Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices 73083 

Table 2 of this document provides a 

one-time recordkeeping burden estimate 

for the information to be submitted in 

accordance with the draft guidance. As 

described in the proceeding paragraphs, 

based on FDA’s experience and industry 

information, FDA anticipates that 150 

respondents, mainly from large volume 

transfusion services, will implement the 

recommendations set forth in section 

IX.A.2. Thus, based on FDA data and 

industry recordkeeping information, 

FDA estimates that the total estimated 

one-time recordkeeping burden is 2,400 

hours. 

This draft guidance also refers to 

previously approved collections of 

information found in FDA regulations. 

The collections of information in 21 

CFR 601.12 and 610.60 have been 

approved under OMB control number 

0910–0338; the collections of 

information in 21 CFR 606.65, 606.100, 

606.120, 606.121, 606.122, and 606.140 

have been approved under OMB control 

number 0910–0116; and the collections 

of information in 21 CFR 607.3, 607.7 

and 607.65 have been approved under 

OMB control number 0910–0052. 

III. Comments 

The draft guidance is being 

distributed for comment purposes only 

and is not intended for implementation 

at this time. Interested persons may 

submit either electronic comments 

regarding this document to http:// 

www.regulations.gov or written 

comments to the Division of Dockets 

Management (see ADDRESSES). It is only 

necessary to send one set of comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

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

will be posted to the docket at http:// 

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the draft guidance at either 

http://www.fda.gov/BiologicsBlood

Vaccines/GuidanceCompliance

RegulatoryInformation/Guidances/ 

default.htm or http:// 

www.regulations.gov. 

Dated: December 4, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28809 Filed 12–8–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–2083] 

Draft Guidance for Industry on Drug 

Supply Chain Security Act 

Implementation: Annual Reporting by 

Prescription Drug Wholesale 

Distributors and Third-Party Logistics 

Providers; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a draft guidance for 

industry entitled ‘‘Drug Supply Chain 

Security Act Implementation: Annual 

Reporting by Prescription Drug 

Wholesale Distributors and Third-Party 

Logistics Providers.’’ This draft 

guidance addresses new provisions in 

the Federal Food, Drug, and Cosmetic 

Act (the FD&C Act), as amended by the 

Drug Supply Chain Security Act 

(DSCSA). The draft guidance describes 

FDA’s expectations for prescription 

drug wholesale distributors (wholesale 

distributors) and third-party logistics 

providers (3PLs) about reporting to FDA 

under the DSCSA. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by February 9, 

2015. Submit either electronic or 

written comments concerning the 

collection of information proposed in 

the draft guidance by February 9, 2015. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance to the 

Division of Drug Information, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10001 New 

Hampshire Ave., Hillandale Building, 

4th Floor, 4147, Silver Spring, MD 

20993; or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

3128, Silver Spring, MD 20993. Send 

one self-addressed adhesive label to 

assist that office in processing your 

requests. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the draft guidance document. 

Submit electronic comments on the 

draft 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: 

Suzanne Barone, Office of Compliance, 

Center for Drug Evaluation and 

Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Silver Spring, MD 20993–0002, 

301–796–3130, wdd3plrequirements@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a draft guidance for industry entitled 

‘‘Drug Supply Chain Security Act 

Implementation: Annual Reporting by 

Prescription Drug Wholesale 

Distributors and Third-Party Logistics 

Providers.’’ This guidance is being 

issued to facilitate implementation of 

new reporting provisions under the 

DSCSA. On November 27, 2013, the 

DSCSA (Title II of Pub. L. 113–54) was 

signed into law. The DSCSA outlines 

new requirements for the licensing of 

prescription drug wholesale distributors 

and 3PLs. 

Section 204 of the DSCSA amends 

section 503(e) of the FD&C Act (21 

U.S.C. 353(e)) and outlines requirements 

for reporting by wholesale distributors. 

Section 503(e)(2)(A) of the FD&C Act (as 

amended) requires wholesale 

distributors to report annually, 

beginning on January 1, 2015. 

Information to be reported includes 

State licensure information and contact 

information for each facility. Wholesale 

distributors are also to report to FDA 

any significant disciplinary actions 

taken by the State or Federal 

Government, such as revocation or 

suspension of a license. Section 204 of 

the DSCSA also amends section 

503(e)(2)(B) of the FD&C Act and 

requires FDA to make information about 

wholesale distributors’ licensure 

available to the public on FDA’s Web 

site. Updates to the public information 

are to be made on a schedule to be 

determined by FDA. 

Section 205 of the DSCSA adds 

section 584 to the FD&C Act. Section 

584 sets forth requirements for licensure 

and reporting by 3PLs. Under section 

584 of the FD&C Act (as amended) (21 

U.S.C. 360eee–3), 3PLs are required to 

report annually to FDA, beginning on 

November 27, 2014 (1 year after the date 

of enactment of the DSCSA). Thirdparty logistic providers are required to 

report State licensure information, name 

and address for each facility, and all 

trade names under which each facility 

conducts business. 


rljohnson on DSK3VPTVN1PROD with NOTICES
73084 Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices 

1Title XXXIII chapter 499 Florida statues 

(http://www.flsenate.gov/laws/statutes/2011/

0499.01) 

2 ‘‘Third-Party Logistics Providers Licensure 

Requirements’’ Pat O’Connor, IWLA, presented at 

DQSA: Meeting Supply Responsibilities, Food and 

Drug Law Institute, February 20, 2014, Washington, 

DC. 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

about information that should be 

submitted to FDA, the timing of the 

submissions, a preferred format for the 

submissions, and a preferred method for 

reporting to FDA by wholesale 

distributors and 3PLs. 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 draft guidance contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 (44 

U.S.C. 3501–3520). The title, 

description, and respondent description 

of the information collection are given 

under this section with an estimate of 

the reporting burdens. Included in the 

estimate is the time for reviewing 

instructions, searching existing data 

sources, and completing and reviewing 

the collection of information annually. 

We invite comments on these topics: 

(1) Whether the proposed collection of 

information is necessary for the proper 

performance of FDA’s functions, 

including whether the information will 

have practical utility; (2) the accuracy of 

FDA’s estimate of the burden of the 

proposed collection of information, 

including the validity of the 

methodology and assumptions used; (3) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (4) ways to minimize the 

burden of the collection of information 

on respondents, including through the 

use of automated collection techniques, 

when appropriate, and other forms of 

information technology. 

Title: Drug Supply Chain Security Act 

Implementation: Annual Reporting by 

Prescription Drug Wholesale 

Distributors and Third-Party Logistics 

Providers. 

Description: On November 27, 2013, 

the DSCSA was signed into law. Section 

503(e)(2) of the FD&C Act requires 

licensed wholesale distributors to report 

annually, beginning January 1, 2015. 

Information to be reported includes 

each State by which the wholesale 

distributor is licensed and the 

appropriate identification number of 

each license; and the name, address, 

and contact information of each facility 

at which, and all trade names under 

which, the wholesale distributor 

conducts business. Wholesale 

distributors are also required to report 

any significant disciplinary actions, 

such as revocation or suspension of a 

license. In addition, FDA is requesting 

the voluntary submission of a unique 

facility identifier, the expiration date of 

each State license, and documents 

associated with the disciplinary action, 

such as consent decree, final State 

Board ruling, etc. 

The DSCSA also outlines reporting 

requirements for 3PLs. Under section 

584 of the FD&C Act (as amended), 3PLs 

are required to report to FDA annually, 

beginning 1 year after the enactment of 

the DSCSA (November 27, 2014), the 

State by which a facility is licensed and 

the appropriate identification number 

and the name, address, and all trade 

names under which the facility 

conducts business. Because certain 

additional information will be useful to 

FDA in its enforcement of the Act, FDA 

is also requesting that 3PLs voluntarily 

provide the same information as 

wholesale distributors. The ultimate 

goal is for the public database to serve 

as a single repository of licensing and 

facility information for wholesale drug 

distributors and 3PLs conducting 

business in the United States. 

A. Estimates of Reporters 

The exact number of wholesale 

distributors required to report to FDA is 

unknown because the license status 

information for each wholesale 

distributor facility is currently 

maintained by each State. The DSCSA 

excludes several categories of 

businesses from the definition of 

wholesale distribution that may have 

been licensed by States as wholesale 

distributors before the DSCSA was 

enacted. FDA estimates that about 5,000 

wholesale distributor facilities will 

report to FDA. This number is based on 

estimates of active wholesale facilities 

that distribute pharmaceuticals which 

include drugs, proprietaries, and 

sundries according to Dun & Bradstreet. 

This number may be an overestimation 

since this category may contain 

distributors that do not distribute 

prescription drugs. 

The exact number of prescription 

drug 3PLs in the United States is also 

unknown because prior to the 

enactment of DSCSA, most states 

licensed 3PLs as wholesale distributors 

with the exception of Florida.1 The 

International Warehouse Logistics 

Association (IWLA) has stated that the 

best estimate of the number of 3PLs 

involved with prescription drugs is 

indicated by the number licensed by 

Florida.2 Therefore, FDA is using the 

number of 3PLs licensed by Florida as 

an estimate of the number of 3PLs in the 

United States. The Florida Drugs, 

Devices, and Cosmetics Licensee Files 

database (on July 16, 2014) contains 136 

warehouses licensed as 3PLs, located in 

28 different states. The location of each 

facility was verified by license number. 

B. Initial Report 

FDA estimates that the time and effort 

for wholesale distributors and 3PLs to 

make the initial report to FDA will be 

greater than reporting for subsequent 

reports made thereafter because of the 

amount of information submitted will 

include all State licensure information. 

Subsequent reports submitted to FDA 

will only include information that needs 

to be updated or added. 

Each wholesale distributor must 

report the following information for 

each facility: 

• Name, address, and contact 

information (including email address 

and telephone number), 

• each State license and license 

identifying number, 

• all trade names that the facility 

conducts business as (dba), and 

• significant disciplinary actions. 

In addition, FDA is requesting that 

wholesale distributors report the 

following information: 

• Expiration dates for each State 

license, 

• unique facility identifier (D–U–N–S 

number), and 

• documents associated with the 

disciplinary action, such as a consent 

decree, final State Board ruling, etc. 

3PLs should submit the same 

information as wholesale distributors, 

including significant disciplinary 

actions. Some of this information is 

required under the DSCSA to be 

submitted by 3PLs including name, 

address, State license, and State license 

identifying number; the other categories 

are voluntary for 3PLs. 

The information listed above is 

readily available to the facilities, 

including the unique facility identifier. 

FDA currently prefers D–U–N–S 

number as the unique facility 

identification for the location of each 

facility. For a facility that has not been 

assigned a number, a number may be 

obtained for no cost directly from Dun 

& Bradstreet (http://www.dnb.com). 

Each facility may have differing 


rljohnson on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices 73085 

numbers of State license information to 

input and may or may not have any 

significant disciplinary actions for each 

State. FDA is providing a Web portal for 

the efficient entry and submission of 

this information. Companies using this 

portal will not have to convert the 

information to report into an extensible 

markup language (XML) file in the 

Structured Product Label (SPL) format 

and submit it separately through the 

FDA gateway. No special computer 

program or expertise is required if the 

Web portal is used. We estimate that it 

will take wholesale distributors and 

3PLs on average about 0.5 hours per 

facility to collect and input this 

information for the initial reporting, for 

a total burden for the first year of 2,568 

hours. Refer to table 1. 

C. Subsequent Annual Reports 

FDA will maintain the information 

submitted previously for each facility’s 

initial report. This information will be 

readily accessible through the FDAsupplied Web portal. This eliminates 

the need for re-entry of all of the 

information each year. We estimate that 

it will take 0.25 hours each subsequent 

year to review and update information 

such as, but not limited to, a license 

expiration date following renewal or a 

resolution of a disciplinary action. The 

total annual burden for wholesale 

distributors and 3PLs is 1,284 hours 

(table 2). 

D. Significant Disciplinary Action 

Reports 

Wholesale distributors are required 

and 3PLs are requested to report 

significant disciplinary actions. The 

number of distributors and 3PLs that 

will have significant disciplinary action 

taken against them is unknown. 

Disciplinary actions are currently 

handled by the individual States’ 

regulatory authorities. FDA does not 

believe that the number of significant 

disciplinary actions that would limit the 

ability of a wholesale distributor or 3PL 

to warehouse and/or distribute 

prescription drugs would be greater 

than 1 percent of the total number of 

facilities that report on an annual basis. 

This would be equivalent to 

approximately 50 wholesale distributors 

and 2 3PLs. Significant disciplinary 

action information requested should be 

readily available to each wholesale 

distributor and 3PL involved in the 

action. FDA estimates that it will take 

0.5 hours for the wholesale distributor 

or 3PL to access the system, input 

information, and upload documents (if 

available) using the Web portal. FDA 

estimates that the total annual burden of 

reporting significant disciplinary action 

is 26 hours (table 3). 

E. Other Voluntary Reports 

FDA is also requesting that a 

wholesale distributor or 3PL notify FDA 

within 30 days if a facility goes out of 

business or voluntarily withdraws a 

State or Federal license. FDA estimates 

that this reporting type will occur 

infrequently; involving five wholesale 

distributor facilities and one 3PL facility 

per year. We estimate that it will take 

0.25 hours to update the company or 

license status. FDA estimates that the 

total annual burden of reporting these 

voluntary reports is 1.5 hours (table 4). 

Description of Respondents: 

Respondents are prescription drug 

wholesale distributors and third-party 

logistics providers and might include 

small businesses in these categories. 

TABLE 1—INITIAL REPORT BURDEN 1 2

Initial reporting to FDA Number of 

respondents 

Number of 

responses per 

respondent 

Total initial 

responses 

Average 

burden per 

response 

Total hours 

Wholesale Distributors .......................................................... 5,000 1 5,000 0.5 hour (30 

minutes).

2,500 

3PLs ...................................................................................... 136 1 136 0.5 hour (30 

minutes).

68 

Total ............................................................................... ........................ ........................ ........................ ...................... 2568 

1Any fraction is rounded up to a whole number. 

2There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 2—SUBSEQUENT REPORTS BURDEN 1

Annual reporting to FDA Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

Total hours 

Wholesale distributors ........................................................... 5,000 1 5,000 0.25 hour (15 

minutes).

1,250 

3PLs ...................................................................................... 136 1 136 0.25 hour (15 

minutes).

34 

Total ............................................................................... ........................ ........................ ........................ ...................... 1,284 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 3—SIGNIFICANT DISCIPLINARY ACTION REPORT BURDEN 1

Significant disciplinary actions Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

Total hours 

Wholesale distributors ........................................................... 50 1 50 0.5 hour (30 

minutes).

25 

3PLs ...................................................................................... 2 1 2 0.5 hour (30 

minutes).

1 


rljohnson on DSK3VPTVN1PROD with NOTICES
73086 Federal Register / Vol. 79, No. 236 / Tuesday, December 9, 2014 / Notices 

TABLE 3—SIGNIFICANT DISCIPLINARY ACTION REPORT BURDEN 1—Continued 

Significant disciplinary actions Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

Total hours 

Total ............................................................................... ........................ ........................ ........................ ...................... 26 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

TABLE 4—OTHER VOLUNTARY REPORTS BURDEN 1

Other voluntary reports Number of 

respondents 

Number of 

responses per 

respondent 

Total 

responses 

Average 

burden per 

response 

Total hours 

Wholesale distributors ........................................................... 5 1 5 0.25 hour (15 

minutes).

1.25 

3PLs ...................................................................................... 1 1 1 0.25 hour (15 

minutes).

0.25 

Total ............................................................................... ........................ ........................ ........................ ...................... 1.50 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

F. Capital Costs 

There are no capital costs associated 

with this collection and reporting of 

information if the FDA-provided Web 

portal is used for reporting. 

III. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

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

will be posted to the docket at http://

www.regulations.gov. 

IV. Electronic Access 

Persons with access to the Internet 

may obtain the document at http://

www.fda.gov/Drugs/Guidance

ComplianceRegulatoryInformation/

Guidances/default.htm, http://

www.fda.gov/BiologicsBloodVaccines/

GuidanceComplianceRegulatory

Information/Guidances/default.htm, or 

http://www.regulations.gov. 

Dated: December 3, 2014. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2014–28711 Filed 12–8–14; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–N–0001] 

Endocrinologic and Metabolic Drugs 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Endocrinologic 

and Metabolic Drugs Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on January 12, 2015, from 8 a.m. 

to 5 p.m. 

Location: College Park Marriott Hotel 

and Conference Center, Potomac 

Ballroom, 3501 University Blvd. East, 

Hyattsville, MD 20783. The conference 

center’s telephone number is 301–985– 

7300. 

Contact Person: Stephanie L. 

Begansky, Center for Drug Evaluation 

and Research, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 31, Rm. 2417, Silver Spring, 

MD 20993–0002, 301–796–9001, FAX: 

301–847–8533, email: EMDAC@

fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s Web site at http://

www.fda.gov/AdvisoryCommittees/

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

Agenda: The committee will discuss 

the safety and efficacy of new drug 

application (NDA) 022517, proposed 

trade name NOCDURNA (established 

name: desmopressin), orally 

disintegrating sublingual tablets 

submitted by Ferring Pharmaceuticals, 

Inc. The proposed indication is 

treatment of nocturia due to nocturnal 

polyuria in adults who awaken two or 

more times each night to void. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

available at http://www.fda.gov/

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before December 26, 2014. 


rljohnson on DSK3VPTVN1PROD with NOTICES