Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules 10637 

Environmental Policy Act of 1969 

(NEPA) (42 U.S.C. 4321–4370f), and 

have made a preliminary determination 

that this action is one of a category of 

actions that do not individually or 

cumulatively have a significant effect on 

the human environment. This proposed 

rule involves waterway use restrictions 

that would be otherwise published as a 

Temporary Final Rule within the 

Savannah Captain of the Port Zone. This 

rule is categorically excluded from 

further review under paragraph 34(g) of 

Figure 2–1 of the Commandant 

Instruction. A preliminary 

environmental analysis checklist 

supporting this determination and a 

Categorical Exclusion Determination are 

available in the docket where indicated 

under ADDRESSES. We seek any 

comments or information that may lead 

to the discovery of a significant 

environmental impact from this 

proposed rule. 

List of Subjects in 33 CFR Part 165 

Harbors, Marine safety, Navigation 

(water), Reporting and recordkeeping 

requirements, Security measures, 

Waterways. 

For the reasons discussed in the 

preamble, the Coast Guard proposes to 

amend 33 CFR part 165 as follows: 

PART 165—REGULATED NAVIGATION 

AREAS AND LIMITED ACCESS AREAS 

■ 1. The authority citation for part 165 

continues to read as follows: 

Authority: 33 U.S.C. 1231; 46 U.S.C. 

Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 

33 CFR 1.05–1, 6.04–1, 6.04–6, 160.5; Pub. L. 

107–295, 116 Stat. 2064; Department of 

Homeland Security Delegation No. 0170.1. 

■ 2. Add § 165.732 to read as follows: 

§ 165.732 Safety Zone; Marine Safety Unit 

Savannah Safety Zone for Heavy Weather 

and other Natural Disasters, Savannah 

Captain of the Port Zone, Savannah, GA. 

(a) Regulated Areas. The following 

areas are established as safety zones 

during the specified conditions: 

(1) Savannah, GA. All waters within 

the Port of Savannah, GA, encompassed 

within following locations: starting at 

the demarcation line drawn across the 

seaward extremity of the Savannah 

River entrance, and encompassing all of 

the waters of the Savannah River, 

Savannah GA. 

(2) Brunswick, GA. All waters starting 

at the demarcation line drawn across the 

seaward extremity of the Savannah 

River entrance, and encompassing all of 

the waters of the Brunswick River, 

Brunswick GA. 

(3) All coordinates are North 

American Datum 1983. 

(b) Definition. 

(1) The term ‘‘designated 

representative’’ means Coast Guard 

Patrol Commanders, including Coast 

Guard coxswains, petty officers, and 

other officers operating Coast Guard 

vessels, and Federal, state, and local 

officers designated by or assisting the 

Captain of the Port Savannah in the 

enforcement of the regulated area. 

(2) Hurricane Port Condition 

YANKEE. Set when weather advisories 

indicate that sustained Gale Force 

winds from a tropical or hurricane force 

storm are predicted to make landfall at 

the port within 24 hours. 

(3) Hurricane Port Condition ZULU. 

Set when weather advisories indicate 

that sustained Gale Force winds from a 

tropical or hurricane force storm are 

predicted to make landfall at the port 

within 12 hours. 

(c) Regulations. 

(1) Hurricane Port Condition 

YANKEE. All commercial, oceangoing 

vessels and barges over 500 gross tons 

are prohibited from entering the 

regulated areas designated as being in 

Port Condition YANKEE; within 24 

hours of anticipated landfall of gale 

force winds (39mph) from tropical or 

hurricane force storm; or upon the Coast 

Guard setting Port Condition YANKEE 

for inbound ocean going commercial 

vessel traffic over 500 GT. Oceangoing 

commercial vessel traffic outbound will 

be authorized to transit through the 

regulated areas until Port Condition 

ZULU. 

(2) Hurricane Port Condition ZULU. 

All commercial, oceangoing vessels and 

barges over 500 gross tons are 

prohibited from entering the regulated 

areas designated as being in Port 

Condition ZULU; within 12 hours of 

anticipated landfall of a tropical storm 

or hurricane; or upon the Coast Guard 

setting Port Condition ZULU, unless 

written permission is obtained from the 

Captain of the Port. All ship-to-shore 

cargo operations must cease six hours 

prior to setting Port Condition Zulu. 

(3) Emergency Waterway Restriction 

for Other Disasters. Any natural or other 

disasters that are anticipated to affect 

the Captain of the Port Savannah area of 

responsibility will result in the 

prohibition of commercial vessel traffic 

transiting or remaining in any of the two 

regulated areas predicted to be affected 

as designated by the Captain of the Port 

Savannah. 

(4) Persons and vessels desiring to 

enter, transit through, anchor in, or 

remain in the regulated area may 

contact the Captain of the Port 

Savannah via telephone at (912) 247– 

0073, or a designated representative via 

VHF radio on channel 16, to request 

authorization. If authorization to enter, 

transit through, anchor in, or remain in 

the regulated area is granted by the 

Captain of the Port Savannah or a 

designated representative, all persons 

and vessels receiving such authorization 

must comply with the instructions of 

the Captain of the Port Savannah or a 

designated representative. 

(5) Coast Guard Marine Safety Unit 

Savannah will attempt to notify the 

maritime community of periods during 

which these safety zones will be in 

effect via Broadcast Notice to Mariners 

or by on-scene designated 

representatives. 

(6) The Coast Guard will provide 

notice of the regulated area via 

Broadcast Notice to Mariners or by onscene designated representatives. 

(7) This regulation does not apply to 

authorized law enforcement agencies 

operating within the regulated area. 

Dated: February 2, 2015. 

A.M. Beach, 

Commander, U.S. Coast Guard, Captain of 

the Port Savannah. 

[FR Doc. 2015–04163 Filed 2–26–15; 8:45 am] 

BILLING CODE 9110–04–P 

DEPARTMENT OF VETERANS 

AFFAIRS 

38 CFR Part 4 

RIN 2900–AP13 

Schedule for Rating Disabilities; 

Gynecological Conditions and 

Disorders of the Breast 

AGENCY: Department of Veterans Affairs. 

ACTION: Proposed rule. 

SUMMARY: The Department of Veterans 

Affairs (VA) proposes to amend the 

portion of the VA Schedule for Rating 

Disabilities (VASRD or rating schedule) 

that addresses gynecological conditions 

and disorders of the breast. The purpose 

of these changes is to incorporate 

medical advances that have occurred 

since the last review, update current 

medical terminology, and provide clear 

evaluation criteria. The proposed rule 

reflects advances in medical knowledge, 

recommendations from the 

Gynecological Conditions and Disorders 

of the Breast Work Group (Work Group), 

which is comprised of subject matter 

experts from both the Veterans Benefits 

Administration (VBA) and the Veterans 

Health Administration (VHA), and 

comments from experts and the public 

gathered as part of a public forum. The 

public forum, focusing on revisions to 

the gynecological conditions and 

disorders of the breast section of the 

VASRD, was held on January 24, 2012. 


tkelley on DSK3SPTVN1PROD with PROPOSALS
10638 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules 

DATES: Comments must be received on 

or before April 28, 2015. 

ADDRESSES: Written comments may be 

submitted through 

www.Regulations.gov; by mail or handdelivery to Director, Regulation Policy 

and Management (02REG), Department 

of Veterans Affairs, 810 Vermont 

Avenue NW., Room 1068, Washington, 

DC 20420; or by fax to (202) 273–9026. 

Comments should indicate that they are 

submitted in response to ‘‘RIN 2900– 

AP13—Schedule for Rating Disabilities; 

Gynecological Conditions and Disorders 

of the Breast.’’ Copies of comments 

received will be available for public 

inspection in the Office of Regulation 

Policy and Management, Room 1068, 

between the hours of 8:00 a.m. and 4:30 

p.m., Monday through Friday (except 

holidays). Please call (202) 461–4902 for 

an appointment. (This is not a toll-free 

number.) In addition, during the 

comment period, comments may be 

viewed online through the Federal 

Docket Management System (FDMS) at 

www.Regulations.gov. 

FOR FURTHER INFORMATION CONTACT: 

Ioulia Vvedenskaya, Medical Officer, 

Part 4 VASRD Regulations Staff (211C), 

Compensation Service, Veterans 

Benefits Administration, Department of 

Veterans Affairs, 810 Vermont Avenue 

NW., Washington, DC 20420, (202) 461– 

9700. (This is not a toll-free telephone 

number.) 

SUPPLEMENTARY INFORMATION: As part of 

VA’s ongoing revision of the VA 

Schedule for Rating Disabilities (VASRD 

or rating schedule), VA proposes 

changes to 38 CFR 4.116, which pertains 

to gynecological conditions and 

disorders of the breast. The proposed 

changes will: (1) Update the medical 

terminology of certain gynecological 

conditions and disorders of the breast, 

(2) add medical conditions not currently 

in the rating schedule, and (3) refine 

evaluation criteria based on medical 

advances that have occurred since the 

last revision and current understanding 

of functional changes associated with or 

resulting from disease or injury 

(pathophysiology). 

Schedule of Ratings—Gynecological 

Conditions and Disorders of the Breast 

Section 4.116 currently lists 19 

diagnostic codes encompassing 

conditions involving injury or disease of 

female reproductive organs and of the 

breast. VA proposes to revise these 

codes, through addition, removal, or 

other revisions, to reflect current 

medical science and terminology, and 

functional impairment. 

Diagnostic Code 7610 ‘‘Vulva, disease 

or injury of (including vulvovaginitis)’’ 

Current diagnostic code 7610 

addresses impairments associated with 

disease or injury of the vulva. The vulva 

refers to the exterior anatomical portion 

of the female genitalia and includes the 

clitoris. ‘‘Vulva,’’ Mayo Clinic, http://

www.mayoclinic.org/vulva/img20005974 (last visited June 20, 2014). To 

provide clarity as to the applicability of 

this diagnostic code and to promote 

consistent and adequate evaluations, VA 

proposes to update the title of this 

diagnostic code to specifically include 

injury or disease of the clitoris, in 

addition to the vulva. 

Diagnostic Code 7615 ‘‘Ovary, disease, 

injury, or adhesions of’’ 

Current diagnostic code 7615 

addresses impairments associated with 

disease, injury or adhesions of the 

ovaries. VA proposes to place a note 

under diagnostic code 7615 to identify 

two common diseases associated with 

ovarian dysfunction resulting in 

abnormal menstrual cycles: 

Dysmenorrhea and secondary 

amenorrhea. Dysmenorrhea is pain 

associated with menstruation and is the 

most commonly reported menstrual 

disorder. ‘‘Dysmenorrhea,’’ American 

College of Obstetricians and 

Gynecologists (July 2012), http://

www.acog.org/∼/media/For%20Patients

/faq046.pdf?dmc

=1&ts=20130904T1049007771 (last 

visited Jan. 21, 2014). Secondary 

amenorrhea occurs when a woman who 

has been having normal menstrual 

cycles stops menstruating for 6 or more 

months. Tarannum Master-Hunter & 

Diana L. Heiman, ‘‘Amenorrhea: 

Evaluation and Treatment,’’ 73 

American Family Physician 1374, 1374– 

82 (2006). The proposed note will state 

that for the purpose of disability 

evaluation, a disease, injury, or 

adhesions of the ovaries resulting in 

ovarian dysfunction affecting the 

menstrual cycle, such as dysmenorrhea 

and secondary amenorrhea, shall be 

rated under diagnostic code 7615. 

Diagnostic Code 7619 ‘‘Ovary, removal 

of’’ 

Diagnostic code 7619, ‘‘Ovary, 

removal of,’’ addresses impairment 

associated with complete and partial 

removal of the ovaries. Serviceconnected complete removal of both 

ovaries is currently evaluated at 100 

percent for the three months following 

removal and then 30 percent thereafter. 

With the continued expansion of 

women’s roles in military service, better 

understanding of the health effects on 

women during and after service is 

essential. Women who suffer premature 

loss of function in both ovaries are at 

increased risk for cardiovascular 

disease, stroke, lung cancer, cognitive 

impairment or dementia, Parkinsonism, 

osteoporosis, depressive or anxiety 

symptoms, and sexual dysfunction. The 

risks appear to be greater for women 

who are younger at the time of 

premature loss of ovarian function. 

Studies have shown that even women 

who have both ovaries removed ‘‘after 

the onset of natural menopause had an 

increased risk of deleterious outcomes.’’ 

Lynne T. Shuster et al., ‘‘Prophylactic 

bilateral oophorectomy jeopardizes 

long-term health,’’ 18(4), American 

Society for Reproductive Medicine, 

Menopausal Medicine S1, S1–S5 (2010). 

Currently, a male Veteran is entitled 

to a 30 percent evaluation for serviceconnected removal of one testicle when 

the second testicle, for reasons 

unrelated to service, is absent or ceases 

to function. 38 CFR 4.115b, Diagnostic 

Code 7524, Note. However, the current 

VASRD does not provide a similar 

evaluation for a female Veteran whose 

second ovary is absent or ceases to 

function for reasons unrelated to 

service. With consideration of the 

studies discussed above demonstrating 

the significant health risks from removal 

or loss of function of both ovaries, VA 

proposes to add a note to diagnostic 

code 7619 in order to equalize VA 

compensation for female Veterans. 

Diagnostic Codes 7621 ‘‘Uterus, 

prolapse,’’ 7622 ‘‘Uterus, displacement 

of,’’ and 7623 ‘‘Pregnancy, surgical 

complications of ’’ 

Current diagnostic codes 7621 

through 7623 address impairment 

associated with various degrees of 

female pelvic organ prolapse. Uterine 

prolapse is evaluated under current 

diagnostic code 7621, as either (1) 

complete uterine prolapse through the 

vagina and introitus at 50 percent, or (2) 

incomplete uterine prolapse at 30 

percent. Uterine displacement is 

evaluated under current diagnostic code 

7622, as either (1) marked uterine 

displacement and frequent or 

continuous menstrual disturbances at 30 

percent, or (2) uterine displacement 

with adhesions and irregular 

menstruation at 10 percent. Finally, 

surgical complications of pregnancy are 

evaluated under current diagnostic code 

7623, as either (1) with rectocele or 

cystocele at 50 percent, or (2) with 

relaxation of perineum at 10 percent. 

To update VASRD, VA proposes to 

consolidate these three diagnostic codes 

into one diagnostic code. Specifically, 

VA proposes to amend diagnostic code 


tkelley on DSK3SPTVN1PROD with PROPOSALS
Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules 10639 

7621 to be titled, ‘‘Pelvic organ prolapse 

due to injury, disease, or surgical 

complications of pregnancy.’’ VA 

proposes this consolidation because all 

of these diagnostic codes represent 

different types of pelvic organ prolapse 

(displacement) and describe various 

degrees of their displacement to or 

beyond the vaginal walls. Furthermore, 

as discussed in more detail below, 

current medicine has a reliable 

classification system that provides for 

uniform evaluation of functional 

impairment due to pelvic organ 

prolapse (displacement), regardless of 

which pelvic organ is involved. 

Therefore, combining the evaluations 

currently found in diagnostic codes 

7621 through 7623 would better reflect 

the current understanding of anatomy, 

physiology, and functional impairment 

due to disease or injury of pelvic organs. 

VA also proposes to place a note under 

diagnostic code 7621 that will describe 

pelvic organ prolapse and identify 

common types of prolapse, including 

uterine or vaginal vault prolapse, 

cystocele, urethrocele, rectocele, 

enterocele, or any combination. This 

note would assist field personnel in 

selecting the appropriate diagnostic 

code for these diagnosed conditions. 

Currently, diagnostic codes 7621 and 

7622 address uterine prolapse and 

uterine displacement, respectively; 

however, uterine displacement is just an 

outdated reference to uterine prolapse. 

Therefore, separate diagnostic codes are 

redundant and unnecessary. As for 

diagnostic code 7623, it provides for 

evaluation of pelvic organ displacement 

such as rectocele, cystocele, and 

relaxation of perineum when due to 

surgical complications of pregnancy. 

However, all of these pelvic organ 

displacements can occur independently 

from surgical complications of 

pregnancy. Therefore, an update to 

VASRD is needed to account for these 

situations. 

This proposed revision is also 

necessary to eliminate disparate 

treatment of pelvic organ displacement 

found in the current VASRD. In this 

regard, rectocele or cystocele are rated 

under current diagnostic code 7623 

without regard to the severity of the 

displacement (and, in turn, the 

symptoms associated with the 

displacement), whereas uterine prolapse 

and displacement (rated under 

diagnostic codes 7621 and 7622) are 

evaluated based on the degree of 

displacement. 

Pelvic organs, such as the uterus, 

bladder or bowel, may protrude into the 

vagina due to weakness in the tissues 

that normally support them. In the most 

severe cases, part or all of the uterus or 

vagina can protrude beyond the vaginal 

opening (introitus). Pelvic organ 

prolapse includes anterior vaginal wall 

prolapse (cystocele, urethrocele), 

posterior vaginal wall prolapse 

(enterocele, rectocele, perineal 

deficiency) and uterine or vaginal vault 

prolapse. A woman can present with 

prolapse of one or more of these sites. 

Christopher Maher et al., ‘‘Surgical 

management of pelvic organ prolapse in 

women,’’ Cochrane Database of 

Systematic Reviews (2010), http://

onlinelibrary.wiley.com/doi/10.1002/

14651858.CD004014.pub4/abstract (last 

accessed Jan. 21, 2014). A woman’s 

symptoms are largely based on the 

severity of her prolapse. Women with 

mild cases of uterine prolapse may have 

no obvious symptoms or require no 

active intervention. However, as the 

uterus slips further out of normal 

position, it can place pressure on other 

pelvic organs (such as the bladder or 

bowel) causing a variety of symptoms 

such as a feeling of heaviness or 

pressure in the pelvis, pelvic pain, 

abdomen or lower back pain, pain 

during intercourse, a protrusion of 

tissue from the opening of the vagina, 

recurrent bladder infections, 

constipation, difficulty with urination 

or urinary frequency or urgency. G. 

Willy Davila et al., ‘‘Vaginal Vault 

Suspension’’ (updated Sept. 6, 2013), 

Medscape, http://

emedicine.medscape.com/article/

1848619-overview#aw2aab6b9 (last 

accessed Jan. 21, 2014). Therefore, it is 

essential to identify the severity of any 

pelvic organ prolapse in order to 

determine the level of functional 

impairment. 

To ensure consistent evaluation of 

pelvic organ prolapse, VA proposes to 

base its rating criteria on the pelvic 

organ prolapse (POP) classification 

system. POP presents the herniation of 

the pelvic organs to or beyond the 

vaginal opening (at the level of the 

hymen) and is described using the 

findings during pelvic examination. 

‘‘Pelvic Organ Prolapse,’’ American 

College of Obstetricians and 

Gynecologists Practice Bulletin, Vol. 

110, No. 3 (Sept. 2007). The severity of 

prolapse is graded using the standard 

Pelvic Organ Prolapse Quantification 

(POP–Q) classification system. The 

POP–Q examination is an objective, sitespecific system that is used to quantify, 

describe, and stage pelvic support. The 

POP–Q system has proven interobserver 

and intraobserver reliability. A.F. Hall et 

al., ‘‘Interobserver and intraobserver 

reliability of the proposed International 

Continence Society, Society of 

Gynecologic Surgeons, and American 

Urogynecologic Society pelvic organ 

prolapse classification system,’’ 175 Am 

J Obstet Gynecol 1467, 1467–70 (1996). 

As for the functional impairment 

associated with each stage of severity, 

VA proposes to assign a 50 percent 

evaluation in cases of severe pelvic 

organ prolapse, where on examination 

complete or almost complete eversion of 

the total length of the vagina is present, 

and the length of the protrusion beyond 

the hymen is within 2 centimeters of the 

total vaginal length. VA proposes to 

assign a 30 percent evaluation in cases 

of moderate prolapse, where on 

examination, the most severe portion of 

the prolapse is more than 1 centimeter 

below the hymen, but no further than 2 

cm less than the total vaginal length. 

Finally, VA proposes to assign a 10 

percent evaluation in cases of mild 

prolapse, where on examination, the 

most severe portion of the prolapse is 

between 1 cm or less above and 1 cm 

or more below the hymen. 

VA also proposes to eliminate 

references to frequent or continuous 

menstrual disturbances, adhesions, and 

irregular menstruation as a measure of 

the degree of uterine displacement, 

because the symptoms noted are either 

outdated or adequately contemplated by 

the POP–Q system. For example, uterine 

displacement, also known as uterine 

prolapse, occurs when pelvic floor 

muscles and ligaments stretch and 

weaken and the uterus slips down into 

or protrudes out of the vagina. Minimal 

uterine prolapse generally does not 

require therapy or cause any 

impairment because the patient usually 

does not have any symptoms. However, 

uterine descent of the cervix at or 

through the vaginal opening (introitus) 

can become symptomatic. Symptoms of 

moderate and severe uterine prolapse 

include a sensation of vaginal fullness 

or pressure, back pain, vaginal spotting 

from ulceration of the protruding cervix 

or vagina, difficulty with sexual 

intercourse, lower abdominal 

discomfort, and voiding and difficulties 

with defecation. Typically, the patient 

feels a bulge in the lower vagina or the 

cervix protruding through the vaginal 

opening. Cystoceles, rectoceles, or 

enteroceles may cause symptoms 

commonly associated with pelvic organ 

prolapse and lead to patient complaints 

of difficulty with voiding or bowel 

movements, recurrent urinary 

infections, and/or ‘‘splinting’’ (manually 

supporting the perineum) to defecate. 

Cespedes RD, Cross CA, McGuire EJ., 

‘‘Pelvic Prolapse: Diagnosing and 

Treating Uterine and Vaginal Vault 

Prolapse,’’ 1(3) MedGenMed (1999). 

Menstrual abnormalities may occur in 

women with or without pelvic organ 


tkelley on DSK3SPTVN1PROD with PROPOSALS
10640 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules 

prolapse, but there is usually no causal 

relationship or association. Therefore, 

the references to menstrual 

disturbances, irregular menstruation 

and adhesions as symptoms of uterine 

prolapse (displacement) should be 

removed, because they do not reflect 

current medical science and practice. 

Finally, and as a consequence of this 

proposed consolidation, VA also 

proposes to delete current diagnostic 

codes 7622 ‘‘Uterus, displacement of’’ 

and 7623 ‘‘Pregnancy, surgical 

complications of’’ as the evaluation 

criteria are now contained in the 

proposed diagnostic code 7621. 

Diagnostic Codes 7627 ‘‘Malignant 

neoplasms of gynecological system or 

breast’’ and 7628 ‘‘Benign neoplasms of 

the gynecological system or breast’’ 

Current diagnostic codes 7627 and 

7628 address impairment associated 

with malignant and benign neoplasms 

of the gynecological system and the 

breast. VA proposes to restructure the 

current rating criteria by separating the 

evaluations for impairments due to 

gynecological neoplasms from the 

evaluations for impairments due to 

breast neoplasms. This proposed 

separation keeps disability 

compensation data related to male 

breast cancer and non-cancerous tumors 

separate from disability compensation 

data related to gynecological neoplasms 

and also provides ease of use for 

disability rating specialists. Men possess 

a small amount of nonfunctioning breast 

tissue (breast tissue that cannot produce 

milk) that is concentrated in the area 

directly behind the nipple on the chest 

wall. Like breast cancer in women, 

cancer of the male breast is the 

uncontrolled growth of the abnormal 

cells of this breast tissue. Male breast 

cancer constitutes about 1 percent of all 

cases of breast cancers. ‘‘Male Breast 

Cancer,’’ National Cancer Institute— 

National Institutes of Health (Updated 

Sept. 19, 2013), http://www.cancer.gov/ 

cancertopics/pdq/treatment/malebreast/

Patient/page1 (last accessed Jan. 21, 

2014). 

Therefore, VA proposes to retitle 

diagnostic code 7627 as, ‘‘Malignant 

neoplasms of gynecological system’’ and 

diagnostic code 7628 as, ‘‘Benign 

neoplasms of gynecological system.’’ 

Additionally, under diagnostic codes 

7627 and 7628, VA proposes to clarify 

the existing note which instructs rating 

specialists to rate chronic residuals 

(following surgery or other treatments). 

Specifically, VA proposes to identify 

those chronic residuals commonly 

associated with treatment for neoplasms 

of the gynecological system, to include 

impairment of function due to scars, 

lymphedema, or disfigurement, as well 

as to direct rating specialists to evaluate 

any other residual impairment of 

function, including gynecological, 

under appropriate diagnostic code(s) 

within the appropriate body system. 

The surgical management of gynecologic 

malignancies and benign diseases has 

evolved over the last decades. However, 

these sometimes complex procedures 

encompass radical pelvic and upper 

abdominal surgery, including associated 

urologic and intestinal procedures that 

may be required to remove the 

neoplasm. Oliver Zivanovic & Dennis 

Chi, ‘‘Surgical Resection and 

Reconstruction for Advanced and 

Recurrent Gynecologic Malignancies,’’ 3 

Expert Rev. of Obstetrics & Gynecology 

677, 677–690 (2008). Additionally, VA 

proposes a minor editorial revision of 

replacing the word ‘‘X-ray’’ with the 

word ‘‘radiation’’ as it pertains to 

therapeutic procedure to reflect a 

change in medical terminology. 

Within this reorganization, VA also 

proposes to add two new diagnostic 

codes, 7630 ‘‘Malignant neoplasms of 

the breast’’ and 7631 ‘‘Benign 

neoplasms of the breast and other 

injuries of the breast’’ in order to 

account for impairment due to benign 

and malignant breast tumors 

(neoplasms) as well as other injuries to 

the breast not included elsewhere in the 

VASRD. This addition would allow VA 

to adequately evaluate and track 

disabilities due to benign breast 

neoplasms as well as other injuries, 

such as blast trauma. VA proposes to 

place two notes under diagnostic codes 

7630 and 7631 to identify common 

chronic residuals associated with 

injuries of the breast and benign and 

malignant breast tumors and to instruct 

rating specialists to rate accordingly. 

Breast surgery is the most common 

choice of treatment for benign and 

malignant tumors of the breast and is an 

established risk factor for development 

of scars, lymphedema, or disfigurement. 

These chronic post-treatment residuals 

result in functional impairment such as 

limitation of arm, shoulder, and wrist 

motion, or loss of grip strength, or loss 

of sensation, or residuals from 

harvesting of muscles for reconstructive 

purposes. Angelique F. Vitug & Lisa A. 

Newman, ‘‘Complications in Breast 

Surgery,’’ 87 Surgical Clinics of North 

America 431, 431–451 (2007). 

The proposed notes will therefore 

instruct rating specialists to rate chronic 

residuals according to impairment of 

function due to scars, lymphedema, or 

disfigurement (e.g., limitation of arm, 

shoulder, and wrist motion, or loss of 

grip strength, or loss of sensation, or 

residuals from harvesting of muscles for 

reconstructive purposes), and/or under 

diagnostic code 7626, if appropriate. 

Again, no change to the existing 

evaluation criteria (found in current 

diagnostic codes 7627 and 7628) is 

proposed. 

New Diagnostic Code 7632 ‘‘Female 

sexual arousal disorder (FSAD)’’ 

VA proposes to add a new diagnostic 

code 7632, titled ‘‘Female sexual arousal 

disorder (FSAD),’’ in order to account 

for impairment due to this condition in 

the female Veteran population. FSAD 

refers to the continual or recurrent 

inability of a woman to accomplish or 

maintain an ample lubrication-swelling 

reaction during sexual intercourse. This 

lack of physical response may be either 

lifelong or acquired, and either 

generalized or situation-specific. FSAD 

is the second most common sexual 

health concern for women, affecting 26 

percent of adult women. Emma Hitt, 

‘‘Alprostadil Shows Efficacy in Female 

Sexual Arousal Disorder’’ (May 25, 

2012), Medscape, http://

www.medscape.com/viewarticle/764590 

(last accessed Jan. 21, 2014). Current 

statistics show that FSAD affects an 

estimated 30 to 45 million women in the 

United States alone. Medscape Medical 

News, ‘‘Potential Drug Therapy for 

Female Sexual Dysfunction Presented’’ 

(June 28, 2000), Medscape, http://

www.medscape.com/viewarticle/411930 

(last accessed Jan. 21, 2014). Clinical 

research shows that some aspects of 

FSAD are likely caused in part by 

decreased blood flow to the genital area. 

Therefore, poor genital blood flow is 

believed to contribute to FSAD similar 

to the role of vascular disease in male 

erectile dysfunction. Medscape Medical 

News, ‘‘New Approaches to Female 

Sexual Arousal Disorder’’ (May 31, 

2001), Medscape, http://

www.medscape.com/viewarticle/434478 

(last accessed Jan. 21, 2014). Although 

treatment of sexual dysfunction in men 

has been improved by currently 

marketed pharmaceuticals there are no 

US Food and Drug Administration 

(FDA) approved treatments for FSAD. 

FDA recently issued draft guidance for 

industry regarding clinical development 

of drug products for FSAD. 

Currently, male Veterans with service 

connected penile deformity and loss of 

erectile power receive a 20 percent 

disability evaluation under diagnostic 

code 7522 and are eligible for special 

monthly compensation. In cases where 

there is no penile deformity present, but 

there is service connected loss of 

erectile power, VA’s policy is to 

evaluate male Veterans analogous to 

diagnostic code 7522, assigning a 0 

percent rating; Eligibility for special 


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Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules 10641 

monthly compensation due to loss of 

use of a creative organ (SMC–K) is also 

considered. See 38 CFR 4.20 and 4.115b, 

Diagnostic Code 7522. 

In order to ensure gender parity, VA 

proposes the creation of a new 

diagnostic code 7632 ‘‘Female sexual 

arousal disorder (FSAD).’’ There is no 

diagnostic code in current § 4.116 which 

allows for analogous rating of female 

sexual arousal disorder, to include 

consideration of special monthly 

compensation. Under proposed 

diagnostic code 7632, female Veterans 

with service connected FSAD but 

without physical damage to female 

genitalia would be evaluated at 0 

percent with a note directing rating 

personnel to consider eligibility for 

special monthly compensation (SMC– 

K). 

Technical Amendments 

VA also proposes several technical 

amendments. We would add a citation 

reference to 38 U.S.C. 1155 at the end 

of § 4.116, and we would update 

Appendix A, B, and C of part 4 to reflect 

the above noted proposed amendments. 

Executive Orders 12866 and 13563 

Executive Orders 12866 and 13563 

direct agencies to assess the 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 

effects, and other advantages; 

distributive impacts; and equity). 

Executive Order 13563 (Improving 

Regulation and Regulatory Review) 

emphasizes the importance of 

quantifying both costs and benefits, 

reducing costs, harmonizing rules, and 

promoting flexibility. Executive Order 

12866 (Regulatory Planning and 

Review) defines a ‘‘significant 

regulatory action,’’ requiring review by 

the Office of Management and Budget 

(OMB), unless OMB waives such 

review, as ‘‘any regulatory action that is 

likely to result in a rule that may: (1) 

Have an annual effect on the economy 

of $100 million or more or adversely 

affect in a material way the economy, a 

sector of the economy, productivity, 

competition, jobs, the environment, 

public health or safety, or State, local, 

or tribal governments or communities; 

(2) Create a serious inconsistency or 

otherwise interfere with an action taken 

or planned by another agency; (3) 

Materially alter the budgetary impact of 

entitlements, grants, user fees, or loan 

programs or the rights and obligations of 

recipients thereof; or (4) Raise novel 

legal or policy issues arising out of legal 

mandates, the President’s priorities, or 

the principles set forth in this Executive 

Order.’’ 

The economic, interagency, 

budgetary, legal, and policy 

implications of this proposed rule have 

been examined, and it has been 

determined not to be a significant 

regulatory action under Executive Order 

12866. VA’s impact analysis can be 

found as a supporting document at 

http://www.regulations.gov, usually 

within 48 hours after the rulemaking 

document is published. Additionally, a 

copy of this rulemaking and its impact 

analysis are available on VA’s Web site 

at http://www.va.gov/orpm/, by 

following the link for ‘‘VA Regulations 

Published From FY 2004 Through Fiscal 

Year to Date.’’ 

Regulatory Flexibility Act 

The Secretary hereby certifies that 

this proposed rule would not have a 

significant economic impact on a 

substantial number of small entities as 

they are defined in the Regulatory 

Flexibility Act, 5 U.S.C. 601–612. This 

proposed rule would not affect any 

small entities. Only certain VA 

beneficiaries could be directly affected. 

Therefore, pursuant to 5 U.S.C. 605(b), 

this rulemaking is exempt from the 

initial and final regulatory flexibility 

analysis requirements of sections 603 

and 604. 

Unfunded Mandates 

The Unfunded Mandates Reform Act 

of 1995 requires, at 2 U.S.C. 1532, that 

agencies prepare an assessment of 

anticipated costs and benefits before 

issuing any rule that may result in the 

expenditure by State, local, and tribal 

governments, in the aggregate, or by the 

private sector, of $100 million or more 

(adjusted annually for inflation) in any 

one year. This proposed rule would 

have no such effect on State, local, and 

tribal governments, or on the private 

sector. 

Paperwork Reduction Act 

This proposed rule contains no 

provisions constituting a collection of 

information under the Paperwork 

Reduction Act of 1995 (44 U.S.C. 3501– 

3521). 

Catalog of Federal Domestic Assistance 

The Catalog of Federal Domestic 

Assistance program numbers and titles 

for this rule are 64.009, Veterans 

Medical Care Benefits; 64.104, Pension 

for Non-Service-Connected Disability 

for Veterans; 64.109, Veterans 

Compensation for Service-Connected 

Disability; and 64.110, Veterans 

Dependency and Indemnity 

Compensation for Service Connected 

Death. 

Signing Authority 

The Secretary of Veterans Affairs, or 

designee, approved this document and 

authorized the undersigned to sign and 

submit the document to the Office of the 

Federal Register for publication 

electronically as an official document of 

the Department of Veterans Affairs. Jose 

D. Riojas, Chief of Staff, Department of 

Veterans Affairs, approved this 

document on December 1, 2014, for 

publication. 

List of Subjects in 38 CFR Part 4 

Disability benefits, Pensions, 

Veterans. 

Dated: February 20, 2015. 

William F. Russo, 

Acting Director, Office of Regulation Policy 

& Management, Office of the General Counsel, 

U.S. Department of Veterans Affairs. 

For the reasons set out in the 

preamble, VA proposes to amend 38 

CFR part 4 as follows: 

PART 4—SCHEDULE FOR RATING 

DISABILITIES 

■ 1. The authority citation for part 4 

continues to read as follows: 

Authority: 38 U.S.C. 1155, unless 

otherwise noted. 

Subpart B—Disability Ratings 

■ 2. Amend § 4.116 as follows: 

■ a. Revise the entry for diagnostic code 

7610; 

■ b. Add a note at the end of the entries 

for diagnostic codes 7615 and 7619; 

■ c. Revise the entry for diagnostic code 

7621; 

■ d. Remove the entries for diagnostic 

codes 7622 and 7623; 

■ e. Revise the entries for diagnostic 

codes 7627 and 7628; 

■ f. Add entries for diagnostic codes 

7630 through 7632 in numerical order; 

and 

■ g. Add an authority citation at the end 

of the section. 

The revisions and additions to read as 

follows: 

§ 4.116 Schedule of ratings— 

gynecological conditions and disorders of 

the breast. 


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10642 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules 

Rating 

*******

7610 Vulva or clitoris, disease or injury of (including vulvovaginitis). 

*******

7615 * * * 

Note: For the purpose of VA disability evaluation, a disease, injury, or adhesions of the ovaries resulting in ovarian dysfunction affecting the menstrual cycle, such as dysmenorrhea and secondary amenorrhea, shall be rated under diagnostic code 7615. 

*******

7619 * * * 

Note: In cases of the removal of one ovary as the result of a service-connected injury or disease, with the absence or nonfunctioning of a second ovary unrelated to service, an evaluation of 30 percent will be assigned for the service-connected 

ovarian loss. 

*******

7621 Pelvic organ prolapse due to injury, disease, or surgical complications of pregnancy. 

Severe prolapse: Complete or almost complete eversion of the total length of the vagina shown on examination, with the 

length of the protrusion (or prolapse) extending beyond the hymen within 2 cm of total vaginal length ................................ 50 

Moderate prolapse: On examination the most severe portion of the prolapse is more than 1 cm below the hymen, but protrudes no further than 2 cm less than the total vaginal length ................................................................................................. 30 

Mild prolapse: On examination the most severe portion of the prolapse is between 1 cm or less above the hymen and 1 cm 

or more below the hymen ......................................................................................................................................................... 10 

Note: Pelvic organ prolapse occurs when a pelvic organ such as bladder, urethra, uterus, vagina, small bowel, or rectum 

drops (prolapse) from its normal place in the abdomen. Conditions associated with pelvic organ prolapse include: Uterine 

or vaginal vault prolapse, cystocele, urethrocele, rectocele, enterocele, or any combination thereof. 

*******

7627 Malignant neoplasms of gynecological system ....................................................................................................................... 100 

Note: A rating of 100 percent shall continue beyond the cessation of any surgical, radiation, antineoplastic chemotherapy 

or other therapeutic procedures. Six months after discontinuance of such treatment, the appropriate disability rating shall 

be determined by mandatory VA examination. Any change in evaluation based upon that or any subsequent examination 

shall be subject to the provisions of § 3.105(e) of this chapter. Rate chronic residuals to include scars, lymphedema, disfigurement, and/or other impairment of function under the appropriate diagnostic code(s) within the appropriate body system. 

7628 Benign neoplasms of gynecological system. Rate chronic residuals to include scars, lymphedema, disfigurement, and/or 

other impairment of function under the appropriate diagnostic code(s) within the appropriate body system. 

* * * * * * * 

7630 Malignant neoplasms of the breast ............................................................................................................................................ 100 

Note: A rating of 100 percent shall continue beyond the cessation of any surgical, radiation, antineoplastic chemotherapy 

or other therapeutic procedure. Six months after discontinuance of such treatment, the appropriate disability rating shall 

be determined by mandatory VA examination. Any change in evaluation based upon that or any subsequent examination 

shall be subject to the provisions of § 3.105(e) of this chapter. Rate chronic residuals according to impairment of function 

due to scars, lymphedema, or disfigurement (e.g., limitation of arm, shoulder, and wrist motion, or loss of grip strength, or 

loss of sensation, or residuals from harvesting of muscles for reconstructive purposes), and/or under diagnostic code 

7626. 

7631 Benign neoplasms of the breast and other injuries of the breast. Rate chronic residuals according to impairment of function due to scars, lymphedema, or disfigurement (e.g., limitation of arm, shoulder, and wrist motion, or loss of grip strength, or 

loss of sensation, or residuals from harvesting of muscles for reconstructive purposes), and/or under diagnostic code 7626. 

7632 Female sexual arousal disorder (FSAD) .................................................................................................................................. 1 0 

1 Review for entitlement to special monthly compensation under § 3.350 of this chapter. 

(Authority: 38 U.S.C. 1155) 

■ 3. Amend Appendix A to Part 4 as 

follows: 

■ a. At Sec. 4.116, revise the entries for 

diagnostic codes 7610, 7615, 7619, 

7621, 7622, 7623, 7627, and 7628; and 

■ b. At Sec. 4.116, add entries for 

diagnostic codes 7630 through 7632 in 

numerical order. 

The revisions and additions to read as 

follows: 

Appendix A to Part 4—Table of 

Amendments and Effective Dates Since 

1946 

Sec. Diagnostic 

code No. 

*******

4.116. 

*******

7610 Criterion May 22, 1995; title [effective date of final rule]. 


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Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules 10643 

Sec. Diagnostic 

code No. 

*******

7615 Criterion May 22, 1995; note [effective date of final rule]. 

*******

7619 Criterion May 22, 1995; note [effective date of final rule]. 

*******

7621 Criterion May 22, 1995; evaluation [effective date of final rule]. 

7622 Removed [effective date of final rule]. 

7623 Removed [effective date of final rule]. 

*******

7627 Criterion March 10, 1976; criterion May 22, 1995; title, note [effective date of final rule]. 

7628 Added May 22, 1995; title, criterion [effective date of final rule]. 

*******

7630 Added [effective date of final rule]. 

7631 Added [effective date of final rule]. 

7632 Added [effective date of final rule]. 

* * * * * * * 

■ 4. Amend Appendix B to Part 4 as 

follows: 

■ a. Revise the entries for diagnostic 

codes 7610, 7621, 7627, and 7628; and 

■ b. Add entries for diagnostic codes 

7630 through 7632 in numerical order. 

The revisions and additions to read as 

follows: 

Appendix B to Part 4—Numerical Index 

of Disabilities 

Diagnostic 

code No. 

*******

Gynecological Conditions and Disorders of the Breast 

7610 .............. Vulva or clitoris, disease or injury of (including vulvovaginitis). 

* * * * * * * 

7621 .............. Pelvic organ prolapse due to injury or disease or surgical complications of pregnancy. 

* * * * * * * 

7627 .............. Malignant neoplasms of gynecological system. 

7628 .............. Benign neoplasms of gynecological system. 

* * * * * * * 

7630 .............. Malignant neoplasms of the breast. 

7631 .............. Benign neoplasms of the breast and other injuries of the breast. 

7632 .............. Female sexual arousal disorder (FSAD). 

* * * * * * * 

■ 5. Amend Appendix C to Part 4 as 

follows: 

■ a. Add in alphabetical order the 

heading ‘‘Female sexual arousal 

disorder (FSAD)’’ and its diagnostic 

code ‘‘7632’’. 

■ b. Under the heading ‘‘Injury’’ add in 

alphabetical order new entry ‘‘Breast’’ 

and its diagnostic code ‘‘7631’’. 

■ c. Under the heading ‘‘Neoplasms: 

Benign:’’ add in alphabetical order an 

entry ‘‘Breast’’ and its diagnostic code 

‘‘7631’’. 

■ d. Under the heading ‘‘Neoplasms: 

Benign:’’ remove ‘‘Gynecological or 

breast’’ and in its place add the entry 

‘‘Gynecological’’. 

■ e. Under the heading ‘‘Neoplasms: 

Malignant:’’ add in alphabetical order 

new entry ‘‘Breast’’ and its diagnostic 

code ‘‘7630’’. 

■ f. Under the heading ‘‘Neoplasms: 

Malignant:’’ remove ‘‘Gynecological or 

breast’’ and in its place add the entry 

‘‘Gynecological’’. 

■ g. Add in alphabetical order the 

heading ‘‘Pelvic organ prolapse due to 

injury or disease or surgical 

complications of pregnancy, including 

uterine or vaginal vault prolapse, 

cystocele, urethrocele, rectocele, 

enterocele, or combination’’ and its 

diagnostic code ‘‘7621’’. 

■ h. Remove the heading ‘‘Pregnancy, 

surgical complications’’ and its 

diagnostic code ‘‘7623’’. 


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10644 Federal Register / Vol. 80, No. 39 / Friday, February 27, 2015 / Proposed Rules 

■ i. Under the heading ‘‘Uterus’’ remove 

the entry ‘‘Displacement’’ and its 

diagnostic code ‘‘7622’’. 

■ j. Remove the heading ‘‘Vulva disease 

or injury of’’ and add in its place ‘‘Vulva 

or clitoris, disease or injury of’’. 

The additions and revisions to read as 

follows: 

Appendix C to Part 4—Alphabetical 

Index of Disabilities 

Diagnostic 

code No. 

*******

Female sexual arousal disorder (FSAD) ............................................................................................................................................. 7632 

* * * * * * * 

Injury: 

* * * * * * * 

Breast ........................................................................................................................................................................................... 7631 

*******

Neoplasms: 

Benign: 

Breast .................................................................................................................................................................................... 7631 

* * * * * * * 

Gynecological ........................................................................................................................................................................ 7628 

*******

Malignant: 

Breast .................................................................................................................................................................................... 7630 

*******

Gynecological ........................................................................................................................................................................ 7627 

*******

Pelvic organ prolapse due to injury or disease or surgical complications of pregnancy, including uterine or vaginal vault 

prolapse, cystocele, urethrocele, rectocele, enterocele, or combination ......................................................................................... 7621 

*******

Vulva or clitoris, disease or injury of ................................................................................................................................................... 7610 

*******

[FR Doc. 2015–03851 Filed 2–26–15; 8:45 am] 

BILLING CODE 8320–01–P 

ENVIRONMENTAL PROTECTION 

AGENCY 

40 CFR Part 52 

[EPA–R05–OAR–2012–0991; EPA–R05– 

OAR–2013–0435; FRL–9923–43–Region 5] 

Approval and Promulgation of Air 

Quality Implementation Plans; Indiana; 

Infrastructure SIP Requirements for 

the 2010 NO2 and SO2 NAAQS 

AGENCY: Environmental Protection 

Agency. 

ACTION: Proposed rule. 

SUMMARY: The Environmental Protection 

Agency (EPA) is proposing to approve 

elements of state implementation plan 

(SIP) submissions from Indiana 

regarding the infrastructure 

requirements of section 110 of the Clean 

Air Act (CAA) for the 2010 nitrogen 

dioxide (NO2) and sulfur dioxide (SO2) 

National Ambient Air Quality Standards 

(NAAQS). The infrastructure 

requirements are designed to ensure that 

the structural components of each 

state’s air quality management program 

are adequate to meet the state’s 

responsibilities under the CAA. 

DATES: Comments must be received on 

or before March 30, 2015. 

ADDRESSES: Submit your comments, 

identified by Docket ID No. EPA–R05– 

OAR–2012–0991 (2010 NO2

infrastructure SIP elements) and Docket 

ID No. EPA–R05–OAR–2013–0435 

(2010 SO2 infrastructure SIP elements) 

by one of the following methods: 

1. www.regulations.gov: Follow the 

on-line instructions for submitting 

comments. 

2. Email: aburano.douglas@epa.gov. 

3. Fax: (312) 408–2279. 

4. Mail: Douglas Aburano, Chief, 

Attainment Planning and Maintenance 

Section, Air Programs Branch (AR–18J), 

U.S. Environmental Protection Agency, 

77 West Jackson Boulevard, Chicago, 

Illinois 60604. 

5. Hand Delivery: Douglas Aburano, 

Chief, Attainment Planning and 

Maintenance Section, Air Programs 

Branch (AR–18J), U.S. Environmental 

Protection Agency, 77 West Jackson 

Boulevard, Chicago, Illinois 60604. 

Such deliveries are only accepted 

during the Regional Office normal hours 

of operation, and special arrangements 

should be made for deliveries of boxed 

information. The Regional Office official 

hours of business are Monday through 

Friday, 8:30 a.m. to 4:30 p.m., excluding 

Federal holidays. 

Instructions: Direct your comments to 

Docket ID. EPA–R05–OAR–2012–0991 

and EPA–R05–OAR–2013–0435. EPA’s 

policy is that all comments received 

will be included in the public docket 

without change and may be made 

available online at www.regulations.gov, 

including any personal information 

provided, unless the comment includes 

information claimed to be Confidential 

Business Information (CBI) or other 

information whose disclosure is 

restricted by statute. Do not submit 

information that you consider to be CBI 

or otherwise protected through 

www.regulations.gov or email. The 


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