obtain their voluntary
commerce during that time period. responses to determine the impact of
This draft guidance is being issued OMB, Attn: FDA Desk Officer, FAX:
consistent with FDA’s good guidance 202–395–7285, or emailed to oira_ safety communications on the
practices regulation (21 CFR 10.115). submission@omb.eop.gov. All knowledge of the recipients.
The draft guidance, when finalized, will comments should be identified with the Understanding how the target audiences
represent the current thinking of FDA OMB control number 0910–0341. Also view these publications will aid in
on ‘‘Product Identifier Requirements include the FDA docket number found determining what, if any, changes
Under the Drug Supply Chain Security in brackets in the heading of this should be considered in their content,
Act—Compliance Policy.’’ It does not document. format, and method of dissemination.
establish any rights for any person and FOR FURTHER INFORMATION CONTACT: The collection of this data is an
is not binding on FDA or the public. Amber Sanford, Office of Operations, important step in determining how well
You can use an alternative approach if Food and Drug Administration, Three CDRH is communicating risk. The
it satisfies the requirements of the White Flint North 10A63, 11601 results from this survey will emphasize
applicable statutes and regulations. This Landsdown St., North Bethesda, MD the quality of the safety
is not a significant regulatory action 20852, 301–796–8867, PRAStaff@ communications and customer
subject to Executive Order 12866. fda.hhs.gov. satisfaction. This will enable us to better
II. Electronic Access SUPPLEMENTARY INFORMATION: In serve the public by improving the
compliance with 44 U.S.C. 3507, FDA effectiveness of safety communications.
Persons with access to the Internet
may obtain the draft guidance at https:// has submitted the following proposed In the Federal Register of March 15,
www.fda.gov/Drugs/ collection of information to OMB for 2017 (82 FR 13814), FDA published a
GuidanceComplianceRegulatory review and clearance. 60-day notice requesting public
comment on the proposed collection of
sradovich on DSK3GMQ082PROD with NOTICES

Information/Guidances/default.htm, FDA Safety Communication Readership
https://www.fda.gov/ Survey information. No comments were
BiologicsBloodVaccines/ received.
GuidanceCompliance OMB Control Number 0910–0341—
Extension FDA estimates the burden of this
RegulatoryInformation/Guidances/ collection of information as follows:
default.htm, or https:// Section 705(b) of the Federal Food,
www.regulations.gov. Drug, and Cosmetic Act (21 U.S.C.

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Federal Register / Vol. 82, No. 126 / Monday, July 3, 2017 / Notices 30871

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 * 0.17 153
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
* 10 minutes.

Based on the history of the Safety by the General Services Administration, name or description of duties, no
Communication program, it is estimated FDA is announcing the renewal of the amendment will be made to 21 CFR
that an average of three collections will Medical Imaging Drugs Advisory 14.100.
be conducted per year. The total burden Committee. The committee is a This document is issued under the
of voluntary response time is estimated discretionary Federal advisory Federal Advisory Committee Act (5
at 10 minutes per survey. This was committee established to provide advice U.S.C. app.). For general information
derived by CDRH staff completing the to the Commissioner. The Medical related to FDA advisory committees,
survey. Imaging Drugs Advisory Committee please visit us at https://www.fda.gov/
Dated: June 27, 2017. advises the Commissioner or designee AdvisoryCommittees/default.htm.
Anna K. Abram, in discharging responsibilities as they Dated: June 27, 2017.
Deputy Commissioner for Policy, Planning, relate to helping to ensure safe and Anna K. Abram,
Legislation, and Analysis. effective drugs for human use and, as Deputy Commissioner for Policy, Planning,
[FR Doc. 2017–13884 Filed 6–30–17; 8:45 am]
required, any other product for which Legislation, and Analysis.
BILLING CODE 4164–01–P
FDA has regulatory responsibility. [FR Doc. 2017–13885 Filed 6–30–17; 8:45 am]
The Committee reviews and evaluates
BILLING CODE 4164–01–P
data concerning the safety and
DEPARTMENT OF HEALTH AND effectiveness of marketed and
HUMAN SERVICES investigational human drug products for DEPARTMENT OF HEALTH AND
use in diagnostic and therapeutic HUMAN SERVICES
Food and Drug Administration procedures using radioactive
pharmaceuticals and contrast media Food and Drug Administration
[Docket No. FDA–2017–N–0001]
used in diagnostic radiology and makes
[Docket No. FDA–2013–N–1161]
Advisory Committee; Medical Imaging appropriate recommendations to the
Drugs Advisory Committee, Renewal Commissioner of Food and Drugs. Agency Information Collection
The Committee shall consist of a core Activities; Proposed Collection;
AGENCY: Food and Drug Administration, of 12 voting members including the
HHS. Comment Request; Food Safety
Chair. Members and the Chair are Survey
ACTION:Notice; renewal of advisory selected by the Commissioner or
committee. designee from among authorities AGENCY: Food and Drug Administration,
knowledgeable in the fields of nuclear HHS.
SUMMARY: The Food and Drug medicine, radiology, epidemiology or ACTION: Notice.
Administration (FDA) is announcing the statistics, and related specialties.
renewal of the Medical Imaging Drugs Members will be invited to serve for SUMMARY: The Food and Drug
Advisory Committee by the overlapping terms of up to 4 years. Administration (FDA or Agency) is
Commissioner of Food and Drugs (the Almost all non-Federal members of this announcing an opportunity for public
Commissioner). The Commissioner has committee serve as Special Government comment on the proposed collection of
determined that it is in the public Employees. The core of voting members certain information by the Agency.
interest to renew the Medical Imaging may include one technically qualified Under the Paperwork Reduction Act of
Drugs Advisory Committee for an member, selected by the Commissioner 1995 (PRA), Federal Agencies are
additional 2 years beyond the charter or designee, who is identified with required to publish notice in the
expiration date. The new charter will be consumer interests and is recommended Federal Register concerning each
in effect until May 18, 2019. by either a consortium of consumer- proposed collection of information,
DATES: Authority for the Medical oriented organizations or other including each proposed extension of an
Imaging Drugs Advisory Committee will interested persons. In addition to the existing collection of information, and
expire on May 18, 2017, unless the voting members, the Committee may to allow 60 days for public comment in
Commissioner formally determines that include one non-voting member who is response to the notice. This notice
renewal is in the public interest. identified with industry interests. solicits comments on a voluntary
FOR FURTHER INFORMATION CONTACT: Further information regarding the consumer survey entitled ‘‘Food Safety
Jennifer Shepherd, Center for Drug most recent charter and other Survey.’’
Evaluation and Research, Food and information can be found at https:// DATES: Submit either electronic or
Drug Administration, 10903 New www.fda.gov/AdvisoryCommittees/ written comments on the collection of
sradovich on DSK3GMQ082PROD with NOTICES

Hampshire Ave., Bldg. 31, Rm. 2417, CommitteesMeetingMaterials/Drugs/ information by September 1, 2017.
Silver Spring, MD 20993–0002, 301– MedicalImagingDrugsAdvisory ADDRESSES: You may submit comments
796–9001, email: MIDAC@fda.hhs.gov. Committee/ucm273284.htm or by as follows. Please note that late,
SUPPLEMENTARY INFORMATION: Pursuant contacting the Designated Federal untimely filed comments will not be
to 41 CFR 102–3.65 and approval by the Officer (see FOR FURTHER INFORMATION considered. Electronic comments must
Department of Health and Human CONTACT). In light of the fact that no be submitted on or before September 1,
Services pursuant to 45 CFR part 11 and change has been made to the committee 2017. The https://www.regulations.gov

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Document Created: 2018-11-14 10:19:50
Document Modified: 2018-11-14 10:19:50

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 August 2, 2017.
Contact		Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]
FR Citation		82 FR 30870

82 FR 30870 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Food and Drug Administration Safety Communication Readership Survey

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 126 (July 3, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration