76718 Federal Register / Vol. 79, No. 245 / Monday, December 22, 2014 / Unified Agenda 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Office of the Secretary 

21 CFR Ch. I 

25 CFR Ch. V 

42 CFR Chs. I–V 

45 CFR Subtitle A; Subtitle B, Chs. II, 

III, and XIII 

Regulatory Agenda 

AGENCY: Office of the Secretary, HHS. 

ACTION: Semiannual regulatory agenda. 

SUMMARY: The Regulatory Flexibility Act 

of 1980 and Executive Order (EO) 12866 

require the semiannual issuance of an 

inventory of rulemaking actions under 

development throughout the 

Department, offering for public review 

summarized information about 

forthcoming regulatory actions. 

FOR FURTHER INFORMATION CONTACT: 

C’Reda J. Weeden, Executive Secretary, 

Department of Health and Human 

Services, 200 Independence Avenue 

SW., Washington, DC 20201; (202) 690– 

5627. 

SUPPLEMENTARY INFORMATION: The 

Department of Health and Human 

Services (HHS) is the Federal 

Government’s lead agency for protecting 

the health of all Americans and 

providing essential human services, 

especially for those who are least able 

to help themselves. HHS enhances the 

health and well-being of Americans by 

promoting effective health and human 

services and by fostering sound, 

sustained advances in the sciences 

underlying medicine, public health, and 

social services. 

This Agenda presents the rulemaking 

activities that the Department expects to 

undertake in the foreseeable future to 

advance this mission. The Agenda 

furthers several Departmental goals, 

including strengthening health care; 

advancing scientific knowledge and 

innovation; advancing the health, safety, 

and well-being of the American people; 

increasing efficiency, transparency, and 

accountability of HHS programs; and 

strengthening the Nation’s health and 

human services infrastructure and 

workforce. 

HHS has an agency-wide effort to 

support the Agenda’s purpose of 

encouraging more effective public 

participation in the regulatory process. 

For example, to encourage public 

participation, we regularly update our 

regulatory Web page (http:// 

www.HHS.gov/regulations) which 

includes links to HHS rules currently 

open for public comment, and also 

provides a ‘‘regulations toolkit’’ with 

background information on regulations, 

the commenting process, how public 

comments influence the development of 

a rule, and how the public can provide 

effective comments. HHS also actively 

encourages meaningful public 

participation in its retrospective review 

of regulations, through a comment form 

on the HHS retrospective review Web 

page (http://www.HHS.gov/ 

RetrospectiveReview). 

The rulemaking abstracts included in 

this paper issue of the Federal Register 

cover, as required by the Regulatory 

Flexibility Act of 1980, those 

prospective HHS rulemakings likely to 

have a significant economic impact on 

a substantial number of small entities. 

The Department’s complete Regulatory 

Agenda is accessible online at http:// 

www.RegInfo.gov. 

Dated: September 22, 2014. 

C’Reda J. Weeden, 

Executive Secretary to the Department. 

SUBSTANCE ABUSE AND MENTAL HEALTH SERVICES ADMINISTRATION—PROPOSED RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

275 .................... SAMHSA User Fees for Publications .............................................................................................................. 0930–AA18 

FOOD AND DRUG ADMINISTRATION—PROPOSED RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

276 .................... Over-the-Counter (OTC) Drug Review—Cough/Cold (Antihistamine) Products ............................................. 0910–AF31 

277 .................... Over-the-Counter (OTC) Drug Review—Internal Analgesic Products ............................................................ 0910–AF36 

278 .................... Over-the-Counter (OTC) Drug Review—Topical Antimicrobial Drug Products ............................................... 0910–AF69 

279 .................... Abbreviated New Drug Applications and 505(b)(2) ......................................................................................... 0910–AF97 

280 .................... Updated Standards for Labeling of Pet Food .................................................................................................. 0910–AG09 

281 .................... Current Good Manufacturing Practice and Hazard Analysis and Risk-Based Preventive Controls for Food 

for Animals (Reg Plan Seq No. 48).

0910–AG10 

282 .................... Over-the-Counter (OTC) Drug Review—Pediatric Dosing for Cough/Cold Products ..................................... 0910–AG12 

283 .................... Electronic Distribution of Prescribing Information for Human Prescription Drugs Including Biological Products.0910–AG18 

284 .................... Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Reg 

Plan Seq No. 49).

0910–AG35 

285 .................... Current Good Manufacturing and Hazard Analysis, and Risk-Based Preventive Controls for Human Food 

(Reg Plan Seq No. 50).

0910–AG36 

286 .................... Requirements for the Testing and Reporting of Tobacco Product Constituents, Ingredients, and Additives 0910–AG59 

287 .................... Foreign Supplier Verification Program (Reg Plan Seq No. 52) ...................................................................... 0910–AG64 

288 .................... Format and Content of Reports Intended to Demonstrate Substantial Equivalence ...................................... 0910–AG96 

289 .................... Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods ..................................... 0910–AH00 

290 .................... Radiology Devices; Designation of Special Controls for the Computed Tomography X-Ray System ........... 0910–AH03 

291 .................... Mammography Quality Standards Act; Regulatory Amendments ................................................................... 0910–AH04 

292 .................... Investigational New Drug Application Annual Reporting ................................................................................. 0910–AH07 

293 .................... General and Plastic Surgery Devices: Sunlamp Products .............................................................................. 0910–AH14 

References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. 


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FOOD AND DRUG ADMINISTRATION—FINAL RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

294 .................... Requirements for Foreign and Domestic Establishment Registration and Listing for Human Drugs, Including Drugs That Are Regulated Under a Biologics License Application, and Animal Drugs.0910–AA49 

295 .................... Content and Format of Labeling for Human Prescription Drugs and Biologics; Requirements for Pregnancy and Lactation Labeling.0910–AF11 

296 .................... Combinations of Bronchodilators With Nasal Decongestant; Cold, Cough, Allergy, Bronchodilator, and 

Antiasthmatic Drug Products for Over-the-Counter Human Use.

0910–AF33 

297 .................... Over-the-Counter (OTC) Drug Review—Laxative Drug Products ................................................................... 0910–AF38 

298 .................... Laser Products; Amendment to Performance Standard .................................................................................. 0910–AF87 

299 .................... ‘‘Tobacco Products’’ Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family 

Smoking Prevention and Tobacco Control Act (Reg Plan Seq No. 53).

0910–AG38 

300 .................... Human Subject Protection; Acceptance of Data From Clinical Investigations for Medical Devices ............... 0910–AG48 

301 .................... Food Labeling: Calorie Labeling of Articles of Food Sold in Vending Machines (Reg Plan Seq No. 54) ..... 0910–AG56 

302 .................... Food Labeling: Nutrition Labeling of Standard Menu Items in Restaurants and Similar Retail Food Establishments (Reg Plan Seq No. 55).0910–AG57 

303 .................... Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products 

(Reg Plan Seq No. 58).

0910–AG94 

304 .................... Veterinary Feed Directive (Reg Plan Seq No. 59) ......................................................................................... 0910–AG95 

305 .................... Combinations of Bronchodilators With Expectorants; Cold, Cough, Allergy, Bronchodilator, and Antiasthmatic Drug Products for Over-the-Counter Human Use.0910–AH16 

References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. 

FOOD AND DRUG ADMINISTRATION—LONG-TERM ACTIONS

Sequence No. Title Regulation 

Identifier No. 

306 .................... Food Labeling; Revision of the Nutrition and Supplement Facts Labels ........................................................ 0910–AF22 

307 .................... Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One-Eating Occasion; 

Dual-Column Labeling; Updating, Modifying, and Establishing Certain RACCs.

0910–AF23 

308 .................... Focused Mitigation Strategies To Protect Food Against Intentional Adulteration ........................................... 0910–AG63 

309 .................... Sanitary Transportation of Human and Animal Food ...................................................................................... 0910–AG98 

FOOD AND DRUG ADMINISTRATION—COMPLETED ACTIONS

Sequence No. Title Regulation 

Identifier No. 

310 .................... Infant Formula: Current Good Manufacturing Practices; Quality Control Procedures; Notification Requirements; Records and Reports; and Quality Factors.0910–AF27 

311 .................... Postmarketing Safety Reports for Human Drug and Biological Products: Electronic Submission Requirements.0910–AF96 

312 .................... Requirements for the Submission of Data Needed to Calculate User Fees for Domestic Manufacturers 

and Importers of Tobacco Products.

0910–AG81 

CENTERS FOR MEDICARE & MEDICAID SERVICES—PROPOSED RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

313 .................... Home Health Agency Conditions of Participation (CMS–3819–F) (Rulemaking Resulting From a Section 610 Review).0938–AG81 

314 .................... Reform of Requirements for Long-Term Care Facilities (CMS–3260–P) (Rulemaking Resulting From a 

Section 610 Review) (Reg Plan Seq No. 60).

0938–AR61 

315 .................... Medicare Shared Savings Program; Accountable Care Organizations (CMS–1461–P) (Section 610 Review).0938–AS06 

316 .................... Hospital and Critical Access Hospital (CAH) Changes to Promote Innovation, Flexibility, and Improvement 

in Patient Care (CMS–3295–P) (Rulemaking Resulting From a Section 610 Review).

0938–AS21 

317 .................... Medicare Clinical Diagnostic Laboratory Test Payment System (CMS–1621–P) ........................................... 0938–AS33 

318 .................... CY 2016 Revisions to Payment Policies under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1631–P) (Reg Plan Seq No. 63).0938–AS40 

319 .................... Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2016 Rates (CMS–1632–P) (Reg Plan Seq No. 64).0938–AS41 

320 .................... CY 2016 Hospital Outpatient PPS Policy Changes and Payment Rates and Ambulatory Surgical Center 

Payment System Policy Changes and Payment Rates (CMS–1633–P) (Reg Plan Seq No. 65).

0938–AS42 

References in boldface appear in The Regulatory Plan in part II of this issue of the Federal Register. 


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CENTERS FOR MEDICARE & MEDICAID SERVICES—FINAL RULE STAGE

Sequence No. Title Regulation 

Identifier No. 

321 .................... Covered Outpatient Drugs (CMS–2345–F) (Section 610 Review) ................................................................ 0938–AQ41 

CENTERS FOR MEDICARE & MEDICAID SERVICES—LONG-TERM ACTIONS

Sequence No. Title Regulation 

Identifier No. 

322 .................... Emergency Preparedness Requirements for Medicare and Medicaid Participating Providers and Suppliers 

(CMS–3178–F).

0938–AO91 

323 .................... Adoption of Operating Rules for HIPAA Transactions (CMS–0036–IFC) ....................................................... 0938–AS01 

CENTERS FOR MEDICARE & MEDICAID SERVICES—COMPLETED ACTIONS

Sequence No. Title Regulation 

Identifier No. 

324 .................... Prospective Payment System for Federally Qualified Health Centers; Changes to Contracting Policies for 

Rural Health Clinics and CLIA Enforcement Actions for Proficiency Testing Referral (CMS–1443–FC) 

(Completion of a Section 610 Review).

0938–AR62 

325 .................... Hospital Inpatient Prospective Payment System for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2015 Rates (CMS–1607–F) (Completion of a Section 610 Review).0938–AS11 

326 .................... CY 2015 Revisions to Payment Policies Under the Physician Fee Schedule and Other Revisions to Medicare Part B (CMS–1612–FC) (Section 610 Review).0938–AS12 

327 .................... CY 2015 End-Stage Renal Disease Prospective Payment System, Quality Incentive Program, and Durable Medical Equipment, Prosthetics, Orthotics, and Supplies (CMS–1614–F) (Section 610 Review).0938–AS13 

328 .................... CY 2015 Hospital Outpatient Prospective Payment System (PPS) Policy Changes and Payment Rates, 

and CY 2015 Ambulatory Surgical Center Payment System Policy Changes and Payment Rates (CMS– 

1613–FC) (Section 610 Review).

0938–AS15 

329 .................... Extension of Payment Adjustment for Low-Volume Hospitals and the Medicare-Dependent Hospital Program Under the FY 2014 Hospital Inpatient Prospective Payment System (CMS–1599–IFC2) (Completion of a Section 610 Review).0938–AS18 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Substance Abuse and Mental Health 

Services Administration (SAMHSA) 

Proposed Rule Stage 

275. SAMHSA User Fees for 

Publications 

Legal Authority: 31 U.S.C. 9701; 31 

U.S.C. 1111; EO 8284; EO 11541; Pub. 

L. 113–76 

Abstract: SAMSHA is proposing to 

implement a modest cost recovery 

program to partially offset the high costs 

of distributing its materials to the 

public. This user fee would apply only 

to ‘‘over-the-limit’’ non-governmental 

orders. An ‘‘over the limit’’ order is 

defined as an order that exceeds either 

the average weight value (3.75 lbs) or 

the average number of copies (8). The 

‘‘non-governmental orders’’ do not 

include: SAMHSA’s Recovery Month 

bulk orders; orders by SAMHSA staff for 

meetings or conferences; and orders 

from ‘‘.gov’’ and ‘‘.mil’’ addresses. 

Therefore, it is assumed that SAMHSA 

would not charge shipping for orders by 

other Federal, State, and local 

government agencies. The proposed rule 

would implement recent legislation 

allowing the funds collected as part of 

a user fee for publications and data 

requests to be available to SAMHSA 

until expended. 

Timetable: 

Action Date FR Cite 

NPRM .................. 02/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Brian Altman, 

Legislative Director, Department of 

Health and Human Services, Substance 

Abuse and Mental Health Services 

Administration, 1 Choke Cherry Road, 

Rockville, MD 02857, Phone: 240 276– 

2009, Email: brian.altman@samhsa.gov. 

RIN: 0930–AA18 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Food and Drug Administration (FDA) 

Proposed Rule Stage 

276. Over-the-Counter (OTC) Drug 

Review—Cough/Cold (Antihistamine) 

Products 

Legal Authority: 21 U.S.C. 321p; 21 

U.S.C. 331; 21 U.S.C. 351 to 353; 21 

U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 

Abstract: FDA will be proposing a 

rule to add the common cold indication 

to certain over-the-counter (OTC) 

antihistamine active ingredients. This 

proposed rule is the result of 

collaboration under the U.S.-Canada 

Regulatory Cooperation Council (RCC) 

as part of efforts to reduce unnecessary 

duplication and differences. This pilot 

exercise will help determine the 

feasibility of developing an ongoing 

mechanism for alignment in review and 

adoption of OTC drug monograph 

elements. 

Timetable: 


tkelley on DSK3SPTVN1PROD with PROPOSALS 8
Federal Register / Vol. 79, No. 245 / Monday, December 22, 2014 / Unified Agenda 76721 

Action Date FR Cite 

Reopening of Administrative 

Record.

08/25/00 65 FR 51780 

Comment Period 

End.

11/24/00 

NPRM (Amendment) (Common 

Cold).

09/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Janice Adams-King, 

Regulatory Health Project Manager, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO 22, Room 

5416, 10903 New Hampshire Avenue, 

Silver Spring, MD 20993, Phone: 301 

796–3713, Fax: 301 796–9899, Email: 

janice.adams-king@fda.hhs.gov. 

RIN: 0910–AF31 

277. Over-the-Counter (OTC) Drug 

Review—Internal Analgesic Products 

Legal Authority: 21 U.S.C. 321p; 21 

U.S.C. 331; 21 U.S.C. 351 to 353; 21 

U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371; 

21 U.S.C. 374; 21 U.S.C. 379e 

Abstract: The OTC drug review 

establishes conditions under which 

OTC drugs are considered generally 

recognized as safe and effective, and not 

misbranded. After a final monograph 

(i.e., final rule) is issued, only OTC 

drugs meeting the conditions of the 

monograph, or having an approved new 

drug application, may be legally 

marketed. The first action addresses 

acetaminophen safety. The second 

action addresses products marketed for 

children under 2 years old and weightand age-based dosing for children’s 

products. 

Timetable: 

Action Date FR Cite 

NPRM (Amendment) (Required 

Warnings and 

Other Labeling).

12/26/06 71 FR 77314 

NPRM Comment 

Period End.

05/25/07 

Final Action (Required Warnings and Other 

Labeling).

04/29/09 74 FR 19385 

Final Action (Correction).06/30/09 74 FR 31177 

Final Action 

(Technical 

Amendment).

11/25/09 74 FR 61512 

NPRM (Amendment) (Pediatric).10/00/15 

NPRM (Amendment) (Acetaminophen).12/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Janice Adams-King, 

Regulatory Health Project Manager, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO 22, Room 

5416, 10903 New Hampshire Avenue, 

Silver Spring, MD 20993, Phone: 301 

796–3713, Fax: 301 796–9899, Email: 

janice.adams-king@fda.hhs.gov. 

RIN: 0910–AF36 

278. Over–the–Counter (OTC) Drug 

Review—Topical Antimicrobial Drug 

Products 

Legal Authority: 21 U.S.C. 321p; 21 

U.S.C. 331; 21 U.S.C. 351 to 353; 21 

U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 

Abstract: The OTC drug review 

establishes conditions under which 

OTC drugs are considered generally 

recognized as safe and effective, and not 

misbranded. After a final monograph 

(i.e., final rule) is issued, only OTC 

drugs meeting the conditions of the 

monograph, or having an approved new 

drug application, may be legally 

marketed. This action addresses 

antimicrobial agents in healthcare 

antiseptic products. 

Timetable: 

Action Date FR Cite 

NPRM 

(Healthcare).

06/17/94 59 FR 31402 

Comment Period 

End.

12/15/95 

NPRM (Consumer 

Hand Wash 

Products).

12/17/13 78 FR 76443 

NPRM 

(Healthcare Antiseptic).

04/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Janice Adams-King, 

Regulatory Health Project Manager, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO 22, Room 

5416, 10903 New Hampshire Avenue, 

Silver Spring, MD 20993, Phone: 301 

796–3713, Fax: 301 796–9899, Email: 

janice.adams-king@fda.hhs.gov. 

RIN: 0910–AF69 

279. Abbreviated New Drug 

Applications and 505(b)(2) 

Legal Authority: Pub. L. 108–173, title 

XI; 21 U.S.C. 355; 21 U.S.C. 371 

Abstract: This proposed rule would 

make changes to certain procedures for 

Abbreviated New Drug Applications 

and related applications to patent 

certifications, notice to patent owners 

and application holders, the availability 

of a 30-month stay of approval, 

amendments and supplements, and the 

types of bioavailability and 

bioequivalence data that can be used to 

support these applications. 

Timetable: 

Action Date FR Cite 

NPRM .................. 11/00/14 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Janice L. Weiner, 

Senior Regulatory Counsel, Department 

of Health and Human Services, Food 

and Drug Administration, Center for 

Drug Evaluation and Research, WO 51, 

Room 6268, 10903 New Hampshire 

Avenue, Silver Spring, MD 20993–0002, 

Phone: 301 796–3601, Fax: 301 847– 

8440, Email: janice.weiner@fda.hhs.gov. 

RIN: 0910–AF97 

280. Updated Standards for Labeling of 

Pet Food 

Legal Authority: 21 U.S.C. 343; 21 

U.S.C. 371; Pub. L. 110–85, sec 

1002(a)(3) 

Abstract: FDA is proposing updated 

standards for the labeling of pet food 

that include nutritional and ingredient 

information, as well as style and 

formatting standards. FDA is taking this 

action to provide pet owners and animal 

health professionals more complete and 

consistent information about the 

nutrient content and ingredient 

composition of pet food products. 

Timetable: 

Action Date FR Cite 

NPRM .................. 04/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: William Burkholder, 

Veterinary Medical Officer, Department 

of Health and Human Services, Food 

and Drug Administration, Center for 

Veterinary Medicine, Room 2642 (MPN– 

4, HFV–228), 7519 Standish Place, 

Rockville, MD 20855, Phone: 240 453– 

6865, Email: 

william.burkholder@fda.hhs.gov. 

RIN: 0910–AG09 

281. Current Good Manufacturing 

Practice and Hazard Analysis and RBased Preventive Controls for Food for 

Animals 

Regulatory Plan: This entry is Seq. 

No. 48 in part II of this issue of the 

Federal Register. 

RIN: 0910–AG10 


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76722 Federal Register / Vol. 79, No. 245 / Monday, December 22, 2014 / Unified Agenda 

282. Over-the-Counter (OTC) Drug 

Review—Pediatric Dosing for Cough/ 

Cold Products 

Legal Authority: 21 U.S.C. 331; 21 

U.S.C. 351 to 353; 21 U.S.C. 355; 21 

U.S.C. 360; 21 U.S.C. 371 

Abstract: The OTC drug review 

establishes conditions under which 

OTC drugs are considered generally 

recognized as safe and effective, and not 

misbranded. After a final monograph 

(i.e., final rule) is issued, only OTC 

drugs meeting the conditions of the 

monograph, or having an approved new 

drug application, may be legally 

marketed. This action will propose 

changes to the final monograph to 

address safety and efficacy issues 

associated with pediatric cough and 

cold products. 

Timetable: 

Action Date FR Cite 

NPRM .................. 10/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Janice Adams-King, 

Regulatory Health Project Manager, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO 22, Room 

5416, 10903 New Hampshire Avenue, 

Silver Spring, MD 20993, Phone: 301 

796–3713, Fax: 301 796–9899, Email: 

janice.adams-king@fda.hhs.gov. 

RIN: 0910–AG12 

283. Electronic Distribution of 

Prescribing Information for Human 

Prescription Drugs Including Biological 

Products 

Legal Authority: 21 U.S.C. 321; 21 

U.S.C. 331; 21 U.S.C. 351; 21 U.S.C. 352; 

21 U.S.C. 353; 21 U.S.C. 355; 21 U.S.C. 

358; 21 U.S.C. 360; 21 U.S.C. 360b; 21 

U.S.C. 360gg to 360ss; 21 U.S.C. 371; 21 

U.S.C. 374; 21 U.S.C. 379e; 42 U.S.C. 

216; 42 U.S.C. 241; 42 U.S.C. 262; 42 

U.S.C. 264 

Abstract: This rule would require 

electronic package inserts for human 

drug and biological prescription 

products with limited exceptions, in 

lieu of paper, which is currently used. 

These inserts contain prescribing 

information intended for healthcare 

practitioners. This would ensure that 

the information accompanying the 

product is the most up-to-date 

information regarding important safety 

and efficacy issues about these 

products. 

Timetable: 

Action Date FR Cite 

NPRM .................. 11/00/14 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Megan Velez, Policy 

Analyst, Department of Health and 

Human Services, Food and Drug 

Administration, Office of Policy, WO 

32, Room 4249, 10903 New Hampshire 

Avenue, Silver Spring, MD 20993, 

Phone: 301 796–9301, Email: 

megan.velez@fda.hhs.gov. 

RIN: 0910–AG18 

284. Standards for the Growing, 

Harvesting, Packing, and Holding of 

Produce for Human Consumption 

Regulatory Plan: This entry is Seq. 

No. 49 in part II of this issue of the 

Federal Register. 

RIN: 0910–AG35 

285. Current Good Manufacturing and 

Hazard Analysis, and Risk-Based 

Preventive Controls for Human Food 

Regulatory Plan: This entry is Seq. 

No. 50 in part II of this issue of the 

Federal Register. 

RIN: 0910–AG36 

286. Requirements for the Testing and 

Reporting of Tobacco Product 

Constituents, Ingredients, and 

Additives 

Legal Authority: 21 U.S.C. 301 et seq.; 

21 U.S.C. 387; The Family Smoking 

Prevention and Tobacco Control Act 

Abstract: The Federal Food, Drug, and 

Cosmetic Act, as amended by the 

Family Smoking Prevention and 

Tobacco Control Act, requires the Food 

and Drug Administration to promulgate 

regulations that require the testing and 

reporting of tobacco product 

constituents, ingredients, and additives, 

including smoke constituents, that the 

Agency determines should be tested to 

protect the public health. 

Timetable: 

Action Date FR Cite 

NPRM .................. 05/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Carol Drew, 

Regulatory Counsel, Department of 

Health and Human Services, Food and 

Drug Administration, Center for 

Tobacco Products, Document Control 

Center, Building 71, Room G335, 10903 

New Hampshire Avenue, Silver Spring, 

MD 20993, Phone: 877 287–1373, Fax: 

301 595–1426, Email: 

ctpregulations@fda.hhs.gov. 

RIN: 0910–AG59 

287. Foreign Supplier Verification 

Program 

Regulatory Plan: This entry is Seq. 

No. 52 in part II of this issue of the 

Federal Register. 

RIN: 0910–AG64 

288. Format and Content of Reports 

Intended to Demonstrate Substantial 

Equivalence 

Legal Authority: 21 U.S.C. 387e(j); 21 

U.S.C. 387j(a); secs 905(j) and 910(a) of 

the Federal Food, Drug, and Cosmetic 

Act 

Abstract: This regulation would 

establish the format and content of 

reports intended to demonstrate 

substantial equivalence. This regulation 

also would provide information as to 

how the Agency will review and act on 

these submissions. 

Timetable: 

Action Date FR Cite 

NPRM .................. 07/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Gerie Voss, 

Regulatory Counsel, Department of 

Health and Human Services, Food and 

Drug Administration, Center for 

Tobacco Products, Document Control 

Center, Bldg. 71, Rm. G335, 10903 New 

Hampshire Ave., Silver Spring, MD 

20993, Phone: 877 287–1373, Fax: 301 

595–1426, Email: 

ctpregulations@fda.hhs.gov. 

RIN: 0910–AG96 

289. Food Labeling; Gluten-Free 

Labeling of Fermented, Hydrolyzed, or 

Distilled Foods 

Legal Authority: Sec 206 of the Food 

Allergen Labeling and Consumer 

Protection Act; 21 U.S.C. 343(a)(1); 21 

U.S.C. 321(n); 21 U.S.C. 371(a) 

Abstract: This proposed rule would 

establish requirements concerning 

compliance for using a ‘‘gluten-free’’ 

labeling claim for those foods for which 

there is no scientifically valid analytical 

method available that can reliably detect 

and accurately quantify the presence of 

20 parts per million (ppm) gluten in the 

food. 

Timetable: 

Action Date FR Cite 

NPRM .................. 01/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Felicia Billingslea, 

Director, Food Labeling and Standard 

Staff, Department of Health and Human 

Services, Food and Drug 


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Administration, Room 4D045, HFS 820, 

5100 Paint Branch Parkway, College 

Park, MD 20740, Phone: 240 402–1803, 

Fax: 301 436–2636, Email: 

felicia.billingslea@fda.hhs.gov. 

RIN: 0910–AH00 

290. Radiology Devices; Designation of 

Special Controls for the Computed 

Tomography X-Ray System 

Legal Authority: 21 U.S.C. 360c 

Abstract: The proposed rule would 

establish special controls for the 

computed tomography (CT) X-ray 

system. A CT X-ray system is a 

diagnostic X-ray imaging system 

intended to produce cross-sectional 

images of the body through use of a 

computer to reconstruct an image from 

the same axial plane taken at different 

angles. High doses of ionizing radiation 

can cause acute (deterministic) effects 

such as burns, reddening of the skin, 

cataracts, hair loss, sterility, and, in 

extremely high doses, radiation 

poisoning. The design of a CT X-ray 

system should balance the benefits of 

the device (i.e., the ability of the device 

to produce a diagnostic quality image) 

with the known risks (e.g., exposure to 

ionizing radiation). FDA is establishing 

proposed special controls, which, when 

combined with the general controls, 

would provide reasonable assurance of 

the safety and effectiveness of a class II 

CT X-ray system. 

Timetable: 

Action Date FR Cite 

NPRM .................. 09/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Erica Blake, 

Regulatory Counsel, Department of 

Health and Human Services, Food and 

Drug Administration, Center for Devices 

and Radiological Health, WO 66, Room 

4426, 10903 New Hampshire Avenue, 

Silver Spring, MD 20993, Phone: 301 

796–6248, Fax: 301 847–8145, Email: 

erica.blake@fda.hhs.gov. 

RIN: 0910–AH03 

291. Mammography Quality Standards 

Act; Regulatory Amendments 

Legal Authority: 21 U.S.C. 360i; 21 

U.S.C. 360nn; 21 U.S.C. 374(e); 42 

U.S.C. 263b 

Abstract: FDA is proposing to amend 

its regulations governing 

mammography. The amendments would 

update the regulations issued under the 

Mammography Quality Standards Act of 

1992 (MQSA). FDA is taking this action 

to address changes in mammography 

technology and mammography 

processes, such as breast density 

reporting, that have occurred since the 

regulations were published in 1997. 

Timetable: 

Action Date FR Cite 

NPRM .................. 04/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Nancy Pirt, 

Regulatory Counsel, Department of 

Health and Human Services, Food and 

Drug Administration, Center for Devices 

and Radiological Health, WO 66, Room 

4438, 10903 New Hampshire Avenue, 

Silver Spring, MD 20993, Phone: 301 

796–6248, Fax: 301 847–8145, Email: 

nancy.pirt@fda.hhs.gov. 

RIN: 0910–AH04 

292. Investigational New Drug 

Application Annual Reporting 

Legal Authority: 21 U.S.C. 355(i); 21 

U.S.C. 371(a) 

Abstract: This proposed rule would 

revise the requirements concerning 

annual reports submitted to 

investigational new drug applications 

(INDs) by replacing the current annual 

reporting requirement with a 

requirement that is consistent with the 

format, content, and timing of 

submission of the development safety 

update report devised by the 

International Conference on 

Harmonization of Technical 

Requirements for Registration of 

Pharmaceuticals for Human Use (ICH). 

Timetable: 

Action Date FR Cite 

NPRM .................. 09/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Peter A. 

Taschenberger, Regulatory Counsel, 

Department of Health and Human 

Services, Food and Drug 

Administration, 10903 New Hampshire 

Avenue, Building 51, Room 6312, Silver 

Spring, MD 20993, Phone: 301 796– 

0018, Fax: 301 847–3529, Email: 

peter.taschenberger@fda.hhs.gov. 

RIN: 0910–AH07 

293. General and Plastic Surgery 

Devices: Sunlamp Products 

Legal Authority: 21 U.S.C. 360j(e) 

Abstract: This proposed rule would 

apply device restrictions to sunlamp 

products. 

Timetable: 

Action Date FR Cite 

NPRM .................. 03/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Paul Gadiock, 

Regulatory Counsel, Department of 

Health and Human Services, Food and 

Drug Administration, 10903 New 

Hampshire Avenue, W0–66, Room 4432, 

Silver Spring, MD 20993–0002, Phone: 

301 796–5736, Fax: 301 847–8145, 

Email: paul.gadiock@fda.hhs.gov. 

RIN: 0910–AH14 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Food and Drug Administration (FDA) 

Final Rule Stage 

294. Requirements for Foreign and 

Domestic Establishment Registration 

and Listing for Human Drugs, Including 

Drugs That Are Regulated Under a 

Biologics License Application, and 

Animal Drugs 

Legal Authority: 21 U.S.C. 321 and 

331; 21 U.S.C. 351 to 353; 21 U.S.C. 355 

to 356c; 21 U.S.C. 360 and 360b; 21 

U.S.C. 360c to 360f; 21 U.S.C. 360h to 

360j; 21 U.S.C. 371 and 374; 21 U.S.C. 

379e and 381; 21 U.S.C. 393; 15 U.S.C. 

1451 to 1561; 42 U.S.C. 262 and 264; 42 

U.S.C. 271 

Abstract: The rule will reorganize, 

consolidate, clarify, and modify current 

regulations concerning who must 

register establishments and list human 

drugs, including certain biological 

drugs, and animal drugs. These 

regulations contain information on 

when, how, and where to register drug 

establishments and list drugs, and what 

information must be submitted. They 

also address National Drug Codes. 

Timetable: 

Action Date FR Cite 

NPRM .................. 08/29/06 71 FR 51276 

NPRM Comment 

Period End.

02/26/07 

Final Action ......... 10/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: David Joy, Senior 

Regulatory Counsel, Department of 

Health and Human Services, Food and 

Drug Administration, WO 51, Room 

6254, 10903 New Hampshire Avenue, 

Silver Spring, MD 20993, Phone: 301 

796–2242, Email: david.joy@

fda.hhs.gov. 

RIN: 0910–AA49 


tkelley on DSK3SPTVN1PROD with PROPOSALS 8
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295. Content and Format of Labeling for 

Human Prescription Drugs and 

Biologics; Requirements for Pregnancy 

and Lactation Labeling 

Legal Authority: 21 U.S.C. 321; 21 

U.S.C. 331; 21 U.S.C. 351 to 353; 21 

U.S.C. 355; 21 U.S.C. 358; 21 U.S.C. 360; 

21 U.S.C. 360b; 21 U.S.C. 360gg to 

360ss; 21 U.S.C. 371; 21 U.S.C. 374; 21 

U.S.C. 379e; 42 U.S.C. 216; 42 U.S.C. 

241; 42 U.S.C. 262; 42 U.S.C. 264 

Abstract: This final rule will amend 

the content and format of the 

‘‘Pregnancy,’’ ‘‘Labor and delivery,’’ and 

‘‘Nursing mothers’’ subsections of the 

‘‘Use in Specific Populations’’ section of 

regulations regarding the labeling for 

human prescription drug and biological 

products to better communicate risks. 

Timetable: 

Action Date FR Cite 

NPRM .................. 05/29/08 73 FR 30831 

NPRM Comment 

Period End.

08/27/08 

Final Action ......... 11/00/14 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Kathy Schreier, 

Regulatory Counsel, Department of 

Health and Human Services, Food and 

Drug Administration, Center for Drug 

Evaluation and Research, 10903 New 

Hampshire Ave., WO51, Rm. 6246, 

Silver Spring, MD 20993, Phone: 301 

796–3432, Email: kathy.schreier@

fda.hhs.gov. 

RIN: 0910–AF11 

296. Combinations of Bronchodilators 

With Nasal Decongestant; Cold, Cough, 

Allergy, Bronchodilator, and 

Antiasthmatic Drug Products for Overthe-Counter Human Use 

Legal Authority: 21 U.S.C. 321p; 21 

U.S.C. 331; 21 U.S.C. 351 to 353; 21 

U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 

Abstract: The OTC drug review 

establishes conditions under which 

OTC drugs are considered generally 

recognized as safe and effective, and not 

misbranded. After a final monograph 

(i.e., final rule) is issued, only OTC 

drugs meeting the conditions of the 

monograph, or having an approved new 

drug application, may be legally 

marketed. These actions address cough/ 

cold drug products containing an oral 

bronchodilator (ephedrine and its salts) 

in combination with any oral nasal 

decongestant. 

Timetable: 

Action Date FR Cite 

NPRM (Amendment).07/13/05 70 FR 40232 

Action Date FR Cite 

NPRM Comment 

Period End.

11/10/05 

Final Action 

(Technical 

Amendment).

03/19/07 72 FR 12730 

Final Action (Oral 

Bronchodilator 

& Oral Nasal 

Decongestant).

07/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Janice Adams-King, 

Regulatory Health Project Manager, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO 22, Room 

5416, 10903 New Hampshire Avenue, 

Silver Spring, MD 20993, Phone: 301 

796–3713, Fax: 301 796–9899, Email: 

janice.adams-king@fda.hhs.gov. 

RIN: 0910–AF33 

297. Over-the-Counter (OTC) Drug 

Review—Laxative Drug Products 

Legal Authority: 21 U.S.C. 321p; 21 

U.S.C. 331; 21 U.S.C. 351 to 353; 21 

U.S.C. 355; 21 U.S.C. 360 to 360a; 21 

U.S.C. 371 to 371a 

Abstract: The OTC drug review 

establishes conditions under which 

OTC drugs are considered generally 

recognized as safe and effective, and not 

misbranded. After a final monograph 

(i.e., final rule) is issued, only OTC 

drugs meeting the conditions of the 

monograph, or having an approved new 

drug application, may be legally 

marketed. The final rule listed will 

address the professional labeling for 

sodium phosphate drug products. 

Timetable: 

Action Date FR Cite 

Final Action 

(Granular Psyllium).

03/29/07 72 FR 14669 

NPRM (Professional Labeling—Sodium 

Phosphate).

02/11/11 76 FR 7743 

NPRM Comment 

Period End.

03/14/11 

Final Action (Professional Labeling—Sodium 

Phosphate).

10/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Janice Adams-King, 

Regulatory Health Project Manager, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO 22, Room 

5416, 10903 New Hampshire Avenue, 

Silver Spring, MD 20993, Phone: 301 

796–3713, Fax: 301 796–9899, Email: 

janice.adams-king@fda.hhs.gov. 

RIN: 0910–AF38 

298. Laser Products; Amendment to 

Performance Standard 

Legal Authority: 21 U.S.C. 360hh to 

360ss; 21 U.S.C. 371; 21 U.S.C. 393 

Abstract: The regulation will amend 

the performance standard for laser 

products to achieve closer 

harmonization between the current 

standard and the International 

Electrotechnical Commission (IEC) 

standard for laser products and medical 

laser products. The amendment is 

intended to update FDA’s performance 

standard to reflect advancements in 

technology. 

Timetable: 

Action Date FR Cite 

NPRM .................. 06/24/13 78 FR 37723 

NPRM Comment 

Period End.

09/23/13 

Final Action ......... 10/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Nancy Pirt, 

Regulatory Counsel, Department of 

Health and Human Services, Food and 

Drug Administration, Center for Devices 

and Radiological Health, WO 66, Room 

4438, 10903 New Hampshire Avenue, 

Silver Spring, MD 20993, Phone: 301 

796–6248, Fax: 301 847–8145, Email: 

nancy.pirt@fda.hhs.gov. 

RIN: 0910–AF87 

299. ‘‘Tobacco Products’’ Subject to the 

Federal Food, Drug, and Cosmetic Act, 

as Amended by the Family Smoking 

Prevention and Tobacco Control Act 

Regulatory Plan: This entry is Seq. 

No. 53 in part II of this issue of the 

Federal Register. 

RIN: 0910–AG38 

300. Human Subject Protection; 

Acceptance of Data From Clinical 

Investigations for Medical Devices 

Legal Authority: 21 U.S.C. 321; 21 

U.S.C. 331; 21 U.S.C. 351; 21 U.S.C. 352; 

21 U.S.C. 360; 21 U.S.C. 360c; 21 U.S.C. 

360e; 21 U.S.C. 360i; 21 U.S.C. 360j; 21 

U.S.C. 371; 21 U.S.C. 374; 21 U.S.C. 381; 

21 U.S.C. 393; 42 U.S.C. 264; 42 U.S.C. 

271; . . . 

Abstract: This rule will amend FDA’s 

regulations on acceptance of data from 

clinical investigations for medical 

devices to require that clinical 

investigations conducted outside the 

United States in support of a premarket 

approval application, humanitarian 

device exemption application, an 

investigational device exemption 


tkelley on DSK3SPTVN1PROD with PROPOSALS 8
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application, or a premarket notification 

submission be conducted in accordance 

with good clinical practice. 

Timetable: 

Action Date FR Cite 

NPRM .................. 02/25/13 78 FR 12664 

NPRM Comment 

Period End.

05/28/13 

Final Action ......... 01/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Sheila Anne Brown, 

Policy Analyst, Investigational Device 

Exemptions Staff, Department of Health 

and Human Services, Food and Drug 

Administration, WO 66, Room 1651, 

10903 New Hampshire Avenue, Silver 

Spring, MD 20993, Phone: 301 796– 

6563, Fax: 301 847–8120, Email: 

sheila.brown@fda.hhs.gov. 

RIN: 0910–AG48 

301. Food Labeling: Calorie Labeling of 

Articles of Food Sold in Vending 

Machines 

Regulatory Plan: This entry is Seq. 

No. 54 in part II of this issue of the 

Federal Register. 

RIN: 0910–AG56 

302. Food Labeling: Nutrition Labeling 

of Standard Menu Items in Restaurants 

and Similar Retail Food Establishments 

Regulatory Plan: This entry is Seq. 

No. 55 in part II of this issue of the 

Federal Register. 

RIN: 0910–AG57 

303. Supplemental Applications 

Proposing Labeling Changes for 

Approved Drugs and Biological 

Products 

Regulatory Plan: This entry is Seq. 

No. 58 in part II of this issue of the 

Federal Register. 

RIN: 0910–AG94 

304. Veterinary Feed Directive 

Regulatory Plan: This entry is Seq. 

No. 59 in part II of this issue of the 

Federal Register. 

RIN: 0910–AG95 

305. • Combinations of Bronchodilators 

With Expectorants; Cold, Cough, 

Allergy, Bronchodilator, and 

Antiasthmatic Drug Products for Overthe-Counter Human Use 

Legal Authority: 21 U.S.C. 321p; 21 

U.S.C. 331; 21 U.S.C. 351 to 353; 21 

U.S.C. 355; 21 U.S.C. 360; 21 U.S.C. 371 

Abstract: The OTC drug review 

establishes conditions under which 

OTC drugs are considered generally 

recognized as safe and effective, and not 

misbranded. After a final monograph 

(i.e. final rule) is issued, only OTC drugs 

meeting the conditions of the 

monograph, or having an approved new 

drug application, may be legally 

marketed. These actions address cough/ 

cold drug products containing an oral 

bronchodilator (ephedrine and its salts) 

in combination with any expectorant. 

Timetable: 

Action Date FR Cite 

NPRM (Amendment).07/13/05 70 FR 40232 

NPRM Comment 

Period End.

11/10/05 

Final Action 

(Technical 

Amendment).

03/19/07 72 FR 12730 

Final Action ......... 07/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Janice Adams-King, 

Regulatory Health Project Manager, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Drug 

Evaluation and Research, WO 22, Room 

5416, 10903 New Hampshire Avenue, 

Silver Spring, MD 20993, Phone: 301 

796–3713, Fax: 301 796–9899, Email: 

janice.adams-king@fda.hhs.gov. 

RIN: 0910–AH16 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Food and Drug Administration (FDA) 

Long-Term Actions 

306. Food Labeling; Revision of the 

Nutrition and Supplement Facts Labels 

Legal Authority: 21 U.S.C. 321; 21 

U.S.C. 343; 21 U.S.C. 371 

Abstract: FDA is amending the 

labeling regulations for conventional 

foods and dietary supplements to 

provide updated nutrition information 

on the label to assist consumers in 

maintaining healthy dietary practices. 

This rule will modernize the nutrition 

information found on the Nutrition 

Facts label, as well as the format and 

appearance of the label. 

Timetable: 

Action Date FR Cite 

ANPRM ............... 07/11/03 68 FR 41507 

ANPRM Comment 

Period End.

10/09/03 

Second ANPRM .. 04/04/05 70 FR 17008 

Second ANPRM 

Comment Period End.

06/20/05 

Third ANPRM ...... 11/02/07 72 FR 62149 

Third ANPRM 

Comment Period End.

01/31/08 

NPRM .................. 03/03/14 79 FR 11879 

Action Date FR Cite 

NPRM Comment 

Period End.

06/02/14 

Final Action ......... 03/00/16 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Blakeley Fitzpatrick, 

Interdisciplinary Scientist, Department 

of Health and Human Services, Food 

and Drug Administration, Center for 

Food Safety and Applied Nutrition 

(HFS–830), HFS–830, 5100 Paint Branch 

Parkway, College Park, MD 20740, 

Phone: 240 402–5429, Email: 

nutritionprogramstaff@fda.hhs.gov. 

RIN: 0910–AF22 

307. Food Labeling: Serving Sizes of 

Foods That Can Reasonably Be 

Consumed at One-Eating Occasion; 

Dual-Column Labeling; Updating, 

Modifying, and Establishing Certain 

RACCs 

Legal Authority: 21 U.S.C. 321; 21 

U.S.C. 343; 21 U.S.C. 371 

Abstract: FDA is amending its 

labeling regulations for foods to provide 

updated Reference Amounts 

Customarily Consumed (RACCs) for 

certain food categories. This rule would 

provide consumers with nutrition 

information based on the amount of 

food that is customarily consumed, 

which would assist consumers in 

maintaining healthy dietary practices. In 

addition to updating certain RACCs, 

FDA is also amending the definition of 

single-serving containers; amending the 

label serving size for breath mints; and 

providing for dual-column labeling, 

which would provide nutrition 

information per serving and per 

container or unit, as applicable, under 

certain circumstances. 

Timetable: 

Action Date FR Cite 

ANPRM ............... 04/04/05 70 FR 17010 

ANPRM Comment 

Period End.

06/20/05 

NPRM .................. 03/03/14 79 FR 11989 

NPRM Comment 

Period End.

06/02/14 

Final Action ......... 03/00/16 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Cherisa Henderson, 

Nutritionist, Department of Health and 

Human Services, Food and Drug 

Administration, HFS–830, 5100 Paint 

Branch Parkway, College Park, MD 

20740, Phone: 240 402–5429, Fax: 301 

436–1191, Email: 

nutritionprogramstaff@fda.hhs.gov. 

RIN: 0910–AF23 


tkelley on DSK3SPTVN1PROD with PROPOSALS 8
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308. Focused Mitigation Strategies To 

Protect Food Against Intentional 

Adulteration 

Legal Authority: 21 U.S.C. 331; 21 

U.S.C. 342; 21 U.S.C. 350g; 21 U.S.C. 

350i; 21 U.S.C. 371; 21 U.S.C. 374; Pub. 

L. 111–353 

Abstract: This rule would require 

domestic and foreign food facilities that 

are required to register under the 

Federal Food, Drug, and Cosmetic Act to 

address hazards that may be 

intentionally introduced by acts of 

terrorism. These food facilities would be 

required to identify and implement 

focused mitigation strategies to 

significantly minimize or prevent 

significant vulnerabilities identified at 

actionable process steps in a food 

operation. 

Timetable: 

Action Date FR Cite 

NPRM .................. 12/24/13 78 FR 78014 

NPRM Comment 

Period Extended.

03/25/14 79 FR 16251 

NPRM Comment 

Period End.

03/31/14 

NPRM Comment 

Period Extended End.

06/30/14 

Final Rule ............ 05/00/16 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Jody Menikheim, 

Supervisory General Health Scientist, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Food Safety 

and Applied Nutrition (HFS–005), 5100 

Paint Branch Parkway, College Park, MD 

20740, Phone: 240 402–1864, Fax: 301 

436–2633, Email: fooddefense@

fda.hhs.gov. 

RIN: 0910–AG63 

309. Sanitary Transportation of Human 

and Animal Food 

Legal Authority: 21 U.S.C. 350e; 21 

U.S.C. 373; 21 U.S.C. 331; 21 U.S.C. 342; 

21 U.S.C. 371; . . . 

Abstract: This rule would establish 

requirements for shippers, carriers by 

motor vehicle or rail vehicle, and 

receivers engaged in the transportation 

of food, including food for animals, to 

use sanitary transportation practices to 

ensure that food is not transported 

under conditions that may render the 

food adulterated. 

Timetable: 

Action Date FR Cite 

ANPRM ............... 04/30/10 75 FR 22713 

ANPRM Comment 

Period End.

08/30/10 

Action Date FR Cite 

NPRM .................. 02/05/14 79 FR 7005 

NPRM Comment 

Period Extended.

05/23/14 79 FR 29699 

NPRM Comment 

Period End.

05/31/14 

NPRM Comment 

Period Extended End.

07/30/14 

Final Rule ............ 03/00/16 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Michael E. Kashtock, 

Supervisory Consumer Safety Officer, 

Department of Health and Human 

Services, Food and Drug 

Administration, Center for Food Safety 

and Applied Nutrition, Office of Food 

Safety, 5100 Paint Branch Parkway, 

College Park, MD 20740, Phone: 240 

402–2022, Fax: 301 346–2632, Email: 

michael.kashtock@fda.hhs.gov. 

RIN: 0910–AG98 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Food and Drug Administration (FDA) 

Completed Actions 

310. Infant Formula: Current Good 

Manufacturing Practices; Quality 

Control Procedures; Notification 

Requirements; Records And Reports; 

and Quality Factors 

Legal Authority: 21 U.S.C. 321; 21 

U.S.C. 342; 21 U.S.C. 350a; 21 U.S.C. 

371 

Abstract: The Food and Drug 

Administration (FDA) is revising its 

infant formula regulations to establish 

requirements for current good 

manufacturing practices (CGMP), 

including audits; to establish 

requirements for quality factors; and to 

amend FDA’s quality control 

procedures, notification, and record and 

reporting requirements for infant 

formula. FDA is taking this action to 

improve the protection of infants who 

consume infant formula products. 

Timetable: 

Action Date FR Cite 

NPRM .................. 07/09/96 61 FR 36154 

NPRM Comment 

Period End.

12/06/96 

NPRM Comment 

Period Reopened.

04/28/03 68 FR 22341 

NPRM Comment 

Period Extended.

06/27/03 68 FR 38247 

NPRM Comment 

Period End.

08/26/03 

Action Date FR Cite 

NPRM Comment 

Period Reopened.

08/01/06 71 FR 43392 

NPRM Comment 

Period End.

09/15/06 

Interim Final Rule 02/10/14 79 FR 7934 

Interim Final Rule 

Comment Period End.

03/27/14 

Final Action ......... 06/10/14 79 FR 33057 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Leila Beker, 

Biologist, Department of Health and 

Human Services, Food and Drug 

Administration, Center for Food Safety 

and Applied Nutrition (HFS–850), 5100 

Paint Branch Parkway, College Park, MD 

20740, Phone: 240 402–1451, Email: 

leila.beker@fda.hhs.gov. 

RIN: 0910–AF27 

311. Postmarketing Safety Reports for 

Human Drug and Biological Products: 

Electronic Submission Requirements 

Legal Authority: 21 U.S.C. 321; 21 

U.S.C. 331; 21 U.S.C. 351 to 353; 21 

U.S.C. 355 to 355a; 21 U.S.C. 356 to 

356c; 21 U.S.C. 360; 21 U.S.C. 371; 21 

U.S.C. 374; 21 U.S.C. 375; 21 U.S.C. 

379k–l; 21 U.S.C. 379aa; 21 U.S.C. 381; 

42 U.S.C. 241; 42 U.S.C. 262; 42 U.S.C. 

264; . . . 

Abstract: The final rule would amend 

FDA’s postmarketing safety reporting 

regulations for human drug and 

biological products to require that 

mandatory safety reports submitted to 

the Agency be transmitted in an 

electronic format that FDA can process, 

review, and archive. The rule will allow 

the Agency to review safety reports 

more quickly, to identify emerging 

safety problems, and disseminate safety 

information more rapidly in support of 

FDA’s public health mission. The 

amendments also would be a key 

element in harmonizing FDA’s 

postmarketing safety reporting 

regulations with international and 

International Harmonization Standards 

standards for the electronic submission 

of safety information. 

Timetable: 

Action Date FR Cite 

ANPRM ............... 11/05/98 63 FR 59746 

ANPRM Comment 

Period End.

02/03/99 

NPRM .................. 08/21/09 74 FR 42184 

NPRM Comment 

Period End.

11/19/09 

Final Action ......... 06/10/14 79 FR 33072 

Regulatory Flexibility Analysis 

Required: Yes. 


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Agency Contact: Reena Raman, 

Regulatory Counsel, Department of 

Health and Human Services, Food and 

Drug Administration, Center for Drug 

Evaluation and Research, WO 51, Room 

6238, 10903 New Hampshire Avenue, 

Silver Spring, MD 20993–0002, Phone: 

301 796–7577, Fax: 301 847–8440, 

Email: reena.raman@fda.hhs.gov. 

RIN: 0910–AF96 

312. Requirements for the Submission 

of Data Needed To Calculate User Fees 

for Domestic Manufacturers and 

Importers of Tobacco Products 

Legal Authority: 21 U.S.C. 371; 21 

U.S.C. 387s; Pub. L. 111–31 

Abstract: This rule will require 

manufacturers and importers of tobacco 

products to submit certain market share 

data to FDA. USDA currently collects 

such data, but its program sunsets at the 

end of September 2014, and USDA will 

cease collection of this information. 

FDA is taking this action so that it may 

continue to calculate market share 

percentages needed to compute user 

fees. 

Timetable: 

Action Date FR Cite 

NPRM .................. 05/31/13 78 FR 32581 

NPRM Comment 

Period End.

08/14/13 

Final Action ......... 07/10/14 79 FR 39302 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Annette L. Marthaler, 

Regulatory Counsel, Department of 

Health and Human Services, Food and 

Drug Administration, Center for 

Tobacco Products, Document Control 

Center, Building 71, Room G335, 10903 

New Hampshire Avenue, Silver Spring, 

MD 20993, Phone: 877 287–1373, Fax: 

877 287–1426, Email: ctpregulations@

fda.hhs.gov. 

RIN: 0910–AG81 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Centers for Medicare & Medicaid 

Services (CMS) 

Proposed Rule Stage 

313. Home Health Agency Conditions of 

Participation (CMS–3819–F) 

(Rulemaking Resulting From a Section 

610 Review) 

Legal Authority: 42 U.S.C. 1302; 42 

U.S.C. 1395x; 42 U.S.C. 1395cc(a); 42 

U.S.C. 1395hh; 42 U.S.C. 1395bb 

Abstract: This final rule revises the 

existing Conditions of Participation that 

Home Health Agencies must meet to 

participate in the Medicare program. 

The new requirements focus on the 

actual care delivered to patients by 

HHAs, reflect an interdisciplinary view 

of patient care, allow HHAs greater 

flexibility in meeting quality standards, 

and eliminate unnecessary procedural 

requirements. These changes are an 

integral part of our efforts to improve 

patient safety and achieve broad-based 

improvements in the quality of care 

furnished through Federal programs, 

while at the same time reducing 

procedural burdens on providers. 

Timetable: 

Action Date FR Cite 

NPRM .................. 03/10/97 62 FR 11005 

NPRM Comment 

Period End.

06/09/97 

Second NPRM .... 10/09/14 79 FR 61163 

Second NPRM 

Comment Period End.

12/08/14 

Final Action ......... 10/00/17 

Regulatory Flexibility Analysis 

Required: No. 

Agency Contact: Danielle Shearer, 

Health Insurance Specialist, Department 

of Health and Human Services, Centers 

for Medicare & Medicaid Services, 

Center for Clinical Standards & Quality, 

MS: S3–02–01, 7500 Security 

Boulevard, Baltimore, MD 21244, 

Phone: 410 786–6617, Email: 

danielle.shearer@cms.hhs.gov. 

RIN: 0938–AG81 

314. Reform of Requirements for LongTerm Care Facilities (CMS–3260–P) 

(Rulemaking Resulting From a Section 

610 Review) 

Regulatory Plan: This entry is Seq. 

No. 60 in part II of this issue of the 

Federal Register. 

RIN: 0938–AR61 

315. Medicare Shared Savings Program; 

Accountable Care Organizations (CMS– 

1461–P) (Section 610 Review) 

Legal Authority: PL–111–148, sec 

3022 

Abstract: This proposed rule 

addresses changes to the Medicare 

Shared Savings Program (Shared 

Savings Program), including provisions 

relating to the payment of Accountable 

Care Organizations (ACOs) participating 

in the Shared Savings Program. Under 

the Shared Savings Program, providers 

of services and suppliers that participate 

in an ACO continue to receive 

traditional Medicare fee for service 

(FFS) payments under Parts A and B 

and are eligible for additional payments 

from the ACO if they meet specified 

quality and savings requirements. 

Timetable: 

Action Date FR Cite 

NPRM .................. 11/00/14 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Terri Postma, 

Medical Officer, Department of Health 

and Human Services, Centers for 

Medicare & Medicaid Services, Mail 

Stop C5–15–24, 7500 Security 

Boulevard, Baltimore, MD 21244, 

Phone: 410 786–4169, Email: 

terri.postma@cms.hhs.gov. 

RIN: 0938–AS06 

316. Hospital and Critical Access 

Hospital (CAH) Changes To Promote 

Innovation, Flexibility, and 

Improvement in Patient Care (CMS– 

3295–P) (Rulemaking Resulting From a 

Section 610 Review) 

Legal Authority: 42 U.S.C. 1302; 42 

U.S.C. 1395hh and 1395rr 

Abstract: This proposed rule would 

update the requirements that hospitals 

and CAHs must meet to participate in 

the Medicare and Medicaid programs. 

These proposals are intended to 

conform the requirements to current 

standards of practice and support 

improvements in quality of care, reduce 

barriers to care, and reduce some issues 

that may exacerbate workforce shortage 

concerns. 

Timetable: 

Action Date FR Cite 

NPRM .................. 03/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: CDR Scott Cooper, 

Senior Technical Advisor, Department 

of Health and Human Services, Centers 

for Medicare & Medicaid Services, 

Center for Clinical Standards and 

Quality, Mail Stop S3–01–02, 7500 

Security Boulevard, Baltimore, MD 

21244, Phone: 410 786–9465, Email: 

scott.cooper@cms.hhs.gov. 

RIN: 0938–AS21 

317. • Medicare Clinical Diagnostic 

Laboratory Test Payment System (CMS– 

1621–P) 

Legal Authority: Pub. L. 113–93, sec 

216 

Abstract: Under section 216 of the 

Protecting Access to Medicare Act of 

2014, this proposed rule would require 

Medicare payment for clinical 

laboratory tests to be based on private 

payor rates beginning January 1, 2017. 

Beginning January 1, 2016, and every 3 

years thereafter (or, annually, for certain 

laboratory tests), applicable laboratories 

must report to CMS the amount they are 


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76728 Federal Register / Vol. 79, No. 245 / Monday, December 22, 2014 / Unified Agenda 

paid by each private payor for a test, 

and the volume of such tests performed 

for each such payer for the period. The 

payment rate reported by a laboratory 

must reflect all discounts, rebates, 

coupons, and other price concessions. 

Timetable: 

Action Date FR Cite 

NPRM .................. 12/00/14 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Anne Hauswald, 

Director, Division of Ambulatory 

Services, Department of Health and 

Human Services, Centers for Medicare & 

Medicaid Services, Center for Medicare, 

Mail Stop C4–01–26, 7500 Security 

Blvd., Baltimore, MD 21244, Phone: 410 

786–4546, Email: anne-etayloe.hauswald@cms.hhs.gov. 

Valerie Miller, Deputy Director, 

Division of Ambulatory Services, 

Department of Health and Human 

Services, Centers for Medicare & 

Medicaid Services, Center for Medicare, 

Mail Stop C4–01–26, 7500 Security 

Boulevard, Baltimore, MD 21244, 

Phone: 410 786–4535, Email: 

valerie.miller@cms.hhs.gov. 

RIN: 0938–AS33 

318. • CY 2016 Revisions to Payment 

Policies Under the Physician Fee 

Schedule and Other Revisions to 

Medicare Part B (CMS–1631–P) 

Regulatory Plan: This entry is Seq. 

No. 63 in part II of this issue of the 

Federal Register. 

RIN: 0938–AS40 

319. • Hospital Inpatient Prospective 

Payment System for Acute Care 

Hospitals and the Long-Term Care 

Hospital Prospective Payment System 

and FY 2016 Rates (CMS–1632–P) 

Regulatory Plan: This entry is Seq. 

No. 64 in part II of this issue of the 

Federal Register. 

RIN: 0938–AS41 

320. • CY 2016 Hospital Outpatient 

PPS Policy Changes and Payment Rates 

and Ambulatory Surgical Center 

Payment System Policy Changes and 

Payment Rates (CMS–1633–P) 

Regulatory Plan: This entry is Seq. 

No. 65 in part II of this issue of the 

Federal Register. 

RIN: 0938–AS42 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Centers for Medicare & Medicaid 

Services (CMS) 

321. Covered Outpatient Drugs (CMS– 

2345–F) (Section 610 Review) 

Legal Authority: Pub. L. 111– 48, secs 

2501, 2503, 3301(d)(2); Pub. L. 111–152, 

sec 1206; Pub. L. 111–8, sec 221 

Abstract: This final rule revises 

requirements pertaining to Medicaid 

reimbursement for covered outpatient 

drugs to implement provisions of the 

Affordable Care Act. This rule also 

revises other requirements related to 

covered outpatient drugs, including key 

aspects of Medicaid coverage, payment, 

and the drug rebate program. 

Timetable: 

Action Date FR Cite 

NPRM .................. 02/02/12 77 FR 5318 

NPRM Comment 

Period End.

04/02/12 

Final Action ......... 04/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Wendy Tuttle, 

Health Insurance Specialist, Department 

of Health and Human Services, Centers 

for Medicare & Medicaid Services, 

Center for Medicaid and State 

Operations, Mail Stop S2–14–26, 7500 

Security Boulevard, Baltimore, MD 

21244, Phone: 410 786–8690, Email: 

wendy.tuttle@cms.hhs.gov. 

RIN: 0938–AQ41 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Centers for Medicare & Medicaid 

Services (CMS) 

Long-Term Actions 

322. Emergency Preparedness 

Requirements for Medicare and 

Medicaid Participating Providers and 

Suppliers (CMS–3178–F) 

Legal Authority: 42 U.S.C. 1821; 42 

U.S.C. 1861ff (3)(B)(i)(ii); 42 U.S.C. 

1913(c)(1) et al 

Abstract: This rule finalizes 

emergency preparedness requirements 

for Medicare and Medicaid participating 

providers and suppliers to ensure that 

they adequately plan for both natural 

and man-made disasters and coordinate 

with Federal, State, tribal, regional, and 

local emergency preparedness systems. 

This rule ensures providers and 

suppliers are adequately prepared to 

meet the needs of patients, residents, 

clients, and participants during 

disasters and emergency situations. 

Timetable: 

Action Date FR Cite 

NPRM .................. 12/27/13 78 FR 79082 

NPRM Comment 

Period Extended.

02/21/14 79 FR 9872 

NPRM Comment 

Period End.

03/31/14 

Final Action ......... 12/00/16 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Janice Graham, 

Health Insurance Specialist, Department 

of Health and Human Services, Centers 

for Medicare & Medicaid Services, 

Center for Clincial Standards and 

Quality, Mail Stop S3–02–01, 7500 

Security Boulevard, Baltimore, MD 

21244–1850, Phone: 410 786–8020, 

Email: janice.graham@cms.hhs.gov. 

RIN: 0938–AO91 

323. Adoption of Operating Rules for 

HIPAA Transactions (CMS–0036–IFC) 

Legal Authority: Pub. L. 104–191, sec 

1104 

Abstract: Under the Affordable Care 

Act, this interim final rule adopts 

operating rules for HIPAA transactions 

for health care claims or equivalent 

encounter information, enrollment and 

disenrollment of a health plan, health 

plan premium payments, and referral 

certification and authorization. 

Timetable: 

Action Date FR Cite 

Interim Final Rule 11/00/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Geanelle Herring, 

Health Insurance Specialist, Department 

of Health and Human Services, Centers 

for Medicare & Medicaid Services, 

Administrative Simplification Group, 

Office of E–Health Standards and 

Services, Mail Stop S2–26–17, 7500 

Security Boulevard, Baltimore, MD 

21244, Phone: 410 786–4466, Email: 

geanelle.herring@cms.hhs.gov. 

RIN: 0938–AS01 


tkelley on DSK3SPTVN1PROD with PROPOSALS 8
Federal Register / Vol. 79, No. 245 / Monday, December 22, 2014 / Unified Agenda 76729 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES (HHS) 

Centers for Medicare & Medicaid 

Services (CMS) 

Completed Actions 

324. Prospective Payment System for 

Federally Qualified Health Centers; 

Changes to Contracting Policies for 

Rural Health Clinics and CLIA 

Enforcement Actions for Proficiency 

Testing Referral (CMS–1443–FC) 

(Completion of a Section 610 Review) 

Legal Authority: Pub. L. 111–148, sec 

10501 

Abstract: This final rule establishes 

methodology and payment rates for a 

prospective payment system (PPS) for 

Federally qualified health center 

(FQHC) services under Medicare Part B 

beginning on October 1, 2014, in 

compliance with the statutory 

requirement of the Affordable Care Act. 

This rule also establishes a policy which 

would allow rural health clinics (RHCs) 

to contract with nonphysician 

practitioners when statutory 

requirements for employment of nurse 

practitioners and physician assistants 

are met, and makes other technical and 

conforming changes to the RHC and 

FQHC regulations. Finally, this rule 

makes changes to the Clinical 

Laboratory Improvement Amendments 

(CLIA) regulations regarding 

enforcement actions for proficiency 

testing referral. 

Timetable: 

Action Date FR Cite 

NPRM .................. 09/23/13 78 FR 58386 

NPRM Comment 

Period End.

11/18/13 

Final Rule ............ 05/02/14 79 FR 25436 

Comment Period 

End.

07/01/14 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Corinne Axelrod, 

Health Insurance Specialist, Hospital 

and Ambulatory Policy Group, 

Department of Health and Human 

Services, Centers for Medicare & 

Medicaid Services, Mailstop C5–14–03, 

7500 Security Boulevard, Baltimore, MD 

21244, Phone: 410 786–5620, Email: 

corinne.axelrod@cms.hhs.gov. 

RIN: 0938–AR62 

325. Hospital Inpatient Prospective 

Payment System for Acute Care 

Hospitals and the Long-Term Care 

Hospital Prospective Payment System 

and Fiscal Year 2015 Rates (CMS– 

1607–F) (Completion of a Section 610 

Review) 

Legal Authority: sec 1886(d) of the 

Social Security Act 

Abstract: This final rule revises the 

Medicare hospital inpatient and longterm care hospital prospective payment 

systems for operating and capital-related 

costs. This rule implements changes 

arising from our continuing experience 

with these systems. 

Timetable: 

Action Date FR Cite 

NPRM .................. 05/14/14 79 FR 27977 

NPRM Comment 

Period End.

06/30/14 

Final Action ......... 08/22/14 79 FR 49853 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Donald Thompson, 

Deputy Director, Division of Acute Care, 

Department of Health and Human 

Services, Centers for Medicare & 

Medicaid Services, Center for Medicare, 

MS: C4–01–26, 7500 Security 

Boulevard, Baltimore, MD 21244, 

Phone: 410 786–6504, Email: 

donald.thompson@cms.hhs.gov. 

RIN: 0938–AS11 

326. CY 2015 Revisions to Payment 

Policies Under the Physician Fee 

Schedule and Other Revisions to 

Medicare Part B (CMS–1612–FC) 

(Section 610 Review) 

Legal Authority: Social Security Act, 

secs 1102, 1871 and 1848 

Abstract: This final rule addresses 

changes to the physician fee schedule, 

and other Medicare Part B payment 

policies to ensure that our payment 

systems are updated to reflect changes 

in medical practice and the relative 

value of services, as well as changes in 

the statute. 

Timetable: 

Action Date FR Cite 

NPRM .................. 07/11/14 79 FR 40318 

NPRM Comment 

Period End.

09/02/14 

Final Action ......... 11/13/14 79 FR 67548 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Kathy Bryant, 

Director, Division of Practitioner 

Services, Department of Health and 

Human Services, Centers for Medicare & 

Medicaid Services, Mail Stop C4–01–27, 

7500 Security Boulevard, Baltimore, MD 

21244, Phone: 410 786–3448, Email: 

kathy.bryant@cms.hhs.gov. 

RIN: 0938–AS12 

327. CY 2015 End-Stage Renal Disease 

Prospective Payment System, Quality 

Incentive Program, and Durable 

Medical Equipment, Prosthetics, 

Orthotics, and Supplies (CMS–1614–F) 

(Section 610 Review) 

Legal Authority: Social Security Act, 

sec 1834(a)(1)(6); MIPPA, sec 153(b) 

Abstract: This final rule updates and 

makes revisions to the End-Stage Renal 

Disease (ESRD) prospective payment 

system (PPS) for calendar year (CY) 

2015. This rule also sets forth 

requirements for the ESRD quality 

incentive program (QIP), including 

payment years (PYs) 2017 and 2018. 

This rule also makes a technical 

correction to remove outdated terms and 

definitions. In addition, this rule sets 

forth the methodology for adjusting 

Durable Medical Equipment, 

Prosthetics, Orthotics, and Supplies 

(DMEPOS) fee schedule payment 

amounts using information from the 

Medicare DMEPOS Competitive Bidding 

Program (CBP); makes alternative 

payment rules for DME and enteral 

nutrition under the Medicare DMEPOS 

CBP; clarifies the statutory Medicare 

hearing aid coverage exclusion and 

specifies devices not subject to the 

hearing aid exclusion; updates the 

definition of minimal self-adjustment 

regarding what specialized training is 

needed by suppliers to provide custom 

fitting services if they are not certified 

orthotists; clarifies the Change of 

Ownership (CHOW) and provides for an 

exception to the current requirements; 

revises the appeal provisions for 

termination of a contract and 

notification to beneficiaries under the 

Medicare DMEPOS CBP, and adds a 

technical change related to submitting 

bids for infusion drugs under the 

Medicare DMEPOS CBP. 

Timetable: 

Action Date FR Cite 

NPRM .................. 07/11/14 79 FR 40208 

NPRM Comment 

Period End.

09/02/14 

Final Action ......... 11/06/14 79 FR 66120 

Final Action Effective.01/01/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Michelle Cruse, 

Health Insurance Specialist, Department 

of Health and Human Services, Centers 

for Medicare & Medicaid Services, 

Center for Medicare, Mail Stop C5–05– 

27, 7500 Security Boulevard, Baltimore, 


tkelley on DSK3SPTVN1PROD with PROPOSALS 8
76730 Federal Register / Vol. 79, No. 245 / Monday, December 22, 2014 / Unified Agenda 

MD 21244, Phone: 410 786–7540, Email: 

michelle.cruse@cms.hhs.gov. 

RIN: 0938–AS13 

328. CY 2015 Hospital Outpatient 

Prospective Payment System (PPS) 

Policy Changes and Payment Rates, and 

CY 2015 Ambulatory Surgical Center 

Payment System Policy Changes and 

Payment Rates (CMS–1613–FC) (Section 

610 Review) 

Legal Authority: sec 1833 of the Social 

Security Act 

Abstract: This final rule revises the 

Medicare hospital outpatient 

prospective payment system (OPPS) and 

the Medicare ambulatory surgical center 

(ASC) payment system for CY 2015 to 

implement applicable statutory 

requirements and changes arising from 

our continuing experience with these 

systems. In this rule, we describe the 

changes to the amounts and factors used 

to determine the payment rates for 

Medicare services paid under the OPPS 

and those paid under the ASC payment 

system. In addition, this rule updates 

and refines the requirements for the 

Hospital Outpatient Quality Reporting 

(OQR) Program and the ASC Quality 

Reporting (ASCQR) Program. 

Timetable: 

Action Date FR Cite 

NPRM .................. 07/14/14 79 FR 40916 

NPRM Comment 

Period End.

09/02/14 

Final Action ......... 11/13/14 79 FR 66770 

Final Action Effective.01/01/15 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Marjorie Baldo, 

Health Insurance Specialist, Department 

of Health and Human Services, Centers 

for Medicare & Medicaid Services, 

Center for Medicare, MS: C4–03–06, 

7500 Security Boulevard, Baltimore, MD 

21244, Phone: 410 786–4617, Email: 

marjorie.baldo@cms.hhs.gov. 

RIN: 0938–AS15 

329. Extension of Payment Adjustment 

for Low-Volume Hospitals and the 

Medicare-Dependent Hospital Program 

Under the FY 2014 Hospital Inpatient 

Prospective Payment System (CMS– 

1599–IFC2) (Completion of a Section 

610 Review) 

Legal Authority: Pub. L. 113–67, secs 

1105 and 1106 

Abstract: This interim final rule 

implements changes to the payment 

adjustment for low-volume hospitals 

and to the Medicare-dependent hospital 

program under the hospital inpatient 

prospective payment systems for FY 

2014 (through March 31, 2014) in 

accordance with sections 1105 and 

1106, respectively, of the Pathway for 

SGR Reform Act of 2013. 

Timetable: 

Action Date FR Cite 

Interim Final Rule 03/18/14 79 FR 15022 

Interim Final Rule 

Comment Period End.

05/12/14 

Merged With 

0938–AS11.

06/01/14 

Regulatory Flexibility Analysis 

Required: Yes. 

Agency Contact: Michele Hudson, 

Health Insurance Specialist, Department 

of Health and Human Services, Centers 

for Medicare & Medicaid Services, Mail 

Stop C4–10–07, 7500 Security 

Boulevard, Baltimore, MD 21244, 

Phone: 410 786–5490, Email: 

michele.hudson@cms.hhs.gov. 

RIN: 0938–AS18 

[FR Doc. 2014–28964 Filed 12–19–14; 8:45 am] 

BILLING CODE 4150–24–P 


tkelley on DSK3SPTVN1PROD with PROPOSALS 8
Vol. 79 Monday, 

No. 245 December 22, 2014 

Part IX 

Department of Homeland Security 

Semiannual Regulatory Agenda 


tkelley on DSK3SPTVN1PROD with PROPOSALS 9