[Federal Register Volume 82, Number 117 (Tuesday, June 20, 2017)]
[Notices]
[Pages 28074-28075]
[FR Doc No: 2017-12782]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1496]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Food and Drug
Administration Rapid Response Surveys (Generic Clearance)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 July
20, 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:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0500.
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,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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 Rapid Response Surveys (Generic Collection)

OMB Control Number 0910-0500--Extension

    Section 505 of the Federal Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 355) requires that important safety information
relating to all human prescription drug products be made available to
FDA so that it can take appropriate action to protect the public health
when necessary. Section 702 of the FD&C Act (21 U.S.C. 372) authorizes
investigational powers to FDA for enforcement of the FD&C Act. Under
section 519 of the FD&C Act (21 U.S.C. 360i), FDA is authorized to
require manufacturers to report medical device-related deaths, serious
injuries, and malfunctions to FDA; to require user facilities to report
device-related deaths directly to FDA and to manufacturers; and to
report serious injuries to the manufacturer. Section 522 of the FD&C
Act (21 U.S.C. 360l) authorizes FDA to require manufacturers to conduct
postmarket surveillance of medical devices. Section 705(b) of the FD&C
Act (21 U.S.C. 375(b)) authorizes FDA to collect and disseminate
information regarding medical products or cosmetics in situations
involving imminent danger to health or gross deception of the consumer.
Section 1003(d)(2) of the FD&C Act (21 U.S.C. 393(d)(2)) authorizes the
Commissioner of Food and Drugs to implement general powers (including
conducting research) to carry out effectively the mission of FDA. These
sections of the FD&C Act enable FDA to enhance consumer protection from
risks associated with medical products usage that are not foreseen or
apparent during the premarket notification and review process. FDA's
regulations governing application for Agency approval to market a new
drug (21 CFR part 314) and regulations governing biological products
(21 CFR part 600) implement these statutory provisions. Currently, FDA
monitors medical product related postmarket adverse events via both the
mandatory and voluntary MedWatch reporting systems using FDA Forms 3500
and 3500A (OMB control number 0910-0291) and the vaccine adverse event
reporting system.
    FDA is seeking OMB clearance to collect vital information via a
series of rapid response surveys. Participation in these surveys will
be voluntary. This request covers rapid response surveys for community
based health care professionals, general type medical facilities,
specialized medical facilities (those known for cardiac surgery,
obstetrics/gynecology services, pediatric services, etc.), other health
care professionals, patients, consumers, and risk managers working in
medical facilities. FDA will use the information gathered from these
surveys to quickly obtain vital information about medical product risks
and interventions to reduce risks so the Agency may take appropriate
public health or regulatory action including dissemination of this
information as necessary and appropriate.
    FDA projects 6 emergency risk related surveys per year with a
sample of between 50 and 10,000 respondents per survey. FDA also
projects a response time of 0.5 hour per response. These estimates are
based on the maximum sample size per questionnaire that FDA may be able
to obtain by working with health care professional organizations. The
annual number of surveys was determined by the maximum number of
surveys per year FDA has ever conducted under this collection.
    In the Federal Register of January 13, 2017 (82 FR 4354), 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 Reporting Burden \1\
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                                                                 Number of
                  Activity                       Number of    responses  per   Total  annual         Average  burden per  response          Total hours
                                                respondents      respondent      responses
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FDA Rapid Response Survey...................          10,000               6          60,000  0.5 (30 minutes)..........................          30,000
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    Dated: June 14, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-12782 Filed 6-19-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: April 16, 2007 (Volume 72, Number 72)]
[Notices]
[Page 18985-18987]
[DOCID:fr16ap07-75]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2006-0721; FRL-8299-6]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NESHAP for Mineral Wool
Production (Renewal), EPA ICR Number 1799.04, OMB Control Number 2060-
0362

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. This ICR is scheduled to expire on June 30, 2007.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
This ICR describes the nature of the information collection and its
estimated burden and cost.

DATES: Additional comments may be submitted on or before May 16, 2007.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2006-0721, to (1) EPA online using http://www.regulations.gov (our preferred method), by e-mail to<EMAIL_ADDRESS>or by mail to: EPA

Docket Center (EPA/DC), Environmental Protection Agency, Enforcement
and Compliance Docket and Information Center, Mail Code 2201T, 1200
Pennsylvania Avenue, NW., Washington, DC 20460, and (2) OMB at: Office
of Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Compliance Assessment
and Media Programs Division, Office of Compliance, Mail Code 2223A,
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On October 5, 2006 (71 FR 38853), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments.
    EPA has established a public docket for this ICR under Docket ID
Number EPA-HQ-OECA-2006-0721, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Enforcement and

Compliance Docket and Information Center in the EPA Docket Center (EPA/
DC), EPA West, Room 3334, 1301 Constitution Avenue, NW., Washington,
DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for the Enforcement and Compliance Docket Center is
(202) 566-1927.
    Use EPA's electronic docket and comment system at http://www.epa.gov
, to submit or view public comments, access the index

listing of the contents of the docket, and to access those documents in
the docket that are available electronically. Once in the system,
select ``docket search,'' then key in the docket ID number identified
above. Please note that EPA's policy is that public comments, whether
submitted electronically or in paper, will be made available for public
viewing at http://www.regulations.gov, as EPA receives them and without

change, unless the comment contains copyrighted material, CBI, or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to
http://www.regulations.gov.

    Title: NESHAP for Mineral Wool Production (Renewal).
    ICR Numbers: EPA ICR Number 1799.04, OMB Control Number 2060-0362.
    ICR Status: This ICR is scheduled to expire on June 30, 2007. Under
OMB regulations, the Agency may continue to conduct or sponsor the
collection of information while this submission is pending at OMB. 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. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, are displayed either by
publication in the Federal Register or by other appropriate means, such
as on the related collection instrument or form, if applicable. The
display of OMB control numbers in certain EPA regulations is
consolidated in 40 CFR part 9.
    Abstract: The National Emission Standards for Hazardous Air
Pollutants (NESHAP) for Mineral Wool Production (40 CFR part 63,
subpart DDD) were proposed on May 8, 1997, and promulgated on June 1,
1999. Owners/operators of mineral wool production plants are required
to install fabric filter bag leak detection systems and then initiate
corrective action procedures in the event of an operating problem.
Owners/operators subject to NESHAP subpart DDD must also continuously
monitor and record: (1) The operating temperature of each thermal
incinerator, (2) cupola production (melt) rate; and (3) for each curing
oven, the formaldehyde content of each binder formulation used to
manufacture bonded products.
    Owners/operators of affected mineral wool production facility must
submit initial notifications (where applicable) performance test and
periodic reports. Owners or operators are also required to maintain
records of the occurrence and duration of any startup, shutdown, or
malfunction in the operation of an affected facility, or any period
during which the monitoring system is inoperative. Semiannual reports
are also required. These notifications, reports, and records are
essential in determining compliance; and are required, in general, of
all sources subject to NESHAP.
    Any owner or operator subject to the provisions of this part shall
maintain a file of these measurements, and retain the file for at least
five years following the date of such measurements, maintain reports
and records. All reports are sent to the delegated State or local
authority. In the event that there is no such delegated authority, the
reports are sent directly to the EPA regional office. This information
is being collected to assure compliance with 40 CFR part 63, subpart
DDD as authorized in section 112 and 114(a) of the Clean Air Act. The
required information consists of emissions data and other information
that have been determined to be private.
    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. The OMB Control Numbers for EPA's
regulations are listed in 40 CFR part 9 and 48 CFR chapter 15, and are
identified on the form and/or instrument, if applicable.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to average 126
hours per response. Burden means the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. This
includes the time needed to review instructions; develop, acquire,
install, and utilize technology and systems for the purposes of
collecting, validating, and verifying information, processing and
maintaining information, and disclosing and providing information;
adjust the existing ways to comply with any previously applicable
instructions and requirements; train personnel to be able to respond to
a collection of information; search data sources; complete and review
the collection of

information; and transmit or otherwise disclose the information.
    Respondents/Affected Entities: Mineral wool production.
    Estimated Number of Respondents: 12.
    Frequency of Response: Initially, and semiannually.
    Estimated Total Annual Hour Burden: 3,018.
    Estimated Total Capital and Operations & Maintenance (O&M) Annual
Costs: $9,000, which includes no annualized capital/startup costs and
$9,000 in annual O&M costs.
    Changes in the Estimates: There is no change in the labor hours or
cost in this ICR compared to the previous ICR. This is due to two
considerations. First, the regulations have not changed over the past
three years and are not anticipated to change over the next three
years. Secondly, the growth rate for the industry is very low, negative
or non-existent, so there is no significant change in the overall
burden.

    Dated: April 9, 2007.
Robert Gunter,
Acting Director, Collection Strategies Division.
 [FR Doc. E7-7141 Filed 4-13-07; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 170 (Tuesday, September 3, 2019)]
[Notices]
[Pages 46004-46005]
[FR Doc No: 2019-18924]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER11-4044-023; ER11-4046-022; ER10-2136-015; ER16-
1720-009.
    Applicants: Gratiot County Wind LLC, Gratiot County Wind II LLC,
Invenergy Cannon Falls LLC, Invenergy Energy Management LLC.
    Description: Notice of Change in Facts of Gratiot County Wind LLC,
et al.
    Filed Date: 8/27/19.
    Accession Number: 20190827-5021.
    Comments Due: 5 p.m. ET 9/17/19.

    Docket Numbers: ER19-2595-000.
    Applicants: SR Hazlehurst III, LLC.
    Description: Errata to August 13, 2019 SR Hazlehurst III, LLC
tariff filing.
    Filed Date: 8/23/19.
    Accession Number: 20190823-5181.
    Comments Due: 5 p.m. ET 9/13/19.

    Docket Numbers: ER19-2683-000.
    Applicants: EFS Parlin Holdings, LLC.
    Description: Sec.  205(d) Rate Filing: Reactive Power Rate Schedule
to be effective 8/27/2019.
    Filed Date: 8/26/19.
    Accession Number: 20190826-5156.
    Comments Due: 5 p.m. ET 9/16/19.

    Docket Numbers: ER19-2684-000.
    Applicants: Palmer Solar, LLC.
    Description: Baseline eTariff Filing: Application for Market-Based
Rate Authority to be effective 10/26/2019.
    Filed Date: 8/27/19.
    Accession Number: 20190827-5064.
    Comments Due: 5 p.m. ET 9/17/19.

    Docket Numbers: ER19-2685-000.
    Applicants: ISO New England Inc.
    Description: Sec.  205(d) Rate Filing: Ministerial Filing to
Conform Section I.2 of ISO-NE Tariff Effective 9/17/19 to be effective
9/17/2019.
    Filed Date: 8/27/19.
    Accession Number: 20190827-5081.
    Comments Due: 5 p.m. ET 9/17/19.

    Docket Numbers: ER19-2686-000.
    Applicants: California Independent System Operator Corporation.
    Description: Sec.  205(d) Rate Filing: 2019-08-27 Transferred
Frequency Response Agreement with Tucson Electric Power to be effective
12/1/2019.

    Filed Date: 8/27/19.
    Accession Number: 20190827-5093.
    Comments Due: 5 p.m. ET 9/17/19.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: August 27, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-18924 Filed 8-30-19; 8:45 am]
BILLING CODE 6717-01-P