[Federal Register Volume 82, Number 131 (Tuesday, July 11, 2017)]
[Proposed Rules]
[Page 31931]
[FR Doc No: 2017-14402]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2016-0272; FRL-9964-45-Region 5]

Air Plan Approval; Ohio; Control of Emissions of Organic
Materials That Are Not Regulated by VOC RACT Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve, under the Clean Air Act, revisions to the Ohio Administrative
Code rule as part of Ohio's State Implementation Plan (SIP). This rule
has generally been revised to: Make minor style changes to meet Ohio's
legislative service commission style and formatting guidelines; add
specific effective dates within the rule; correct certain errors and
omissions introduced when the rule was last revised; remove facilities
and units that have been permanently shut down; update the names of
certain subject facilities; and modify certain source applicability
exclusions. Sources controlled by this rule are not covered by existing
Volatile Organic Compound (VOC) Reasonably Available Control Technology
(RACT) rules or other organic material emission control rules in Ohio's
Administrative Code.

DATES: Comments must be received on or before August 10, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2016-0272, at https://www.regulations.gov, or via email to
<EMAIL_ADDRESS>For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the Web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the For Further Information Contact section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit https://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Kathleen D'Agostino, Environmental
Engineer, Attainment Planning and Maintenance Section, Air Programs
Branch (AR-18J), U.S. Environmental Protection Agency, Region 5, 77
West Jackson Boulevard, Chicago, Illinois 60604,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules section of this issue of
the Federal Register, EPA is approving Ohio's SIP revisions as a direct
final rule without prior proposal because EPA views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period. Any parties
interested in commenting on this action should do so at this time.
Please note that, if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. For
additional information, see the direct final rule, which is located in
the Rules section of this issue of the Federal Register.

    Dated: June 21, 2017.
Robert A. Kaplan,
Acting Regional Administrator, Region 5.
[FR Doc. 2017-14402 Filed 7-10-17; 8:45 am]
 BILLING CODE 6560-50-P


             Janet
             McDonald/RTP/USE
             PA/US                                                   To
<EMAIL_ADDRESS>
             04/16/2007 04:46<EMAIL_ADDRESS>
             PM                                                      cc

                                                                Subject
                                      EGU TSD

(See attached file: EGU TSD 4-12-07.doc)

 EGU TSD 4-12-071.doc


[Federal Register Volume 86, Number 96 (Thursday, May 20, 2021)]
[Notices]
[Pages 27446-27447]
[FR Doc No: 2021-10603]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5767]

Abbreviated New Drug Applications for Certain Highly Purified
Synthetic Peptide Drug Products That Refer to Listed Drugs of
Recombinant Deoxyribonucleic Acid; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled ``ANDAs for
Certain Highly Purified Synthetic Peptide Drug Products That Refer to
Listed Drugs of rDNA Origin.'' This guidance is intended to assist
potential applicants in determining when an application for a synthetic
peptide drug product that refers to a previously approved peptide drug
product of Recombinant Deoxyribonucleic Acid (rDNA) origin should be
submitted as an abbreviated new drug application (ANDA) under the
Federal Food, Drug, and Cosmetic Act (FD&C Act) rather than as a new
drug application (NDA) under the FD&C Act. This guidance finalizes the
draft guidance of the same title issued on October 3, 2017.

DATES: The announcement of the guidance is published in the Federal
Register on May 20, 2021.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2017-D-5767 for ``ANDAs for Certain Highly Purified Synthetic
Peptide Drug Products That Refer to Listed Drugs of rDNA Origin.''
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 Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your 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 https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: James Hanratty, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1672, Silver Spring, MD 20993-0002, 240-
402-4718<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``ANDAs for Certain Highly Purified Synthetic Peptide Drug
Products That Refer to Listed Drugs of rDNA Origin.'' This guidance is
intended to assist potential applicants in determining when an
application for a synthetic peptide drug product that refers to a
previously approved peptide drug product of rDNA origin should be
submitted as an ANDA under section 505(j) of the FD&C Act (21 U.S.C.
355(j)) rather than as an NDA under section 505(b) of the FD&C Act.
    This guidance finalizes the draft guidance entitled ``ANDAs for
Certain Highly Purified Synthetic Peptide Drug Products That Refer to
Listed Drugs of rDNA Origin'' issued on October 3, 2017 (82 FR 46075).
FDA considered comments received on the draft guidance as the guidance
was finalized. In addition, editorial changes were made to improve
clarity.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``ANDAs for Certain Highly Purified
Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA
Origin.'' It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521) is not required
for this guidance. The previously approved collection of information
required under 21 CFR part 314 for the submission of NDAs and ANDAs is
approved under OMB control number 0910-0001, and the submission of
controlled correspondence pertaining to ANDAs is approved under OMB
control number 0910-0797.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs or https://www.regulations.gov.

    Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10603 Filed 5-19-21; 8:45 am]
BILLING CODE 4164-01-P


North Carolina Recommendation for Rowan County The purpose of this paper is to discuss the rationale for recommending less than the entire Rowan County as nonattainment for the 8 hour ozone standard, which is part of the Charlotte/ Gastonia/ Rock Hill Metropolitan Statistical Area ( MSA). We recommend the following five small townships in the northwestern corner of the county located in 2 Census tracts containing 50 100 people per square mile not to be designated nonattainment: Cleveland, Mount Ulla, Scotch Irish, Steele, and Unity township. This MSA County has the Enochville and Rockwell monitor located in it.

  First, this area has a moderate 8 hour ozone problem, with a design value in 2001 2003 for both monitors of 0.099 ppm. Recent future year modeling results for 2007 show the DVF value of 0.090 ppm classifying this area in the marginal category.   Second, winds in Rowan County are climatologically from the southwest. With this climatological wind pattern, the county is not in an upwind sector that would routinely have an impact on air quality in the urban portion of the Charlotte/ Gastonia/ Rock Hill MSA. On the days when the two monitors exceed the 8 hour standard, it appears to be measuring the urban plume or pollution from the Charlotte. As the pollution in the Charlotte area is reduced, the monitors should observe lower ozone levels.

  Third, based on 1997 emissions inventories, Rowan County has 47.67 tons per day of NOx ( state total is 2529 tons per day) and the county has 26.70 tons per day of VOC ( state total is 1842 tons per day   anthropogenic only). In Rowan County there are some major point sources subject to control. In particular, the Buck Steam Station will have controls put on to meet both the NOx SIP Call and the Clean Smokestacks Act. The impact of the Transco Natural Gas Pumping Station ( located southwest of Rowan County) NOx emissions from neighboring Iredell County will be controlled under the NOx SIP Call and the Clean Smokestacks Act.   Fourth, another major NOx emissions source in Rowan County are mobile sources ( 16.36 tons of the 47.67 tons come from mobile sources each day, and an additional 6.03 tons per day comes from nonroad sources). The combined Federal and state control programs will address these emissions including the introduction of low sulfur gasoline statewide. In July of 2003 Rowan County began implementing an I/ M program that requires OBD testing for model year 1996 and newer cars. Expansion of this program has or will be phased in neighboring counties in this region by January 1, 2004. These counties include Catawba, Davidson, Iredell, Rowan, Lincoln, Stanley and Union.   Fifth, the population in the 5 townships North Carolina recommends to be excluded from the nonattainment area represents 7.5 percent of the total Rowan county population. The northwest corner is a rural area as indicated in the 2 Census tracts containing 50 100 people per square mile. Traffic and commuting patterns analysis show that Rowan County ranked number 7 for commuters driving into Mecklenburg County. Only 1.0 percent of all commuters are from Rowan County. Also the expected population growth for this county between 2000 and 2010 is only16.2% as compared to Mecklenburg County ( 29.3 percent).   Based on the information presented above, North Carolina continues to believe this is an appropriate boundary for this region. This site is clearly a " downwind" area from the emissions of any consequence and the Enochville and Rockwell monitors were sited at these locations to be the downwind monitor for the upwind source area that North Carolina is recommending for non attainment.


OW 2002 0021 Announcement of Regulatory Determinations for Priority Contaminants on the Drinking Water Contaminant Candidate List. Notice. July 18, 2003. Vol. 68, No. 138.

A. Federal Register Notices.

B. References Cited.

C. OMB Review Material D. Comment Response Document OW 2002 0021 II DWCCL II A A. Federal Register Notices.

1. Federal Register. U. S. Environmental Protection Agency. Regulatory Determinations for Priority Contaminants on the Drinking Water Contaminant Candidate List. Notice Vol. 68, No. 138, July 18, 2003. Pp. 42987 42906.

2. Federal Register. U. S. Environmental Protection Agency. Announcement of Preliminary Regulatory Determinations for Priority Contaminants on the Drinking Water Contaminant Candidate List. Proposed Rule. Vol. 67, No. 106, June 3, 2002. Pp. 38222 38244. ( E Dockt. OW 2002 0021 0001)

3. Federal Register. Announcement of Preliminary Regulatory Determinations for Priority Contaminants on the Drinking Water Contaminant Candidate List. Proposed Rule; Correction. Volume 67, Number 137, July 17, 2002. p. 46949. ( E Dockt. OW 2002 0021 0127) OW 2002 0021 DWCCL II  B B. References Cited.

1. ATSDR. 1993. Toxicological Profile for Aldrin/ Dieldrin ( Update). Atlanta, Georgia. U. S. Department of Health and Human Services, Public Health Service. 184 pp. ( See W 01 03, I B. 2) ( E Dockt. OW 2002 0021 0005)

2. ATSDR. 1995. Toxicological Profile for Naphthalene ( Update). Atlanta, Georgia. U. S. Department of Health and Human Services, Public Health Service. 200 pp. ( See W 01 03, I B. 4) ( E Dockt. OW 2002 0021 0004)

3. ATSDR. 2000. Toxicological Profile for Manganese ( Update). Atlanta, Georgia. U. S. Department of Health and Human Services, Public Health Service. 466 pp. and Appendices. ( See W 01 03, I B. 6) ( E Dockt. OW 2002 0021 0006)

4. USEPA. 1997. Announcement of the Draft Drinking Water Contaminant Candidate List; Notice. Federal Register. Vol. 62, No. 193, p. 52193, October 6, 1997. ( See W 01 03, I B. 23) ( E Dockt. OW 2002 0021 0020)

5. USEPA. 1998. Announcement of the Draft Drinking Water Contaminant Candidate List; Notice. Federal Register. Vol. 63, No. 40, p. 10273, March 2, 1998. ( See W 01 03, I B. 22) ( E Dockt. OW 2002 0021 0019)

6. USEPA. 2000. Methodology for Deriving Ambient Water Quality Criteria for the Protection of Human Health ( 2000). EPA 822 B 00 004. October 2000. ( E Dockt. OW 2002 0021 0130)

7. USEPA. 2001a. Regulatory Determination Support Document for Aldrin and Dieldrin. EPA 815 R 01 011. ( See W 01 03, I C. 1) ( E Dockt. OW 2002 0021 109)

8. USEPA. 2001b. Regulatory Determination Support Document for Hexachlorobutadiene. EPA 815 R 01 009. ( See W 01 03, I C. 2) ( E Dockt. OW 2002 0021 0114)

9. USEPA. 2001c. Regulatory Determination Support Document for Manganese. EPA 815 R 01 013. ( See W 01 03, I C. 3) ( E Dockt. OW 2002 0021 0115)

10. USEPA. 2001d. Regulatory Determination Support Document for Metribuzin. EPA 815 R 01 010. ( See W 01 03, I C. 4) ( E Dockt. OW 2002 0021 0116) OW 2002 0021 DWCCL II  B 11. USEPA. 2001e. Regulatory Determination Support Document for Naphthalene. EPA 815 R 01 008. ( See W 01 03, I C. 5) ( E Dockt. OW 2002 0021 0117)

12. USEPA. 2001f. Regulatory Determination Support Document for Sodium. EPA 815 R 01 014. ( See W 01 03, I C. 6) ( E Dockt. OW 2002 0021 0118)

13. USEPA. 2001g. Regulatory Determination Support Document for Sulfate. EPA 815 R 01 015. ( See W 01 03, I C. 7) ( E Dockt. OW 2002 0021 0119)

14. USEPA. 2002a. Announcement of Preliminary Regulatory Determinations for Priority Contaminants on the Drinking Water Contaminant Candidate List. Federal Register. Vol. 67, No. 106, p. 38222, June 3, 2002. ( See W 01 03, I A. 1) ( E Dockt. OW 2002 0021 0001)

15. USEPA. 2002b. Fact Sheet: Announcement of Preliminary Regulatory Determinations for Priority Contaminants on the Drinking Water Contaminant Candidate List. EPA 815 F 02 003. ( E Dockt. OW 2002 0021 0131)

16. USEPA. 2003a. Health Effects Support Document for Aldrin and Dieldrin. EPA 822 R 03 001. ( E Dockt. OW 2002 0021 0132)

17. USEPA. 2003b. Health Effects Support Document for Hexachlorobutadiene. EPA 822 R 03 002. ( E Dockt. OW 2002 0021 0133)

18. USEPA, 2003c. Health Effects Support Document for Manganese. EPA 822 R 03 003. ( E Dockt. OW 2002 0021 0134)

19. USEPA, 2003d. Health Effects Support Document for Metribuzin. EPA 822 R 03 004. ( E Dockt. OW 2002 0021 0135)

20. USEPA, 2003e. Health Effects Support Document for Naphthalene. EPA 822 R 03 005. ( E Dockt. OW 2002 0021 0136)

21. USEPA, 2003f. Drinking Water Advisory: Consumer Acceptability Advice and Health Effects Analysis on Sodium. EPA 822 R 03 006. ( E Dockt. OW 2002 0021 0137) OW 2002 0021 DWCCL II B 22. USEPA, 2003g. Drinking Water Advisory: Consumer Acceptability Advice and Health Effects Analysis on Sulfate. EPA 822 R 03 007. ( E Dockt. OW 2002 0021 0138)

23. USEPA , 2003h. Health Effects Support Document for Acanthamoeba. EPA 822 R 03 012. ( E Dockt. OW 2002 0021 0139) OW 2002 0021 DWCCL II C C. OMB Review Material 1. USEPA. Memorandum to the Record. Changes to the Notice, " Announcement of Regulatory Determinations for Priority Contaminants on the Drinking Water Contaminant Candidate List," Based on OMB Review and Comment and Other Technical Edits. July 9, 2003. 3p.

2. USEPA. 2003. Announcement of Preliminary Regulatory Determinations for Priority Contaminants on the Drinking Water Contaminant Candidate List. Revised  Red Lined Strike Out Version. 39pp.

3. Form for Compliance with E. O. 12866 Docket Requirements. OW 2002 0021 DWCCL II D D. Comment Response 1. Response to Public Comment on " Announcement of Preliminary Regulatory Determinations for Priority Contaminants on the Drinking Water Contaminant Candidate List", June 3, 2002 ( 57 FR 38222).