15214 Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices 

delivery. The Patient Safety Rule 

authorizes AHRQ, on behalf of the 

Secretary of HHS, to list as a PSO an 

entity that attests that it meets the 

statutory and regulatory requirements 

for listing. A PSO can be ‘‘delisted’’ by 

the Secretary if it is found to no longer 

meet the requirements of the Patient 

Safety Act and Patient Safety Rule, 

when a PSO chooses to voluntarily 

relinquish its status as a PSO for any 

reason, or when a PSO’s listing expires. 

AHRQ has accepted a notification of 

voluntary relinquishment from PSO 

Services Group of its status as a PSO, 

and has delisted the PSO accordingly. 

DATES: The directories for both listed 

and delisted PSOs are ongoing and 

reviewed weekly by AHRQ. The 

delisting was effective at 12:00 Midnight 

ET (2400) on January 5, 2015. 

ADDRESSES: Both directories can be 

accessed electronically at the following 

HHS Web site: http://

www.pso.AHRQ.gov/index.html. 

FOR FURTHER INFORMATION CONTACT: 

Eileen Hogan, Center for Quality 

Improvement and Patient Safety, AHRQ, 

540 Gaither Road, Rockville, MD 20850; 

Telephone (toll free): (866) 403–3697; 

Telephone (local): (301) 427–1111; TTY 

(toll free): (866) 438–7231; TTY (local): 

(301) 427–1130; Email: PSO@

AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

The Patient Safety Act authorizes the 

listing of PSOs, which are entities or 

component organizations whose 

mission and primary activity are to 

conduct activities to improve patient 

safety and the quality of health care 

delivery. 

HHS issued the Patient Safety Rule to 

implement the Patient Safety Act. 

AHRQ administers the provisions of the 

Patient Safety Act and Patient Safety 

Rule relating to the listing and operation 

of PSOs. The Patient Safety Rule 

authorizes AHRQ to list as a PSO an 

entity that attests that it meets the 

statutory and regulatory requirements 

for listing. A PSO can be ‘‘delisted’’ if 

it is found to no longer meet the 

requirements of the Patient Safety Act 

and Patient Safety Rule, when a PSO 

chooses to voluntarily relinquish its 

status as a PSO for any reason, or when 

a PSO’s listing expires. Section 3.108(d) 

of the Patient Safety Rule requires 

AHRQ to provide public notice when it 

removes an organization from the list of 

federally approved PSOs. 

AHRQ has accepted a notification 

from PSO Services Group, PSO number 

P0028, to voluntarily relinquish its 

status as a PSO. Accordingly, PSO 

Services Group was delisted effective at 

12:00 Midnight ET (2400) on January 5, 

2015. 

PSO Services Group has patient safety 

work product (PSWP) in its possession. 

The PSO will meet the requirements of 

section 3.108(c)(2)(i) of the Patient 

Safety Rule regarding notification to 

providers that have reported to the PSO. 

In addition, according to sections 

3.108(c)(2)(ii) and 3.108(b)(3) of the 

Patient Safety Rule regarding 

disposition of PSWP, the PSO has 90 

days from the effective date of delisting 

and revocation to complete the 

disposition of PSWP that is currently in 

the PSO’s possession. 

More information on PSOs can be 

obtained through AHRQ’s PSO Web site 

at http://www.pso.AHRQ.gov/

index.html. 

Dated: March 17, 2015. 

Sharon B. Arnold, 

Deputy Director, AHRQ. 

[FR Doc. 2015–06455 Filed 3–20–15; 8:45 am] 

BILLING CODE 4160–90–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0742] 

Agency Information Collection 

Activities; Proposed Collection; 

Comment Request; Registration of 

Producers of Drugs and Listing of 

Drugs in Commercial Distribution 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing an 

opportunity for public comment on the 

proposed collection of certain 

information by the Agency. Under the 

Paperwork Reduction Act of 1995 (the 

PRA), Federal Agencies are required to 

publish notice in the Federal Register 

concerning each proposed collection of 

information, including each proposed 

extension of an existing collection of 

information, and to allow 60 days for 

public comment in response to the 

notice. This notice solicits comments on 

the requirements for drug establishment 

registration and drug listing. 

DATES: Submit either electronic or 

written comments on the collection of 

information by May 22, 2015. 

ADDRESSES: Submit electronic 

comments on the collection of 

information to http://

www.regulations.gov. Submit written 

comments on the collection of 

information to the Division of Dockets 

Management (HFA 305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. All 

comments should be identified with the 

docket number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: FDA 

PRA Staff, Office of Operations, Food 

and Drug Administration, 8455 

Colesville Rd., COLE–14526, Silver 

Spring, MD 20993–0002; PRAStaff@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: Under the 

PRA (44 U.S.C. 3501–3520), Federal 

Agencies must obtain approval from the 

Office of Management and Budget 

(OMB) for each collection of 

information they conduct or sponsor. 

‘‘Collection of information’’ is defined 

in 44 U.S.C. 3502(3) and 5 CFR 

1320.3(c) and includes Agency requests 

or requirements that members of the 

public submit reports, keep records, or 

provide information to a third party. 

Section 3506(c)(2)(A) of the PRA (44 

U.S.C. 3506(c)(2)(A)) requires Federal 

Agencies to provide a 60-day notice in 

the Federal Register concerning each 

proposed collection of information, 

including each proposed extension of an 

existing collection of information, 

before submitting the collection to OMB 

for approval. To comply with this 

requirement, FDA is publishing notice 

of the proposed collection of 

information set forth in this document. 

With respect to the following 

collection of information, FDA invites 

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. 

Registration of Producers of Drugs and 

Listing of Drugs in Commercial 

Distribution—21 CFR Part 207 (OMB 

Control Number 0910–0045)—Extension 

Requirements for drug establishment 

registration and drug listing are set forth 

in section 510 of the Federal Food, 

Drug, and Cosmetic Act (the FD&C Act) 

(21 U.S.C. 360), section 351 of the 

Public Health Service Act (42 U.S.C. 

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Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices 15215 

262), and part 207 (21 CFR part 207). 

Fundamental to FDA’s mission to 

protect the public health is the 

collection of this information, which is 

used for important activities such as 

postmarket surveillance for serious 

adverse drug reactions, inspection of 

drug manufacturing and processing 

facilities, and monitoring of drug 

products imported into the United 

States. Comprehensive, accurate, and up 

to date information is critical to 

conducting these activities with 

efficiency and effectiveness. 

Under section 510 of the FD&C Act, 

FDA is authorized to establish a system 

for registration of producers of drugs 

and for listing of drugs in commercial 

distribution. To implement section 510 

of the FD&C Act, FDA issued part 207. 

Under current § 207.20, manufacturers, 

repackers, and relabelers that engage in 

the manufacture, preparation, 

propagation, compounding, or 

processing of human or veterinary drugs 

and biological products, including bulk 

drug substances and bulk drug 

substances for prescription 

compounding, and drug premixes as 

well as finished dosage forms, whether 

prescription or over-the-counter, are 

required to register their establishment. 

In addition, manufacturers, repackers, 

and relabelers are required to submit a 

listing of every drug or biological 

product in commercial distribution. 

Owners or operators of establishments 

that distribute under their own label or 

trade name a drug product 

manufactured by a registered 

establishment are not required either to 

register or list. However, distributors 

may elect to submit drug listing 

information in lieu of the registered 

establishment that manufactures the 

drug product. Foreign drug 

establishments must also comply with 

the establishment registration and 

product listing requirements if they 

import or offer for import their products 

into the United States. 

Under current § 207.21, 

establishments, both domestic and 

foreign, must register with FDA within 

5 days after beginning the manufacture 

of drugs or biologicals, or within 5 days 

after the submission of a drug 

application or biological license 

application. In addition, establishments 

must register annually. Changes in 

individual ownership, corporate or 

partnership structure, location, or drug 

handling activity must be submitted as 

amendments to registration under 

current § 207.26 within 5 days of such 

changes. Under § 207.20(b), private label 

distributors may request their own 

labeler code and elect to submit drug 

listing information to FDA. In such 

instances, at the time of submitting or 

updating drug listing information, 

private label distributors must certify to 

the registered establishment that 

manufactured, prepared, propagated, 

compounded, or processed (which 

includes, among other things, 

repackaging and relabeling) the listed 

drug that the drug listing submission 

was made. Establishments must, within 

5 days of beginning the manufacture of 

drugs or biologicals, submit to FDA a 

listing for every drug or biological 

product in commercial distribution at 

that time. Private label distributors may 

elect to submit to FDA a listing of every 

drug product they place in commercial 

distribution. Registered establishments 

must submit to FDA drug product 

listing for those private label 

distributors who do not elect to submit 

listing information. 

Under § 207.25, product listing 

information submitted to FDA by 

domestic and foreign manufacturers 

must, depending on the type of product 

being listed, include any new drug 

application number or biological 

establishment license number, copies of 

current labeling and a sampling of 

advertisements, a quantitative listing of 

the active ingredient for each drug or 

biological product not subject to an 

approved application or license, the 

NDC number, and any drug imprinting 

information. 

In addition to the product listing 

information required, FDA may also 

require, under § 207.31, a copy of all 

advertisements and a quantitative listing 

of all ingredients for each listed drug or 

biological product not subject to an 

approved application or license; the 

basis for a determination, by the 

establishment, that a listed drug or 

biological product is not subject to 

marketing or licensing approval 

requirements; and a list of certain drugs 

or biological products containing a 

particular ingredient. FDA may also 

request, but not require, the submission 

of a qualitative listing of the inactive 

ingredients for all listed drugs or 

biological products, and a quantitative 

listing of the active ingredients for all 

listed drugs or biological products 

subject to an approved application or 

license. 

Under § 207.30, establishments must 

update their product listing information 

every June and December or, at the 

discretion of the establishment, when 

any change occurs. These updates must 

include the following information: (1) A 

listing of all drug or biological products 

introduced for commercial distribution 

that have not been included in any 

previously submitted list; (2) all drug or 

biological products formerly listed for 

which commercial distribution has been 

discontinued; (3) all drug or biological 

products for which a notice of 

discontinuance was submitted and for 

which commercial distribution has been 

resumed; and (4) any material change in 

any information previously submitted. 

No update is required if no changes 

have occurred since the previously 

submitted list. 

Historically, drug establishment 

registration and drug listing information 

have been submitted in paper form 

using Form FDA 2656 (Registration of 

Drug Establishment/Labeler Code 

Assignment), Form FDA 2657 (Drug 

Product Listing), and Form FDA 2658 

(Registered Establishments’ Report of 

Private Label Distributors) (collectively 

referred to as FDA Forms). Changes in 

the FD&C Act resulting from enactment 

of the Food and Drug Administration 

Amendments Act of 2007 (Pub. L. 110– 

85) (FDAAA) require that drug 

establishment registration and drug 

listing information be submitted 

electronically unless a waiver is 

granted. Before the enactment of 

FDAAA, section 510(p) of the FD&C Act 

expressly provided for electronic 

submission of drug establishment 

registration information upon a finding 

that electronic receipt was feasible, and 

section 510(j) of the FD&C Act provided 

that drug listing information be 

submitted in the form and manner 

prescribed by FDA. Section 224 of 

FDAAA, which amends section 510(p) 

of the FD&C Act, now expressly, 

requires electronic drug listing in 

addition to drug establishment 

registration. In certain cases, if it is 

unreasonable to expect a person to 

submit registration and listing 

information electronically, FDA may 

grant a waiver from the electronic 

format requirement. 

In the Federal Register of June 1, 2009 

(74 FR 26248), FDA announced the 

availability of a guidance for industry 

entitled ‘‘Providing Regulatory 

Submissions in Electronic Format— 

Drug Establishment Registration and 

Drug Listing’’ (the 2009 guidance). The 

document provides guidance to industry 

on the statutory requirement to submit 

electronically drug establishment 

registration and drug listing 

information. The guidance describes the 

types of information to include for 

purposes of drug establishment 

registration and drug listing and how to 

prepare and submit the information in 

an electronic format (Structured Product 

Labeling (SPL) files) that FDA can 

process, review, and archive. In 

addition to the information that 

previously was collected on the FDA 

Forms, the guidance addresses 

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15216 Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices 

electronic submission of other required 

information as follows: 

• For registered foreign drug 

establishments, the name, address, and 

telephone number of its U.S. agent 

(§ 207.40(c)); 

• the name of each importer that is 

known to the establishment (the U.S. 

company or individual in the United 

States that is an owner, consignee, or 

recipient of the foreign establishment’s 

drug that is imported into the United 

States. An importer does not include the 

consumer or patient who ultimately 

purchases, receives, or is administered 

the drug, unless the foreign 

establishment ships the drug directly to 

the consumer or the patient) (section 

510(i)(1)(A) of the FD&C Act); and 

• the name of each person who 

imports or offers for import (the name 

of each agent, broker, or other entity, 

other than a carrier, that the foreign 

drug establishment uses to facilitate the 

import of their drug into the United 

States) (section 510(i)(1)(A) of the FD&C 

Act). 

FDA also recommends the voluntary 

submission of the following additional 

information, when applicable: 

• To facilitate correspondence 

between foreign establishments and 

FDA, the email address for the U.S. 

agent, and the telephone number(s) and 

email address for the importer and 

person who imports or offers for import 

their drug; 

• a site-specific Data Universal 

Numbering System number for each 

entity (e.g., the registrant, 

establishments, U.S. agent, importer); 

• the NDC product code for the 

source drug that is repacked or 

relabeled; 

• distinctive characteristics of certain 

listed drugs, i.e., the flavor, the color, 

and image of the actual solid dosage 

form; and 

• registrants may indicate that they 

view as confidential the registrant’s 

business relationship with an 

establishment, or an inactive ingredient. 

In addition to this collection of 

information, there is an additional 

burden for the following activities: 

• preparing a standard operating 

procedure (SOP) for the electronic 

submission of drug establishment 

registration and drug listing 

information; 

• creating the SPL file, including 

accessing and reviewing the technical 

specifications and instructional 

documents provided by FDA (accessible 

at http://www.fda.gov/oc/datacouncil/

spl.html); 

• reviewing and selecting appropriate 

terms and codes used to create the SPL 

file (accessible at http://www.fda.gov/

oc/datacouncil/spl.html); 

• obtaining the digital certificate used 

with FDA’s electronic submission 

gateway and uploading the SPL file for 

submission (accessible at http://

www.fda.gov/esg/default.htm); and 

• requests for waivers from the 

electronic submission process as 

described in the draft guidance. 

When FDA published the 2009 

guidance on submitting establishment 

registration and drug listing information 

in electronic format, the Agency also 

amended its burden estimates for OMB 

control number 0910–0045 to include 

the additional burden for the collection 

of information that had not been 

submitted using the FDA forms, and to 

create and upload the SPL file. The 

amended burden estimates included the 

one-time preparation of an SOP for 

creating and uploading the SPL file. 

Although most firms will already have 

prepared an SOP for the electronic 

submission of drug establishment 

registration and drug listing 

information, each year additional firms 

will need to create an SOP. As provided 

in Table 2 of this document, FDA 

estimates that approximately 1,000 

firms will have to expend a one-time 

burden to prepare, review, and approve 

an SOP, and the Agency estimates that 

it will take 40 hours per recordkeeper to 

create 1,000 new SOPs for a total of 

40,000 hours. 

In Tables 1 and 2, the information 

collection requirements of the drug 

establishment registration and drug 

listing requirements have been grouped 

according to the information collection 

areas of the requirements. 

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Activity Number of 

respondents 

Number of 

responses per 

respondent 

Total annual 

responses 

Average 

burden per 

response 

Total hours 

New registrations, including new labeler codes requests ... 1,400 2 2,800 4.5 12,600 

Annual updates of registration information .......................... 10,000 1 10,000 4.5 45,000 

New drug listings ................................................................. 1,567 7 11,000 4.5 49,500 

New listings for private label distributor ............................... 146 10.06 1,469 4.5 6,611 

June and December updates of all drug listing information 5,300 20 106,000 4.5 477,000 

Waiver requests ................................................................... 1 1 1 1 1 

Total .............................................................................. ........................ ........................ ........................ ........................ 590,712 

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

TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Activity resulting from section 510(p) of the FD&C Act as 

amended by FDAAA 

Number of 

recordkeepers 

Number of 

records per 

recordkeeper 

Total annual 

records 

Average 

burden per 

recordkeeping 

Total hours 

One-time preparation of SOP .............................................. 1,000 1 1,000 40 40,000 

SOP maintenance ................................................................ 3,295 1 3,295 1 3,295 

Total .............................................................................. ........................ ........................ ........................ ........................ 43,295 

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

mstockstill on DSK4VPTVN1PROD with NOTICES

Federal Register / Vol. 80, No. 55 / Monday, March 23, 2015 / Notices 15217 

Dated: March 17, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–06497 Filed 3–20–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2014–D–1288] 

Electronic Submission of Lot 

Distribution Reports; Guidance for 

Industry; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a document entitled 

‘‘Electronic Submission of Lot 

Distribution Reports; Guidance for 

Industry.’’ The guidance document 

provides information and 

recommendations pertaining to the 

electronic submission of lot distribution 

reports for applicants with approved 

biologics license applications (BLAs). 

FDA recently published in the Federal 

Register a final rule requiring that, 

among other things, lot distribution 

reports be submitted to FDA in an 

electronic format that the Agency can 

process, review, and archive. The 

guidance announced in this notice 

finalizes the draft guidance entitled 

‘‘Guidance for Industry: Electronic 

Submission of Lot Distribution Reports’’ 

dated August 2014, and is intended to 

help licensed manufacturers of products 

distributed under an approved BLA 

(henceforth referred to as applicants) 

comply with the final rule. 

DATES: Submit either electronic or 

written comments on Agency guidances 

at any time. 

ADDRESSES: Submit written requests for 

single copies of the guidance to the 

Office of Communication, Outreach and 

Development, Center for Biologics 

Evaluation and Research (CBER), Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 3128, 

Silver Spring, MD 20993–0002 or 

Division of Drug Information, Center for 

Drug Evaluation and Research (CDER), 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 51, Rm. 

2201, Silver Spring, MD 20993–0002. 

Send one self-addressed adhesive label 

to assist the office in processing your 

requests. The guidance may also be 

obtained by mail by calling CBER at 1– 

800–835–4709 or 240–402–7800. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance 

document. 

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: Lori 

J. Churchyard, Center for Biologics 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 71, Rm. 7301, 

Silver Spring, MD 20993–0002, 240– 

402–7911; or Jared Lantzy, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 22, Rm. 1116, 

Silver Spring, MD 20993, email: esub@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

FDA is announcing the availability of 

a document entitled ‘‘Electronic 

Submission of Lot Distribution Reports; 

Guidance for Industry.’’ The guidance 

provides information and 

recommendations pertaining to the 

electronic submission of lot distribution 

reports. The guidance provides 

information on how to electronically 

submit lot distribution reports for 

biological products under approved 

BLAs for which CBER or CDER has 

regulatory responsibility. The guidance 

does not apply to any other biological 

product. 

FDA published in the Federal 

Register of June 10, 2014 (79 FR 33072), 

a final rule requiring electronic 

submission of certain postmarketing 

submissions. Among other things, under 

this rule applicants are required to 

submit biological lot distribution reports 

to FDA in an electronic format that the 

Agency can process, review, and 

archive. The guidance is intended to 

help applicants subject to lot 

distribution reporting comply with the 

final rule. Along with other information, 

the guidance provides updated 

information about the following: (1) 

Structured Product Labeling standard 

and vocabulary for electronic 

submission of lot distribution reporting; 

(2) additional resources such as 

implementation guide, validation 

procedures and links with further 

information; and (3) procedures for 

requesting temporary waivers from the 

electronic submission requirement. 

In the Federal Register of August 29, 

2014 (79 FR 51576), FDA announced the 

availability of the draft guidance 

entitled ’’ Guidance for Industry: 

Electronic Submission of Lot 

Distribution Reports’’ dated August 

2014. FDA published a correction notice 

to correct the docket number in the 

Federal Register of September 16, 2014 

(79 FR 55497). FDA received a few 

comments on the draft guidance and 

those comments were considered as the 

guidance was finalized. FDA is 

finalizing the draft guidance with only 

editorial changes. The guidance 

announced in this notice finalizes the 

draft guidance dated August 2014. 

The guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents FDA’s current 

thinking on this topic. 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 

This guidance refers to previously 

approved collections of information 

found in FDA regulations. These 

collections of information 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 collections of information in 

21 CFR 600.81 and 600.90 have been 

approved under 0910–0308. 

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 guidance at either http:// 

www.fda.gov/BiologicsBloodVaccines/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, http://www.fda.gov/Drugs/

GuidanceCompliance

RegulatoryInformation/Guidances/

default.htm, or http://

www.regulations.gov. 

mstockstill on DSK4VPTVN1PROD with NOTICES