Federal Register / Vol. 79, No. 26 / Friday, February 7, 2014 / Notices 7463 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

[Document Identifiers: CMS–R–53] 

Agency Information Collection 

Activities: Submission for OMB Review 

ACTION: Notice; withdrawal. 

SUMMARY: The Centers for Medicare and 

Medicaid Services published a 

document in the Federal Register on 

January 27, 2014, concerning the 

submission of an information collection 

request for OMB review and a request 

for public comments. The document 

was published in error. 

Withdrawal 

In the Federal Register of January 27, 

2014, in FR Doc. 2014–01465, on page 

4345 in the second and third columns 

and on page 4346 in the first column, a 

30-day notice for an information 

collection request published. We are 

withdrawing the notice and thereby the 

information collection request (ICR). At 

this time, we are not submitting the ICR 

to OMB and we are not requesting 

public comments. The collection is 

entitled, ‘‘Imposition of Cost Sharing 

Charges Under Medicaid and 

Supporting Regulations.’’ 

Dated: February 4, 2014. 

Martique Jones, 

Deputy Director, Regulations Development 

Group, Office of Strategic Operations and 

Regulatory Affairs. 

[FR Doc. 2014–02660 Filed 2–6–14; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–D–0077 (formerly 

2007D–0213)] 

Guidance for Industry; Providing 

Regulatory Submissions in Electronic 

Format—Receipt Date; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

entitled ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Receipt Date.’’ This guidance describes 

how FDA will assign receipt dates to 

certain submissions provided in 

electronic format to the Center for Drug 

Evaluation and Research (CDER) and the 

Center for Biologics Evaluation and 

Research (CBER). This document 

finalizes the guidance of the same name, 

which was issued in June 2007. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the documents to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 2201, 

Silver Spring, MD 20993–0002 or the 

Office of Communication, Outreach and 

Development (HFM–40), Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 1401 

Rockville Pike, Suite 200N, Rockville, 

MD 20852–1448. Send one selfaddressed adhesive label to assist that 

office in processing your requests. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the documents. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments to the 

Division of Dockets Management (HFA– 

305), Food and Drug Administration, 

5630 Fishers Lane, Rm. 1061, Rockville, 

MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Edward Hallissey, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 1139, 

Silver Spring, MD 20993, 301–796– 

0420; or Stephen Ripley, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 5515 

Security Lane, Rm. 5130, Rockville, MD 

20852, 301–827–6210. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

guidance for industry entitled 

‘‘Providing Regulatory Submissions in 

Electronic Format—Receipt Date.’’ This 

guidance describes how FDA will assign 

receipt dates to certain submissions 

provided in electronic format or in 

physical media to CDER and CBER. 

When CDER or CBER receives a 

submission, the receipt date may be 

used to determine important regulatory 

milestones, such as FDA’s 30-day safety 

review cycle for an investigative new 

drug (IND) application. The guidance 

provides clarity regarding when items 

submitted electronically are deemed 

received by FDA for purposes of such 

milestones. Prior to issuance of this 

final guidance, certain submissions 

received through the electronic 

submission gateway (ESG) after 4:30 

p.m. were deemed to be received on the 

following business day. With this final 

guidance, we are generally eliminating 

this 4:30 p.m. cut-off for submissions 

received through the ESG Monday 

through Friday. However, certain 

submissions received through the ESG 

on a weekend, Federal holiday, or on a 

day when the FDA office that will 

review the submission is otherwise not 

open for business, will be assigned a 

receipt date corresponding to the next 

business day. 

Occasionally, submissions in 

electronic format have technical 

deficiencies that prevent FDA from 

opening, processing, or archiving the 

submission. The guidance explains that 

FDA considers a technically deficient 

electronic submission to be not received 

(i.e., not present at the Agency and not 

under review) until all technical 

deficiencies are resolved. 

On June 5, 2007 (72 FR 31079), FDA 

announced the availability of the draft 

version of this guidance. The public 

comment period closed on August 6, 

2007. Several comments were received 

from the public, all of which the Agency 

considered carefully as it finalized the 

guidance and made appropriate 

changes. Those changes clarified the 

draft guidance and updated the 

document to reflect legislative 

provisions adopted since the draft was 

issued. More specifically, the final 

guidance generally eliminates the 4:30 

p.m. cut-off for submissions received 

through the ESG Monday through 

Friday. It also provides guidance on 

FDA’s interpretation of a provision in 

the Generic Drug User Fee Amendments 

of 2012 (GDUFA) concerning the date of 

submission for Type II drug master files, 

Abbreviated New Drug Applications 

(ANDAs), and amendments and 

supplements to ANDAs. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the Agency’s 

current thinking on determining the 

receipt date for certain submissions in 

electronic format or in physical media. 

It does not create or confer any rights for 

or on any person and does not operate 

to bind FDA or the public. An 

alternative approach may be used if 

such approach satisfies the 

requirements of the applicable statutes 

and regulations. 

II. Paperwork Reduction Act of 1995 

The guidance refers to collections of 

information that are subject to review by 

the Office of Management and Budget 

(OMB) under the Paperwork Reduction 

Act of 1995, 44 U.S.C. 3501–3520. The 

guidance pertains to sponsors and 

applicants making regulatory 

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