81 FR 49986 - Change of Address for the Food and Drug Administration Center for Food Safety and Applied Nutrition
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 146 (July 29, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 146 (July 29, 2016)
| Page Range | 49986-49987 | |
| FR Document | 2016-17659 |
[Federal Register Volume 81, Number 146 (Friday, July 29, 2016)] [Notices] [Pages 49986-49987] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-17659] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1773] Change of Address for the Food and Drug Administration Center for Food Safety and Applied Nutrition AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or we) is providing notice that the street address for the Center for Food Safety and Applied Nutrition's (CFSAN's) Harvey W. Wiley Federal Building in College Park, MD has changed. The new street address is 5001 Campus Drive. FOR FURTHER INFORMATION CONTACT: John Reilly, Center for Food Safety and Applied Nutrition (HFS-024), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. SUPPLEMENTARY INFORMATION: The purpose of this notice is to inform the public that the street address for CFSAN's Harvey W. Wiley Federal Building in College Park, MD has changed. The street, formerly known as Paint Branch Parkway, has been renamed ``Campus Drive'' and the street number has been changed to ``5001.'' Thus, the building's street address has changed from 5100 Paint Branch Parkway to 5001 Campus Drive, and our full address is: Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5001 Campus Drive, College Park, MD 20740. Consequently, any mailed correspondence addressed to CFSAN's Harvey W. Wiley Federal Building should use the new street address beginning immediately. [[Page 49987]] Dated: July 21, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-17659 Filed 7-28-16; 8:45 am] BILLING CODE 4164-01-P
![49986 Federal Register / Vol. 81, No. 146 / Friday, July 29, 2016 / Notices
information, including each proposed patient. The Affordable Care Act (OMB control number: 0938–1049);
extension or reinstatement of an existing provision does not amend the statutory Frequency: Yearly; Affected Public:
collection of information, before requirement that a physician must Private sector (Business or other For-
submitting the collection to OMB for certify a patient’s eligibility for profits, Not-For-Profit Institutions);
approval. To comply with this Medicare’s home health benefit, (see Number of Respondents: 10,402; Total
requirement, CMS is publishing this Sections 1814(a)(2)(C) and 1835(a)(2)(A) Annual Responses: 14,155,617; Total
notice. of the Act. Form Number: CMS–10311 Annual Hours: 1,180,578. (For policy
Information Collection (OMB control number: 0938–1083); questions regarding this collection
Frequency: Yearly; Affected Public: contact Martha Kuespert at 410–786–
1. Type of Information Collection Private sector (Business or other For- 4605.)
Request: Extension of a currently profits); Number of Respondents: Dated: July 26, 2016.
approved collection; Title of 345,600; Total Annual Responses:
Information Collection: Medicare Martique Jones,
345,600; Total Annual Hours: 28,800.
Program/Home Health Prospective Director, Regulations Development Group,
(For policy questions regarding this Office of Strategic Operations and Regulatory
Payment System Rate Update for collection contact Hillary Loeffler at
Calendar Year 2010: Physician Narrative Affairs.
410–786–0456.) [FR Doc. 2016–17987 Filed 7–28–16; 8:45 am]
Requirement and Supporting
2. Type of Information Collection
Regulation; Use: Section (o) of the Act BILLING CODE 4120–01–P
Request: Extension of a currently
(42 U.S.C. 1395 x) specifies certain
requirements that a home health agency approved collection; Title of
must meet to participate in the Medicare Information Collection: Documentation DEPARTMENT OF HEALTH AND
program. To qualify for Medicare Requirements Concerning Emergency HUMAN SERVICES
coverage of home health services a and Nonemergency Ambulance
Transports Described in the Beneficiary Food and Drug Administration
Medicare beneficiary must meet each of
the following requirements as stipulated Signature Regulations in 42 CFR
in § 409.42: Be confined to the home or 424.36(b); Use: The statutory authority [Docket No. FDA–2016–N–1773]
an institution that is not a hospital, requiring a beneficiary’s signature on a
SNF, or nursing facility as defined in claim submitted by a provider is located Change of Address for the Food and
sections 1861(e)(1), 1819(a)(1) or 1919 of in section 1835(a) and in 1814(a) of the Drug Administration Center for Food
Act; be under the care of a physician as Social Security Act (the Act), for Part B Safety and Applied Nutrition
described in § 409.42(b); be under a plan and Part A services, respectively. The
authority requiring a beneficiary’s AGENCY: Food and Drug Administration,
of care that meets the requirements HHS.
specified in § 409.43; the care must be signature for supplier claims is implicit
in sections 1842(b)(3)(B)(ii) and in ACTION: Notice.
furnished by or under arrangements
made by a participating HHA, and the 1848(g)(4) of the Act. Federal
SUMMARY: The Food and Drug
beneficiary must be in need of skilled regulations at 42 CFR 424.32(a)(3) state
that all claims must be signed by the Administration (FDA or we) is
services as described in § 409.42(c). providing notice that the street address
Subsection 409.42(c) of our regulations beneficiary or on behalf of the
beneficiary (in accordance with 424.36). for the Center for Food Safety and
requires that the beneficiary need at Applied Nutrition’s (CFSAN’s) Harvey
least one of the following services as Section 424.36(a) states that the
beneficiary’s signature is required on a W. Wiley Federal Building in College
certified by a physician in accordance Park, MD has changed. The new street
with § 424.22: Intermittent skilled claim unless the beneficiary has died or
the provisions of 424.36(b), (c), or (d) address is 5001 Campus Drive.
nursing services and the need for skilled
apply. We believe that for emergency FOR FURTHER INFORMATION CONTACT: John
services which meet the criteria in
§ 409.32; Physical therapy which meets and nonemergency ambulance transport Reilly, Center for Food Safety and
the requirements of § 409.44(c), Speech- services, where the beneficiary is Applied Nutrition (HFS–024), Food and
language pathology which meets the physically or mentally incapable of Drug Administration, 5001 Campus Dr.,
requirements of § 409.44(c); or have a signing the claim (and the beneficiary’s College Park, MD 20740.
continuing need for occupational authorized representative is unavailable SUPPLEMENTARY INFORMATION: The
therapy that meets the requirements of or unwilling to sign the claim), that it purpose of this notice is to inform the
§ 409.44(c), subject to the limitations is impractical and infeasible to require public that the street address for
described in § 409.42(c)(4). On March an ambulance provider or supplier to CFSAN’s Harvey W. Wiley Federal
23, 2010, the Affordable Care Act of later locate the beneficiary or the person Building in College Park, MD has
2010 (Pub. L., 111–148) was enacted. authorized to sign on behalf of the changed. The street, formerly known as
Section 6407(a) (amended by section beneficiary, before submitting the claim Paint Branch Parkway, has been
10605) of the Affordable Care Act to Medicare for payment. Therefore, we renamed ‘‘Campus Drive’’ and the street
amends the requirements for physician created an exception to the beneficiary number has been changed to ‘‘5001.’’
certification of home health services signature requirement with respect to Thus, the building’s street address has
contained in Sections 1814(a)(2)(C) and emergency and nonemergency changed from 5100 Paint Branch
1835(a)(2)(A) by requiring that, prior to ambulance transport services, where the Parkway to 5001 Campus Drive, and our
certifying a patient as eligible for beneficiary is physically or mentally full address is: Center for Food Safety
Medicare’s home health benefit, the incapable of signing the claim, and if and Applied Nutrition, Food and Drug
ebenthall on DSK5MVXVN1PROD with NOTICES
physician must document that the certain documentation requirements are Administration, 5001 Campus Drive,
physician himself or herself or a met. Thus, we added subsection (6) to College Park, MD 20740.
permitted non-physician practitioner paragraph (b) of 42 CFR 424.36. The Consequently, any mailed
has had a face-to-face encounter information required in this ICR is correspondence addressed to CFSAN’s
(including through the use of tele-health needed to help ensure that services were Harvey W. Wiley Federal Building
services, subject to the requirements in in fact rendered and were rendered as should use the new street address
section 1834(m) of the Act)’’, with the billed. Form Number: CMS–10242 beginning immediately.
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![Federal Register / Vol. 81, No. 146 / Friday, July 29, 2016 / Notices 49987
Dated: July 21, 2016. how the fees for FY 2017 were The FD&C Act specifies the base fee
Leslie Kux, determined, the payment procedures for establishment registration for each
Associate Commissioner for Policy. you should follow, and how you may year from FY 2013 through FY 2017; the
[FR Doc. 2016–17659 Filed 7–28–16; 8:45 am] qualify for reduced small business fees. base fee for an establishment
BILLING CODE 4164–01–P FOR FURTHER INFORMATION CONTACT: registration in FY 2017 is $3,872. There
For information on Medical Device is no reduction in the registration fee for
User Fees: Visit FDA’s Web site at small businesses. Each establishment
DEPARTMENT OF HEALTH AND http://www.fda.gov/ForIndustry/ that is registered (or is required to
HUMAN SERVICES UserFees/MedicalDeviceUserFee/ register) with the Secretary under
ucm20081521.htm. section 510 of the FD&C Act (21 U.S.C.
Food and Drug Administration For questions relating to this notice: 360) because such establishment is
[Docket No. FDA–2016–N–0007] Maurille Beheton, Office of Financial engaged in the manufacture,
Management, Food and Drug preparation, propagation, compounding,
Medical Device User Fee Rates for Administration, 8455 Colesville Rd. or processing of a device is required to
Fiscal Year 2017 (COLE–14202C), Silver Spring, MD pay the annual fee for establishment
20993–0002, 301–796–4689. registration.
AGENCY: Food and Drug Administration,
HHS. SUPPLEMENTARY INFORMATION: II. Revenue Amount for FY 2017
ACTION: Notice. I. Background
The total revenue amount for FY 2017
SUMMARY: The Food and Drug Section 738 of the FD&C Act (21 is $130,184,348, as set forth in the
Administration (FDA) is announcing the U.S.C. 379j) establishes fees for certain statute prior to the inflation adjustment
fee rates and payment procedures for medical device applications, and offset of excess collections (see 21
medical device user fees for fiscal year submissions, supplements, and notices U.S.C. 379j(b)(3)). MDUFA directs FDA
(FY) 2017. The Federal Food, Drug, and (for simplicity, this document refers to to use the yearly total revenue amount
Cosmetic Act (the FD&C Act), as these collectively as ‘‘submissions’’ or as a starting point to set the standard fee
amended by the Medical Device User ‘‘applications’’); for periodic reporting rates for each fee type. The fee
Fee Amendments of 2012 (MDUFA III), on class III devices; and for the calculations for FY 2017 are described
authorizes FDA to collect user fees for registration of certain establishments. in this document.
certain medical device submissions and Under statutorily defined conditions, a
qualified applicant may receive a fee A. Inflation Adjustment
annual fees both for certain periodic
reports and for establishments subject to waiver or may pay a lower small MDUFA specifies that the
registration. This notice establishes the business fee (see 21 U.S.C. 379j(d) and $130,184,348 is to be adjusted for
fee rates for FY 2017, which apply from (e)). Additionally, the Secretary of inflation increases for FY 2017 using
October 1, 2016, through September 30, Health and Human Services (the two separate adjustments—one for
2017. To avoid delay in the review of Secretary) may, at the Secretary’s sole payroll costs and one for non-pay cost
your application, you should pay the discretion, grant a fee waiver or (see 21 U.S.C. 379j(c)(2)). The base
application fee before or at the time you reduction if the Secretary finds that inflation adjustment for FY 2017 is the
submit your application to FDA. The fee such waiver or reduction is in the sum of one plus these two separate
you must pay is the fee that is in effect interest of public health (see 21 U.S.C. adjustments, and is compounded as
on the later of the date that your 379j(f)). specified (see 21 U.S.C. 379j(c)(2)(C)(1)
application is received by FDA or the Under the FD&C Act, the fee rate for and 379j(c)(2)(B)(ii)).
date your fee payment is recognized by each type of submission is set at a
the U.S. Treasury. If you want to pay a specified percentage of the standard fee The component of the inflation
reduced small business fee, you must for a premarket application (a premarket adjustment for payroll costs is the
qualify as a small business before application is a premarket approval average annual percent change in the
making your submission to FDA; if you application (PMA), a product cost of all personnel compensation and
do not qualify as a small business before development protocol (PDP), or a benefits (PC&B) paid per full-time
making your submission to FDA, you biologics license application (BLA)). equivalent position (FTE) at FDA for the
will have to pay the higher standard fee. The FD&C Act specifies the base fee for first 3 of the 4 preceding FYs,
Please note that the establishment a premarket application for each year multiplied by 0.60, or 60 percent (see 21
registration fee is not eligible for a from FY 2013 through FY 2017; the base U.S.C. 379j(c)(2)(C)).
reduced small business fee. As a result, fee for a premarket application received Table 1 summarizes the actual cost
if the establishment registration fee is by FDA during FY 2017 is $268,443. and FTE data for the specified FYs, and
the only medical device user fee that From this starting point, this document provides the percent change from the
you will pay in FY 2017, you should not establishes FY 2017 fee rates for other previous FY and the average percent
submit a FY 2017 Small Business types of submissions, and for periodic change over the first 3 of the 4 FYs
Qualification and Certification request. reporting, by applying criteria specified preceding FY 2017. The 3-year average
This document provides information on in the FD&C Act. is 1.8759 percent (rounded).
TABLE 1—FDA PC&BS EACH YEAR AND PERCENT CHANGE
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3-Year
Fiscal Year 2013 2014 2015 average
Total PC&B .................................................................................... $1,927,703,000 $2,054,937,000 $2,232,304,000 ........................
Total FTE ....................................................................................... 13,974 14,555 15,484 ........................
PC&B per FTE ............................................................................... $137,949 $141,184 $144,168 ........................
Percent change from previous year .............................................. 1.1690% 2.3451% 2.1136% 1.8759%
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Document Created: 2018-02-08 07:52:08
Document Modified: 2018-02-08 07:52:08
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Contact | John Reilly, Center for Food Safety and Applied Nutrition (HFS-024), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. | |
| FR Citation | 81 FR 49986 |
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