19530 Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Rules and Regulations 

weeks but you were born at 32 weeks 

gestation (8 weeks premature), then 

your CCA is 12 weeks. 

(2) We evaluate developmental delay 

in a premature child until the child’s 

prematurity is no longer a relevant 

factor, generally no later than about 

chronological age 2. 

(i) If you have not attained age 1 and 

were born prematurely, we will assess 

your development using your CCA. 

(ii) If you are over age 1 and have a 

developmental delay, and prematurity is 

still a relevant factor, we will decide 

whether to correct your chronological 

age. We will base our decision on our 

judgment and all the facts in your case. 

If we decide to correct your 

chronological age, we may correct it by 

subtracting the full number of weeks of 

prematurity or a lesser number of 

weeks. If your developmental delay is 

the result of your medically 

determinable impairment(s) and is not 

attributable to your prematurity, we will 

decide not to correct your chronological 

age. 

(3) Notwithstanding the provisions in 

paragraph (b)(1) of this section, we will 

not compute a CCA if the medical 

evidence shows that your treating 

source or other medical source has 

already taken your prematurity into 

consideration in his or her assessment 

of your development. We will not 

compute a CCA when we find you 

disabled under listing 100.04 of the 

Listing of Impairments. 

§ 416.926a [Amended] 

■ 5. Amend § 416.926a by removing 

paragraphs (m)(6) and (m)(7) and 

redesignating paragraph (m)(8) as (m)(6). 

■ 6. Amend § 416.934 by adding 

paragraphs (j) and (k) to read as follows: 

§ 416.934 Impairments which may warrant 

a finding of presumptive disability or 

presumptive blindness. 

* * * * * 

(j) Infants weighing less than 1200 

grams at birth, until attainment of 1 year 

of age. 

(k) Infants weighing at least 1200 but 

less than 2000 grams at birth, and who 

are small for gestational age, until 

attainment of 1 year of age. (Small for 

gestational age means a birth weight that 

is at or more than 2 standard deviations 

below the mean or that is less than the 

third growth percentile for the 

gestational age of the infant.) 

[FR Doc. 2015–08185 Filed 4–10–15; 8:45 am] 

BILLING CODE 4191–02–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

21 CFR Part 1020 

[Docket No. FDA–2015–N–0828] 

Performance Standards for Ionizing 

Radiation Emitting Products; 

Fluoroscopic Equipment; Correction 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Direct final rule. 

SUMMARY: The Food and Drug 

Administration (FDA) is amending a 

Federal performance standard for 

ionizing radiation to correct a drafting 

error regarding fluoroscopic equipment 

measurement. We are taking this action 

to ensure clarity and improve the 

accuracy of the regulations. 

DATES: This rule is effective August 26, 

2015. Submit electronic or written 

comments on this direct final rule or its 

companion proposed rule by June 29, 

2015. 

ADDRESSES: You may submit comments 

by any of the following methods: 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

Written Submissions 

Submit written comments in the 

following ways: 

• Mail/Hand delivery/Courier (for 

paper submissions): Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. 

Instructions: All submissions received 

must include the Docket No. FDA– 

2015–N–0828 for this rulemaking. All 

comments received may be posted 

without change to http://

www.regulations.gov, including any 

personal information provided. For 

additional information on submitting 

comments, see the ‘‘Comments’’ heading 

of the SUPPLEMENTARY INFORMATION

section of this document. 

Docket: For access to the docket to 

read background documents or 

comments received, go to http://

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: 

Scott Gonzalez, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, Rm. 4641, Silver Spring, 

MD 20993–0002, 301–796–5889. 

SUPPLEMENTARY INFORMATION: 

I. What is the background of this Rule? 

FDA is correcting a drafting error 

regarding fluoroscopic equipment 

measurement in § 1020.32 (21 CFR 

1020.32). We are publishing this direct 

final rule because it is intended to make 

a noncontroversial amendment to 

§ 1020.32, and we do not anticipate any 

significant adverse comments. 

Specifically, this amendment changes 

the words ‘‘any linear dimension’’ in the 

current regulation to read ‘‘every linear 

dimension’’ (§ 1020.32(b)(4)(ii)(A)). The 

alternative performance standard, 

§ 1020.32(b)(4)(ii)(B), currently contains 

the same phrase but remains 

unchanged. We are amending the 

language to make the performance 

standards mutually exclusive. This will 

ensure clarity and improve the accuracy 

of the regulations. 

FDA first proposed the performance 

standards in the Federal Register of 

December 10, 2002 (67 FR 76056), to 

account for technological changes in 

fluoroscopic equipment. The proposed 

rule did not specify which measurement 

of the visible area of an image receptor 

determined the applicable performance 

standard (67 FR 76056 at 76092). When 

we addressed comments to the proposed 

rule in the Federal Register of June 10, 

2005, we agreed with one comment that 

adding the words ‘‘any linear 

dimension’’ would clarify the 

determination of the performance 

standard (70 FR 33998 at 34007). 

FDA ultimately incorporated the 

phrase in two places, potentially 

reducing the clarity of the rule (70 FR 

33998 at 34040). Section 

1020.32(b)(4)(ii) sets performance 

standards based on a threshold, so the 

language for each standard should be 

mutually exclusive. That is, only one 

standard, and not the other, should 

apply to the image receptor in question. 

However, some image receptors may 

have linear dimensions that are both 

greater than and less than 34 cm, for 

example, receptors with a hexagonal 

shape. In such cases, the performance 

standards may not be mutually 

exclusive, so both standards may appear 

to apply. This direct final rule amends 

§ 1020.32(b)(4)(ii)(A) to read ‘‘every 

linear dimension’’ to ensure the 

standards are mutually exclusive. The 

amendment will improve the clarity and 

accuracy of the regulations. 


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Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Rules and Regulations 19531 

II. What are the procedures for issuing 

a direct Final Rule? 

In the Federal Register of November 

21, 1997 (62 FR 62466), FDA announced 

the availability of the guidance 

document entitled ‘‘Guidance for FDA 

and Industry: Direct Final Rule 

Procedures’’ that described when and 

how we will employ direct final 

rulemaking. We believe that this rule is 

appropriate for direct final rulemaking 

because it is intended to make a 

noncontroversial amendment for a 

minor correction to an existing 

regulation. We anticipate no significant 

adverse comments. 

Consistent with FDA’s procedures on 

direct final rulemaking, we are 

publishing a companion proposed rule 

elsewhere in this issue of the Federal 

Register. That proposed rule is identical 

in substance to this direct final rule. The 

companion proposal will provide a 

procedural framework to finalize a new 

rule in the event we withdraw this 

direct final rule because we receive 

significant adverse comment. The 

comment period for this direct final rule 

runs concurrently with the comment 

period of the companion proposed rule. 

We will consider any comments that we 

receive in response to the companion 

proposed rule to be comments also 

regarding this direct final rule and vice 

versa. 

If FDA receives any significant 

adverse comments, we will withdraw 

this direct final rule before its effective 

date by publishing a notice in the 

Federal Register within 30 days after 

the comment period ends. A significant 

adverse comment is one that explains 

why the rule would be inappropriate 

(including challenges to the rule’s 

underlying premise or approach), 

ineffective, or unacceptable without 

change. In determining whether an 

adverse comment is significant and 

warrants withdrawing a direct final rule, 

we consider whether the comment 

raises an issue serious enough to 

warrant a substantive response in a 

notice-and-comment process in 

accordance with section 553 of the 

Administrative Procedure Act (APA) (5 

U.S.C. 553). Comments that are 

frivolous, insubstantial, or outside the 

scope of the rule will not be considered 

a significant adverse comment, unless 

the comment states why the rule would 

be ineffective without the additional 

change. In addition, if a significant 

adverse comment applies to part of a 

rule and that part can be severed from 

the remainder of the rule, we may adopt 

as final those parts of the rule that are 

not the subject of a significant adverse 

comment. 

If we withdraw this direct final rule, 

FDA will consider all comments that we 

received regarding the companion 

proposed rule as we develop a final rule 

through the usual notice-and-comment 

procedures of the APA (5 U.S.C. 552a, 

et seq.). If we receive no significant 

adverse comments during the specified 

comment period regarding this direct 

final rule, we intend to publish a 

confirmation document in the Federal 

Register within 30 days after the 

comment period ends. 

III. What is the legal authority for this 

Rule? 

This rule, if finalized, would amend 

§ 1020.32. FDA’s authority to modify 

§ 1020.32 arises from the same authority 

under which FDA initially issued this 

regulation, the device and general 

administrative provisions of the Federal 

Food, Drug, and Cosmetic Act (21 U.S.C. 

351, 352, 360e–360j, 360hh–360ss, 371, 

and 381). 

IV. What is the environmental impact 

of this Rule? 

FDA has determined under 21 CFR 

25.30(h) and 25.34(a) that this action is 

of a type that does not individually or 

cumulatively have a significant effect on 

the human environment. Therefore, 

neither an environmental assessment 

nor an environmental impact statement 

is required. 

V. What is the economic analysis of 

impact of this Rule? 

FDA has examined the impacts of the 

final rule under Executive Order 12866, 

Executive Order 13563, the Regulatory 

Flexibility Act (5 U.S.C. 601–612), and 

the Unfunded Mandates Reform Act of 

1995 (Pub. L. 104–4). Executive Orders 

12866 and 13563 direct Agencies to 

assess all costs and benefits of available 

regulatory alternatives and, when 

regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety, and other advantages; 

distributive impacts; and equity). The 

Agency believes that this final rule is 

not a significant regulatory action under 

Executive Order 12866. 

The Regulatory Flexibility Act 

requires Agencies to analyze regulatory 

options that would minimize any 

significant impact of a rule on small 

entities. Because this rule does not add 

any additional regulatory burdens, the 

Agency certifies that this final rule will 

not have a significant economic impact 

on a substantial number of small 

entities. 

Section 202(a) of the Unfunded 

Mandates Reform Act of 1995 requires 

that Agencies prepare a written 

statement, which includes an 

assessment of anticipated costs and 

benefits, before proposing ‘‘any rule that 

includes any Federal mandate that may 

result in the expenditure by State, local, 

and tribal governments, in the aggregate, 

or by the private sector, of $100,000,000 

or more (adjusted annually for inflation) 

in any one year.’’ The current threshold 

after adjustment for inflation is $141 

million, using the most current (2013) 

Implicit Price Deflator for the Gross 

Domestic Product. This final rule would 

not result in a 1-year expenditure that 

meets or exceeds this amount. 

The purpose of this final rule is to 

correct a drafting error regarding 

fluoroscopic equipment measurement in 

a performance standard for ionizing 

radiation. The amendment will improve 

the clarity and accuracy of the 

regulations. Because this final rule is a 

technical correction and would impose 

no additional regulatory burdens, this 

regulation is not anticipated to result in 

any compliance costs, and the economic 

impact is expected to be minimal. 

VI. How does the Paperwork Reduction 

Act of 1995 apply to this Rule? 

This final rule contains no collection 

of information. Therefore, clearance by 

the Office of Management and Budget 

under the Paperwork Reduction Act of 

1995 is not required. 

VII. What are the Federalism 

implications of this Rule? 

FDA has analyzed this final rule in 

accordance with the principles set forth 

in Executive Order 13132. FDA has 

determined that the rule does not 

contain policies that have substantial 

direct effects on the States, on the 

relationship between the National 

Government and the States, or on the 

distribution of power and 

responsibilities among the various 

levels of government. Accordingly, the 

Agency has concluded that the rule does 

not contain policies that have 

federalism implications as defined in 

the Executive order and, consequently, 

a federalism summary impact statement 

is not required. 

VIII. How do you submit comments on 

this Rule? 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 


wreier-aviles on DSK5TPTVN1PROD with RULES
19532 Federal Register / Vol. 80, No. 70 / Monday, April 13, 2015 / Rules and Regulations 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

List of Subjects in 21 CFR Part 1020 

Electronic products, Medical devices, 

Radiation protection, Reporting and 

recordkeeping requirements, Television, 

X-rays. 

Therefore, under the Federal Food, 

Drug, and Cosmetic Act and under 

authority delegated to the Commissioner 

of Food and Drugs, 21 CFR part 1020 is 

amended as follows: 

PART 1020—PERFORMANCE 

STANDARDS FOR IONIZING 

RADIATION EMITTING PRODUCTS 

■ 1. The authority citation for 21 CFR 

part 1020 continues to read as follows: 

Authority: 21 U.S.C. 351, 352, 360e–360j, 

360hh–360ss, 371, 381. 

■ 2. Revise § 1020.32(b)(4)(ii)(A) to read 

as follows: 

§ 1020.32 Fluoroscopic equipment. 

(b) * * * 

(4) * * * 

(ii) * * * 

(A) When every linear dimension of 

the visible area of the image receptor 

measured through the center of the 

visible area is less than or equal to 34 

cm in any direction, at least 80 percent 

of the area of the x-ray field overlaps the 

visible area of the image. 

* * * * * 

Dated: April 7, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–08360 Filed 4–10–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF THE TREASURY 

Office of Foreign Assets Control 

31 CFR Part 542 

Syrian Sanctions Regulations 

AGENCY: Office of Foreign Assets 

Control, Treasury. 

ACTION: Final rule. 

SUMMARY: The Department of the 

Treasury’s Office of Foreign Assets 

Control is amending the Syrian 

Sanctions Regulations to authorize by 

general license certain activities relating 

to publishing, not already exempt from 

regulation, that support the publishing 

and marketing of manuscripts, books, 

journals, and newspapers in paper and 

electronic format. 

DATES: Effective: April 13, 2015. 

FOR FURTHER INFORMATION CONTACT: 

Assistant Director for Licensing, tel.: 

202/622–2480, Assistant Director for 

Policy, tel.: 202/622–6746, Assistant 

Director for Regulatory Affairs, tel: 202/ 

622–4855, Assistant Director for 

Sanctions Compliance & Evaluation, 

tel.: 202/622–2490, Office of Foreign 

Assets Control, or Chief Counsel 

(Foreign Assets Control), tel.: 202/622– 

2410, Office of the General Counsel, 

Department of the Treasury (not toll free 

numbers). 

SUPPLEMENTARY INFORMATION: 

Electronic and Facsimile Availability 

This document and additional 

information concerning OFAC are 

available from OFAC’s Web site 

(www.treasury.gov/ofac). Certain general 

information pertaining to OFAC’s 

sanctions programs also is available via 

facsimile through a 24-hour fax-ondemand service, tel.: 202/622–0077. 

Background 

On April 5, 2005, the Office of 

Foreign Assets Control (OFAC) issued 

the Syrian Sanctions Regulations, 31 

CFR part 542 (the ‘‘Regulations’’) (70 FR 

17201, April 5, 2005), to implement 

Executive Order 13338 of May 11, 2004 

(69 FR 26751, May 13, 2004) (E.O. 

13338), pursuant to, inter alia, the 

International Emergency Economic 

Powers Act (50 U.S.C. 1701 et seq.) 

(IEEPA). On May 2, 2014, OFAC 

amended the Regulations to implement 

Executive Order 13399 of April 25, 2006 

(71 FR 25059, April 28, 2006) (E.O. 

13399), Executive Order 13460 of 

February 13, 2008 (73 FR 8991, 

February 15, 2008) (E.O. 13460), 

Executive Order 13572 of April 29, 2011 

(76 FR 24787, May 3, 2011) (E.O. 

13572), Executive Order 13573 of May 

18, 2011 (76 FR 29143, May 20, 2011) 

(E.O. 13573), Executive Order 13582 of 

August 17, 2011 (76 FR 52209, August 

22, 2011) (E.O. 13582), and Executive 

Order 13606 of April 22, 2012 (77 FR 

24571, April 24, 2012) (E.O. 13606). 

Today, OFAC is amending the 

Regulations to authorize certain 

activities relating to publishing. 

With certain exceptions, the 

exportation or importation of 

information or informational materials 

to or from any country is exempt from 

regulation by the President under 

IEEPA. See 50 U.S.C. 1702(b)(3); 31 CFR 

542.211(b). OFAC is issuing a new 

general license set forth at 31 CFR 

542.532 to authorize, subject to certain 

limitations, transactions not already 

exempt from regulation that support the 

publishing and marketing of 

manuscripts, books, journals, and 

newspapers, in paper or electronic 

format. 

Public Participation 

Because the amendment of the 

Regulations involves a foreign affairs 

function, Executive Order 12866 and the 

provisions of the Administrative 

Procedure Act (5 U.S.C. 553) requiring 

notice of proposed rulemaking, 

opportunity for public participation, 

and delay in effective date are 

inapplicable. Because no notice of 

proposed rulemaking is required for this 

rule, the Regulatory Flexibility Act (5 

U.S.C. 601–612) does not apply. 

Paperwork Reduction Act 

The collections of information related 

to the Regulations are contained in 31 

CFR part 501 (the ‘‘Reporting, 

Procedures and Penalties Regulations’’). 

Pursuant to the Paperwork Reduction 

Act of 1995 (44 U.S.C. 3507), those 

collections of information have been 

approved by the Office of Management 

and Budget under control number 1505– 

0164. An agency may not conduct or 

sponsor, and a person is not required to 

respond to, a collection of information 

unless the collection of information 

displays a valid control number. 

List of Subjects in 31 CFR Part 542 

Administrative practice and 

procedure, Exports, Foreign trade, 

Information, Services, Syria. 

For the reasons set forth in the 

preamble, the Department of the 

Treasury’s Office of Foreign Assets 

Control amends 31 CFR part 542 as set 

forth below: 

PART 542—SYRIAN SANCTIONS 

REGULATIONS 

■ 1. The authority citation for part 542 

continues to read as follows: 

Authority: 3 U.S.C. 301; 31 U.S.C. 321(b); 

18 U.S.C. 2332d; 22 U.S.C. 287c; 50 U.S.C. 

1601–1651, 1701–1706; Pub. L. 101–410, 104 

Stat. 890 (28 U.S.C. 2461 note); Pub. L. 110– 

96, 121 Stat. 1011 (50 U.S.C. 1701 note); E.O. 

13338, 69 FR 26751, 3 CFR, 2004 Comp., p. 

168; E.O. 13399, 71 FR 25059, 3 CFR, 2006 

Comp., p. 218; E.O. 13460, 73 FR 8991, 3 CFR 

2008 Comp., p. 181; E.O. 13572, 76 FR 24787, 

3 CFR 2011 Comp., p.236; E.O. 13573, 76 FR 

29143, 3 CFR 2011 Comp., p. 241; E.O. 

13582, 76 FR 52209, 3 CFR 2011 Comp., p. 

264; E.O. 13606, 77 FR 24571, 3 CFR 2012 

Comp., p.243. 

Subpart E—Licenses, Authorizations, 

and Statements of Licensing Policy 

■ 2. Add new § 542.532 to read as 

follows: 


wreier-aviles on DSK5TPTVN1PROD with RULES