83 FR 36607 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 146 (July 30, 2018)

Page Range		36607-36608
FR Document		2018-16156

The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

Federal Register, Volume 83 Issue 146 (Monday, July 30, 2018)

[Federal Register Volume 83, Number 146 (Monday, July 30, 2018)]
[Notices]
[Pages 36607-36608]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-16156]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2014-N-1069; FDA-2017-N-6931; FDA-2011-N-0362; FDA-
2011-N-0279; FDA-2011-N-0672; FDA-2014-N-0913; FDA-2017-N-0493; and 
FDA-2011-N-0781]


Agency Information Collection Activities; Announcement of Office 
of Management and Budget Approvals

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is publishing a list of 
information collections that have been approved by the Office of 
Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations, 
Food and Drug Administration, Three White Flint North, 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 301-796-7726, 
PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: The following is a list of FDA information 
collections recently approved by OMB under section 3507 of the 
Paperwork Reduction Act of 1995 (44 U.S.C. 3507). The OMB control 
number and expiration date of OMB approval for each information 
collection are shown in table 1. Copies of the supporting statements 
for the information collections are available on the internet at 
https://www.reginfo.gov/public/do/PRAMain. An Agency may not conduct or 
sponsor, and a person is not required to respond to, a collection of 
information unless it displays a currently valid OMB control number.

[[Page 36608]]



        Table 1--List of Information Collections Approved by OMB
------------------------------------------------------------------------
                                            OMB control    Date approval
           Title of collection                  No.           expires
------------------------------------------------------------------------
Blood Establishment Registration and           0910-0052       6/30/2021
 Product Listing for Manufacturers of
 Human Blood and Blood Products and
 Licensed Devices; Form FDA 2830........
Current Good Manufacturing Practices and       0910-0116       6/30/2021
 Related Regulations for Blood and Blood
 Components; and Requirements for
 Donation Testing, Donor Notification,
 and ``Lookback''.......................
Current Good Manufacturing Practices for       0910-0139       6/30/2021
 Finished Pharmaceuticals and Medical
 Gases..................................
Prescription Drug Marketing.............       0910-0435       6/30/2021
Prominent and Conspicuous Mark of              0910-0577       6/30/2021
 Manufacturers on Single-Use Devices....
Guidance FDA and Industry Procedures for       0910-0705       6/30/2021
 Section 513(g) Requests for Information
 under the Federal Food, Drug, and
 Cosmetic Act...........................
Utilization of Adequate Provision Among        0910-0853       6/30/2021
 Low to Non-Internet Users..............
Record Retention Requirements for the          0910-0428       7/31/2021
 Soy Protein/Coronary Heart Disease
 Health Claim...........................
------------------------------------------------------------------------


    Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16156 Filed 7-27-18; 8:45 am]
 BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 146 / Monday, July 30, 2018 / Notices 36607

make recommendations on specific Representatives from the consumer participating in the selection process
issues or problems concerning the safety health branches of Federal, State, and with the opportunity to vote on the
and effectiveness of devices. With the local governments also may participate listed nominees. Only organizations
exception of the Medical Devices in the selection process. Any consumer vote in the selection process. Persons
Dispute Resolution Panel, each panel, organization interested in participating who nominate themselves to serve as
according to its specialty area, may also in the selection of an appropriate voting voting or nonvoting consumer
make appropriate recommendations to or nonvoting member to represent representatives will not participate in
the Commissioner of Food and Drugs on consumer interests should send a letter the selection process.
issues relating to the design of clinical stating that interest to FDA (see This notice is issued under the
studies regarding the safety and ADDRESSES) within 30 days of Federal Advisory Committee Act (5
effectiveness of marketed and publication of this document. U.S.C. app. 2) and 21 CFR part 14,
investigational devices. Within the subsequent 30 days, FDA relating to advisory committees.
The Dental Products Panel also will compile a list of consumer
Dated: July 24, 2018.
functions at times as a dental drug organizations that will participate in the
selection process and will forward to Leslie Kux,
panel. The functions of the dental drug
panel are to evaluate and recommend each such organization a ballot listing at Associate Commissioner for Policy.
whether various prescription drug least two qualified nominees selected by [FR Doc. 2018–16161 Filed 7–27–18; 8:45 am]
products should be changed to over-the- the Agency based on the nominations BILLING CODE 4164–01–P
counter status and to evaluate data and received, together with each nominee’s
make recommendations concerning the current curriculum vitae or resume.
approval of new dental drug products Ballots are to be filled out and returned DEPARTMENT OF HEALTH AND
for human use. to FDA within 30 days. The nominee HUMAN SERVICES
The Medical Devices Dispute receiving the highest number of votes
Resolution Panel provides advice to the ordinarily will be selected to serve as Food and Drug Administration
Commissioner on complex or contested the member representing consumer
scientific issues between FDA and interests for that particular advisory [Docket Nos. FDA–2014–N–1069; FDA–
medical device sponsors, applicants, or committee or panel. 2017–N–6931; FDA–2011–N–0362; FDA–
manufacturers relating to specific 2011–N–0279; FDA–2011–N–0672; FDA–
IV. Nomination Procedures 2014–N–0913; FDA–2017–N–0493; and
products, marketing applications, FDA–2011–N–0781]
regulatory decisions and actions by Any interested person or organization
FDA, and Agency guidance and may nominate one or more qualified
Agency Information Collection
policies. The Panel makes persons to represent consumer interests
Activities; Announcement of Office of
recommendations on issues that are on the Agency’s advisory committees or
Management and Budget Approvals
lacking resolution, are highly complex panels. Self-nominations are also
in nature, or result from challenges to accepted. Nominations must include a AGENCY: Food and Drug Administration,
regular advisory panel proceedings or current, complete resume or curriculum HHS.
Agency decisions or actions. vitae for each nominee and a signed ACTION: Notice.
copy of the Acknowledgement and
II. Criteria for Members Consent form available at the FDA SUMMARY: The Food and Drug
Persons nominated for membership as Advisory Nomination Portal (see Administration (FDA) is publishing a
consumer representatives on ADDRESSES), and a list of consumer or list of information collections that have
committees or panels should meet the community-based organizations for been approved by the Office of
following criteria: (1) Demonstrate an which the candidate can demonstrate Management and Budget (OMB) under
affiliation with and/or active active participation. the Paperwork Reduction Act of 1995.
participation in consumer or Nominations must also specify the
FOR FURTHER INFORMATION CONTACT: Ila
community-based organizations, (2) be advisory committee(s) or panel(s) for
S. Mizrachi, Office of Operations, Food
able to analyze technical data, (3) which the nominee is recommended. In
and Drug Administration, Three White
understand research design, (4) discuss addition, nominations must also
Flint North, 10A–12M, 11601
benefits and risks, and (5) evaluate the acknowledge that the nominee is aware
Landsdown St., North Bethesda, MD
safety and efficacy of products under of the nomination unless self-
20852, 301–796–7726, PRAStaff@
review. The consumer representative nominated. FDA will ask potential
fda.hhs.gov.
should be able to represent the candidates to provide detailed
consumer perspective on issues and information concerning such matters as SUPPLEMENTARY INFORMATION: The
actions before the advisory committee; financial holdings, employment, and following is a list of FDA information
serve as a liaison between the research grants and/or contracts to collections recently approved by OMB
committee and interested consumers, permit evaluation of possible sources of under section 3507 of the Paperwork
associations, coalitions, and consumer conflicts of interest. Members will be Reduction Act of 1995 (44 U.S.C. 3507).
organizations; and facilitate dialogue invited to serve for terms up to 4 years. The OMB control number and
with the advisory committees on FDA will review all nominations expiration date of OMB approval for
scientific issues that affect consumers. received within the specified each information collection are shown
timeframes and prepare a ballot in table 1. Copies of the supporting
III. Selection Procedures containing the names of qualified statements for the information
daltland on DSKBBV9HB2PROD with NOTICES

Selection of members representing nominees. Names not selected will collections are available on the internet
consumer interests is conducted remain on a list of eligible nominees at https://www.reginfo.gov/public/do/
through procedures that include the use and be reviewed periodically by FDA to PRAMain. An Agency may not conduct
of organizations representing the public determine continued interest. Upon or sponsor, and a person is not required
interest and public advocacy groups. selecting qualified nominees for the to respond to, a collection of
These organizations recommend ballot, FDA will provide those information unless it displays a
nominees for the Agency’s selection. consumer organizations that are currently valid OMB control number.

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Document Created: 2018-07-28 01:44:42
Document Modified: 2018-07-28 01:44:42

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.
Contact		Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726, [email protected]
FR Citation		83 FR 36607

83 FR 36607 - Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 146 (July 30, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration