81 FR 44868 - Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Form FDA 356h

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 132 (July 11, 2016)

Page Range		44868-44872
FR Document		2016-16352
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 collection of information relating to general licensing provisions for biologics license applications (BLAs), changes to an approved application, labeling, revocation and suspension, postmarketing studies status reports, and Form FDA 356h.
Federal Register, Volume 81 Issue 132 (Monday, July 11, 2016)
[Federal Register Volume 81, Number 132 (Monday, July 11, 2016)]
[Notices]
[Pages 44868-44872]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-16352]



[[Page 44868]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0578]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; General Licensing Provisions: Biologics License 
Application, Changes to an Approved Application, Labeling, Revocation 
and Suspension, Postmarketing Studies Status Reports, and Form FDA 356h

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 collection of information 
relating to general licensing provisions for biologics license 
applications (BLAs), changes to an approved application, labeling, 
revocation and suspension, postmarketing studies status reports, and 
Form FDA 356h.

DATES: Submit electronic or written comments on the collection of 
information by September 9, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
    Mail/Hand delivery/Courier (for written/paper submissions): 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2013-N-0578 for ``General Licensing Provisions: Biologics License 
Application, Changes to an Approved Application, Labeling, Revocation 
and Suspension, Postmarketing Studies Status Reports and Form FDA 
356h.'' Received comments will be placed in the docket and, except for 
those submitted as ``Confidential Submissions,'' publicly viewable at 
http://www.regulations.gov or at the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, Three White Flint North 10A-12M, 11601 
Landsdown St., North Bethesda, MD 20852, 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

[[Page 44869]]

of automated collection techniques, when appropriate, and other forms 
of information technology.

General Licensing Provisions: Biologics License Application, Changes to 
an Approved Application, Labeling, Revocation and Suspension, 
Postmarketing Studies Status Reports, and Form FDA 356h

OMB Control No. 0910-0338--Extension

    Under section 351 of the Public Health Services Act (the PHS Act) 
(42 U.S.C. 262), manufacturers of biological products must submit a 
license application for FDA review and approval before marketing a 
biological product in interstate commerce. Licenses may be issued only 
upon showing that the establishment and the products for which a 
license is desired meets standards prescribed in regulations designed 
to ensure the continued safety, purity, and potency of such products. 
All such licenses are issued, suspended, and revoked as prescribed by 
regulations in part 601 (21 CFR part 601).
    Section 130(a) of the Food and Drug Administration Modernization 
Act (Pub. L. 105-115) amended the Federal Food, Drug, and Cosmetic Act 
(the FD&C Act) by adding a new provision (section 506B of the FD&C Act 
(21 U.S.C. 356b)) requiring reports of postmarketing studies for 
approved human drugs and licensed biological products. Section 506B of 
the FD&C Act provides FDA with additional authority to monitor the 
progress of postmarketing studies that applicants have made a 
commitment to conduct and requires the Agency to make publicly 
available information that pertains to the status of these studies. 
Under section 506B(a) of the FD&C Act, applicants that have committed 
to conduct a postmarketing study for an approved human drug or licensed 
biological product must submit to FDA a status report of the progress 
of the study or the reasons for the failure of the applicant to conduct 
the study. This report must be submitted within 1 year after the U.S. 
approval of the application and then annually until the study is 
completed or terminated.
    A summary of the collection of information requirements follows:
    Section 601.2(a) requires a manufacturer of a biological product to 
submit an application on forms prescribed for such purposes with 
accompanying data and information, including certain labeling 
information, to FDA for approval to market a product in interstate 
commerce. The container and package labeling requirements are provided 
under Sec. Sec.  610.60 through 610.65 (21 CFR 610.60 through 610.65). 
The estimate for these regulations is included in the estimate under 
Sec.  601.2(a) in table 1.
    Section 601.5(a) requires a manufacturer to submit to FDA notice of 
its intention to discontinue manufacture of a product or all products. 
Section 601.6(a) requires the manufacturer to notify selling agents and 
distributors upon suspension of its license, and provide FDA of such 
notification.
    Section 601.12(a)(2) requires, generally, that the holder of an 
approved BLA must assess the effects of a manufacturing change before 
distributing a biological product made with the change. Section 
601.12(a)(4) requires, generally, that the applicant must promptly 
revise all promotional labeling and advertising to make it consistent 
with any labeling changes implemented. Section 601.12(a)(5) requires 
the applicant to include a list of all changes contained in the 
supplement or annual report; for supplements, this list must be 
provided in the cover letter. The burden estimates for Sec.  
601.12(a)(2) are included in the estimates for supplements (Sec. Sec.  
601.12(b) and (c)) and annual reports (Sec.  601.12(d)). The burden 
estimates for Sec.  601.12(a)(4) are included in the estimates under 
601.12(f)(4) in table 1.
    Sections 601.12(b)(1) and (3), (c)(1), (3), and (5), and (d)(1) and 
(3) require applicants to follow specific procedures to submit 
information to FDA of any changes, in the product, production process, 
quality controls, equipment, facilities, or responsible personnel 
established in an approved license application. The appropriate 
procedure depends on the potential for the change to have a 
substantial, moderate, or minimal adverse effect on the identity, 
strength, quality, purity, or potency of the products as they may 
relate to the safety or effectiveness of the product. Under Sec.  
601.12(b)(4), an applicant may ask FDA to expedite its review of a 
supplement for public health reasons or if a delay in making the change 
described in it would impose an extraordinary hardship of the 
applicant. The burden estimate for Sec.  601.12(b)(4) is minimal and 
included in the estimate under Sec.  601.12(b)(1) and (3) in table 1.
    Section 601.12(e) requires applicants to submit a protocol, or 
change to a protocol, as a supplement requiring FDA approval before 
distributing the product. Section 601.12(f)(1) through (3) requires 
applicants to follow specific procedures to report certain labeling 
changes to FDA. Section 601.12(f)(4) requires applicants to report to 
FDA advertising and promotional labeling and any changes.
    Under Sec.  601.14, the content of labeling required in 21 CFR 
201.100(d)(3) must be in electronic format and in a form that FDA can 
process, review, and archive. This requirement is in addition to the 
provisions of Sec. Sec.  601.2(a) and 601.12(f). The burden estimate 
for Sec.  601.14 is minimal and included in the estimate under 
Sec. Sec.  601.2(a) (BLAs) and 601.12(f)(1) through (3) (labeling 
supplements and annual reports) in table 1.
    Section 601.45 requires applicants of biological products for 
serious or life-threatening illnesses to submit to the Agency for 
consideration, during the pre-approval review period, copies of all 
promotional materials, including promotional labeling as well as 
advertisements.
    In addition to Sec. Sec.  601.2 and 601.12, there are other 
regulations in 21 CFR parts 640, 660, and 680 that relate to 
information to be submitted in a license application or supplement for 
certain blood or allergenic products as follows: Sec. Sec.  640.6; 
640.17; 640.21(c); 640.22(c); 640.25(c); 640.56(c); 640.64(c); 
640.74(a) and (b)(2); 660.51(a)(4); and 680.1(b)(2)(iii) and (d).
    In table 1, the burden associated with the information collection 
requirements in the applicable regulations is included in the burden 
estimate for Sec. Sec.  601.2 and/or 601.12. A regulation may be listed 
under more than one subsection of Sec.  601.12 due to the type of 
category under which a change to an approved application may be 
submitted.
    There are also additional container and/or package labeling 
requirements for certain licensed biological products including: Sec.  
640.74(b)(3) and (4) for Source Plasma Liquid; Sec.  640.84(a) and (c) 
for Albumin; Sec.  640.94(a) for Plasma Protein Fraction; Sec.  
660.2(c) for Antibody to Hepatitis B Surface Antigen; Sec.  660.28(a), 
(b), and (c) for Blood Grouping Reagent; Sec.  660.35(a), (c through 
g), and (i through m) for Reagent Red Blood Cells; Sec.  660.45 for 
Hepatitis B Surface Antigen; and Sec.  660.55(a) and (b) for Anti-Human 
Globulin. The burden associated with the additional labeling 
requirements for submission of a license application for these certain 
biological products is minimal because the majority of the burden is 
associated with the requirements under Sec. Sec.  610.60 through 610.65 
or 21 CFR 809.10. Therefore, the burden estimates for these regulations 
are included in the estimate under Sec. Sec.  610.60 through 610.65 in 
table 1. The burden estimates associated with Sec.  809.10 are approved 
under OMB control number 0910-0485.

[[Page 44870]]

    Section 601.27(a) requires that applications for new biological 
products contain data that are adequate to assess the safety and 
effectiveness of the biological product for the claimed indications in 
pediatric subpopulations, and to support dosing and administration 
information. Section 601.27(b) provides that an applicant may request a 
deferred submission of some or all assessments of safety and 
effectiveness required under Sec.  601.27(a) until after licensing the 
product for use in adults. Section 601.27(c) provides that an applicant 
may request a full or partial waiver of the requirements under Sec.  
601.27(a) with adequate justification. The burden estimates for Sec.  
601.27(a) are included in the burden estimate under Sec.  601.2(a) in 
table 1 since these regulations deal with information to be provided in 
an application.
    Section 601.28 requires sponsors of licensed biological products to 
submit the information in Sec.  601.28(a), (b), and (c) to the Center 
for Biologics Evaluation and Research (CBER) or to the Center for Drug 
Evaluation and Research (CDER) each year, within 60 days of the 
anniversary date of approval of the license. Section 601.28(a) requires 
sponsors to submit to FDA a brief summary stating whether labeling 
supplements for pediatric use have been submitted and whether new 
studies in the pediatric population to support appropriate labeling for 
the pediatric population have been initiated. Section 601.28(b) 
requires sponsors to submit to FDA an analysis of available safety and 
efficacy data in the pediatric population and changes proposed in the 
labeling based on this information. Section 601.28(c) requires sponsors 
to submit to FDA a statement on the current status of any postmarketing 
studies in the pediatric population performed by, on or behalf of, the 
applicant. If the postmarketing studies were required or agreed to, the 
status of these studies is to be reported under Sec.  601.70 rather 
than under this section.
    Sections 601.33 through 601.35 clarify the information to be 
submitted in an application to FDA to evaluate the safety and 
effectiveness of radiopharmaceuticals intended for in vivo 
administration for diagnostic and monitoring use. The burden estimates 
for Sec. Sec.  601.33 through 601.35 are included in the burden 
estimate under Sec.  601.2(a) in table 1 since these regulations deal 
with information to be provided in an application.
    Section 601.70(b) requires each applicant of a licensed biological 
product to submit annually a report to FDA on the status of 
postmarketing studies for each approved product application. Each 
annual postmarketing status report must be accompanied by a completed 
transmittal Form FDA 2252 (Form FDA 2252 approved under OMB control 
number 0910-0001). Under Sec.  601.70(d), two copies of the annual 
report shall be submitted to FDA.
    Sections 601.91 through 601.94 concern biological products for 
which human efficacy studies are not ethical or feasible. Section 
601.91(b)(2) requires, in certain circumstances, such postmarking 
restrictions as are needed to ensure the safe use of the biological 
product. Section 601.91(b)(3) requires applicants to prepare and 
provide labeling with relevant information to patients or potential 
patients for biological products approved under part 601, subpart H, 
when human efficacy studies are not ethical or feasible (or based on 
evidence of effectiveness from studies in animals). Section 601.93 
provides that biological products approved under subpart H are subject 
to the postmarketing recordkeeping and safety reporting applicable to 
all approved biological products. Section 601.94 requires applicants 
under subpart H to submit to the Agency for consideration during 
preapproval review period copies of all promotional materials including 
promotional labeling as well as advertisements. Under Sec. Sec.  
601.91(b)(2) and 601.93, any potential postmarketing reports and/or 
recordkeeping burdens would be included under the adverse experience 
reporting (AER) requirements under 21 CFR part 600 (OMB control number 
0910-0308). Therefore, any burdens associated with these requirements 
would be reported under the AER information collection requirements 
(OMB control number 0910-0308). The burden estimate for Sec.  
601.91(b)(3) is included in the estimate under Sec. Sec.  610.60 
through 610.65.
    Section 610.9(a) requires the applicant to present certain 
information, in the form of a license application or supplement to the 
application, for a modification of any particular test method or 
manufacturing process or the conditions which it is conducted under the 
biologics regulations. The burden estimate for Sec.  610.9(a) is 
included in the estimate under Sec. Sec.  601.2(a) and 601.12(b) and 
(c) in table 1.
    Under Sec.  610.15(d), the Director of CBER or the Director of CDER 
may approve, as appropriate, a manufacturer's request for exceptions or 
alternatives to the regulation for constituent materials. Manufacturers 
seeking approval of an exception or alternative must submit a request 
in writing with a brief statement describing the basis for the request 
and the supporting data.
    Section 640.120 requires licensed establishments to submit a 
request for an exception or alternative to any requirement in the 
biologics regulations regarding blood, blood components, or blood 
products. For licensed establishments, a request for an exception or 
alternative must be submitted in accordance with Sec.  601.12; 
therefore, the burden estimate for Sec.  640.120 is included in the 
estimate under Sec.  601.12(b) in table 1.
    Section 680.1(c) requires manufacturers to update annually their 
license file with the list of source materials and the suppliers of the 
materials. Section 680.1(b)(3)(iv) requires manufacturers to notify FDA 
when certain diseases are detected in source materials.
    Sections 600.15(b) and 610.53(d) require the submission of a 
request for an exemption or modification regarding the temperature 
requirements during shipment and from dating periods, respectively, for 
certain biological products. Section 606.110(b) (21 CFR 606.110(b)) 
requires the submission of a request for approval to perform 
plasmapheresis of donors who do not meet certain donor requirements for 
the collection of plasma containing rare antibodies. Under Sec. Sec.  
600.15(b), 610.53(d), and 606.110(b), a request for an exemption or 
modification to the requirements would be submitted as a supplement. 
Therefore, the burden hours for any submissions under Sec. Sec.  
600.15(b), 610.53(d), and 606.110(b) are included in the estimates 
under Sec.  601.12(b) in table 1.
    In July 1997, FDA revised Form FDA 356h ``Application to Market a 
New Drug, Biologic, or an Antibiotic Drug for Human Use'' to harmonize 
application procedures between CBER and CDER. The application form 
serves primarily as a checklist for firms to gather and submit certain 
information to FDA. As such, the form, now entitled ``Application to 
Market a New or Abbreviated New Drug or Biologic for Human Use,'' helps 
to ensure that the application is complete and contains all the 
necessary information so that delays due to lack of information may be 
eliminated. In addition, the form provides key information to FDA for 
efficient handling and distribution to the appropriate staff for 
review. The estimated burden hours for nonbiological product 
submissions to CDER using FDA Form 356h are approved under OMB control 
number 0910-0001 (an estimated 3,200 submissions x 24 hours = 76,800 
hours).

[[Page 44871]]

    For advertisements and promotional labeling (e.g., circulars, 
package labels, container labels, etc.) and labeling changes, 
manufacturers of licensed biological products may submit to CBER or 
CDER Form FDA 2253. In August of 1998, FDA revised and harmonized Form 
FDA 2253 so the form may be used to transmit specimens of promotional 
labeling and advertisements for biological products as well as for 
prescription drugs and antibiotics. The revised, harmonized form 
updates the information about the types of promotional materials and 
the codes that are used to clarify the type of advertisement or 
labeling submitted, clarifies the intended audience for the 
advertisements or promotional labeling (e.g., consumers, professionals, 
news services), and helps ensure that the submission is complete. Form 
FDA 2253 can also be submitted electronically. Form FDA 2253 is 
approved under OMB control number 0910-0001.
    Respondents to this collection of information are manufacturers of 
biological products. Under tables 1 and 2, the numbers of respondents 
are based on the estimated annual number of manufacturers that 
submitted the required information to FDA or the number of submissions 
FDA received in fiscal year (FY) 2015. Based on information obtained 
from FDA's database systems, there are an estimated 391 licensed 
biologics manufacturers. The total annual responses are based on the 
estimated number of submissions (i.e., license applications, labeling 
and other supplements, protocols, advertising and promotional labeling, 
notifications) for a particular product received annually by FDA. The 
hours per response are based on information provided by industry and 
past FDA experience with the various submissions or notifications. The 
hours per response include the time estimated to prepare the various 
submissions or notifications to FDA, and, as applicable, the time 
required to fill out the appropriate form and collate the 
documentation. Additional information regarding these estimates is 
provided below as necessary.
    Under Sec. Sec.  601.2 and 601.12, the estimated hours per response 
are based on the average number of hours to submit the various 
submissions. The estimated average number of hours is based on the 
range of hours to complete a very basic application or supplement and a 
complex application or supplement.
    Under section 601.6(a), the total annual responses are based on FDA 
estimates that establishments may notify an average of 20 selling 
agents and distributors of such suspension, and provide FDA of such 
notification. The number of respondents is based on the estimated 
annual number of suspensions of a biologic license. In table 1, FDA is 
estimating one in case a suspension occurs.
    Under Sec. Sec.  601.12(f)(4) and 601.45, manufacturers of 
biological products may use Form FDA 2253 to submit advertising and 
promotional labeling (which can include multiple pieces). Based on 
information obtained from FDA's database system, there were an 
estimated 11,676 submissions using Form FDA 2253 of advertising and 
promotional labeling from 114 respondents.
    Under Sec. Sec.  601.28 and 601.70(b), FDA estimates that it takes 
an applicant approximately 24 hours (8 hours per study x 3 studies) 
annually to gather, complete, and submit the appropriate information 
for each postmarketing status report (approximately two to four studies 
per report) and the accompanied transmittal Form FDA 2252. Included in 
these 24 hours is the time necessary to prepare and submit two copies 
of the annual progress report of postmarketing studies to FDA under 
Sec.  601.70(d). For FY 2015, there were 139 reports from 82 
respondents.
    Under Sec.  610.15(d), FDA has received no submissions since the 
implementation of the final rule in April 2011. Therefore, FDA is 
estimating 1 respondent and 1 annual request to account for a possible 
submission to CBER or CDER of a request for an exception or alternative 
for constituent materials under Sec.  610.15(d).
    There were a total of 2,777 amendments to an unapproved application 
or supplement and resubmissions submitted using Form FDA 356h.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                    Number of
            21 CFR section                   Form FDA No.           Number of     responses per   Total annual     Average  burden per      Total hours
                                                                   respondents     respondent       responses            response              \10\
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.2(a) \2\, 610.60 through 610.65    356h....................              28            1.36              38  860....................          32,680
 \3\.
601.5(a).............................  N/A.....................              12            0.75               9  0.33 (20 minutes)......               3
601.6(a).............................  N/A.....................               1               1               1  1......................               1
601.12(a)(5).........................  N/A.....................             537           24.41          13,108  1......................          13,108
601.12(b)(1)/(b)(3)/(e)..............  356h \2\................             164            3.66             600  80.....................          48,000
601.12(c)(1)/(c)(3) \5\..............  356h \2\................             120            4.78             574  50.....................          28,700
601.12(c)(5).........................  356h \2\................               7            1.14               8  50.....................             400
601.12(d)(1)/(d)(3) \6\/(f)(3) \8\...  356h \2\................             246            3.34             822  24.....................          19,728
601.12(f)(1) \7\.....................  2253....................              72            1.93             139  40.....................           5,560
601.12(f)(2) \7\.....................  2253....................              60            1.82             109  20.....................           2,180
601.12(f)(4)/601.45 \9\..............  2253....................             114          102.42          11,676  10.....................         116,670
601.27(b)............................  N/A.....................              20           16.50             330  24.....................           7,920
601.27(c)............................  N/A.....................              12            1.08              13  8......................             104
601.70(b) and (d)/601.28.............  2252....................              82            1.70             139  24.....................           3,336
610.15(d)............................  N/A.....................               1               1               1  1......................               1
680.1(c).............................  N/A.....................               9               1               9  2......................              18
680.1(b)(3)(iv)......................  N/A.....................               1               1               1  2......................               2
Amendments/Resubmissions.............  356h....................             125           22.22           2,777  20.....................          55,540
                                                                ----------------------------------------------------------------------------------------
    Total............................  ........................  ..............  ..............  ..............  .......................         333,951
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The reporting requirements under Sec.  Sec.   601.14, 601.27(a), 601.33, 601.34, 601.35, 610.9(a), 640.17, 640.25(c),
640.56(c), 640.74(b)(2), 660.51(a)(4), and 680.1(b)(2)(iii) are included in the estimate under Sec.   601.2(a).
\3\ The reporting requirements under Sec.  Sec.   601.93(b)(3), 640.70(a), 640.74(b)(3) and (4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a), (b),
  and (c), 660.35(a), (c through g), and (i through m), 660.45, and 660.55(a) and (b) are included under Sec.  Sec.   610.60 through 610.65.

[[Page 44872]]

 
\4\ The reporting requirements under Sec.  Sec.   601.12(a)(2) and (b)(4), 600.15(b), 610.9(a), 610.53(d), 606.110(b), 640.6, 640.17, 640.21(c),
  640.22(c), 640.25(c), 640.56(c), 640.64(c), 640.74(a) and (b)(2), 640.120, and 680.1(d) are included in the estimate under Sec.   601.12(b).
\5\ The reporting requirements under Sec.  Sec.   601.12(a)(2), 610.9(a), 640.17, 640.25(c), 640.56(c), and 640.74(b)(2) are included in the estimate
  under Sec.   601.12(c).
\6\ The reporting requirement under Sec.   601.12(a)(2) is included in the estimate under Sec.   601.12(d).
\7\ The reporting requirement under Sec.   601.14 is included in the estimate under Sec.   601.12(f)(1) and (2).
\8\ The reporting requirement under Sec.  Sec.   601.12(a)(4) and 601.14 is included in the estimate under Sec.   601.12(f)(3).
\9\ The reporting requirement under Sec.   601.94 is included in the estimate under Sec.   601.45.
\10\ The numbers in this column have been rounded to the nearest whole number.

    Under table 2, the estimated recordkeeping burden of 1 hour is 
based on previous estimates for the recordkeeping requirements 
associated with the AER system.

                                               Table 2--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                        Annual
                 21 CFR section                      Number of     disclosures per    Total annual      Average burden per disclosure    Total hours \2\
                                                    respondents       respondent      disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
601.6(a)........................................               1               20               20   0.33 (20 minutes).................               7
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Rounded to the nearest whole number.


    Dated: July 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-16352 Filed 7-8-16; 8:45 am]
 BILLING CODE 4164-01-P
Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices 44869

of automated collection techniques, 610.65 (21 CFR 610.60 through 610.65). Under § 601.14, the content of
when appropriate, and other forms of The estimate for these regulations is labeling required in 21 CFR
information technology. included in the estimate under 201.100(d)(3) must be in electronic
§ 601.2(a) in table 1. format and in a form that FDA can
General Licensing Provisions: Biologics Section 601.5(a) requires a process, review, and archive. This
License Application, Changes to an manufacturer to submit to FDA notice of requirement is in addition to the
Approved Application, Labeling, its intention to discontinue manufacture provisions of §§ 601.2(a) and 601.12(f).
Revocation and Suspension, of a product or all products. Section The burden estimate for § 601.14 is
Postmarketing Studies Status Reports, 601.6(a) requires the manufacturer to minimal and included in the estimate
and Form FDA 356h notify selling agents and distributors under §§ 601.2(a) (BLAs) and
OMB Control No. 0910–0338—Extension upon suspension of its license, and 601.12(f)(1) through (3) (labeling
provide FDA of such notification. supplements and annual reports) in
Under section 351 of the Public Section 601.12(a)(2) requires,
Health Services Act (the PHS Act) (42 table 1.
generally, that the holder of an Section 601.45 requires applicants of
U.S.C. 262), manufacturers of biological approved BLA must assess the effects of
products must submit a license biological products for serious or life-
a manufacturing change before threatening illnesses to submit to the
application for FDA review and distributing a biological product made
approval before marketing a biological Agency for consideration, during the
with the change. Section 601.12(a)(4) pre-approval review period, copies of all
product in interstate commerce. requires, generally, that the applicant
Licenses may be issued only upon promotional materials, including
must promptly revise all promotional promotional labeling as well as
showing that the establishment and the labeling and advertising to make it
products for which a license is desired advertisements.
consistent with any labeling changes In addition to §§ 601.2 and 601.12,
meets standards prescribed in implemented. Section 601.12(a)(5)
regulations designed to ensure the there are other regulations in 21 CFR
requires the applicant to include a list
continued safety, purity, and potency of parts 640, 660, and 680 that relate to
of all changes contained in the
such products. All such licenses are information to be submitted in a license
supplement or annual report; for
issued, suspended, and revoked as application or supplement for certain
supplements, this list must be provided
prescribed by regulations in part 601 (21 blood or allergenic products as follows:
in the cover letter. The burden estimates
CFR part 601). §§ 640.6; 640.17; 640.21(c); 640.22(c);
for § 601.12(a)(2) are included in the
Section 130(a) of the Food and Drug 640.25(c); 640.56(c); 640.64(c); 640.74(a)
estimates for supplements (§§ 601.12(b)
Administration Modernization Act (Pub. and (b)(2); 660.51(a)(4); and
and (c)) and annual reports
L. 105–115) amended the Federal Food, 680.1(b)(2)(iii) and (d).
(§ 601.12(d)). The burden estimates for
Drug, and Cosmetic Act (the FD&C Act) § 601.12(a)(4) are included in the In table 1, the burden associated with
by adding a new provision (section estimates under 601.12(f)(4) in table 1. the information collection requirements
506B of the FD&C Act (21 U.S.C. 356b)) Sections 601.12(b)(1) and (3), (c)(1), in the applicable regulations is included
requiring reports of postmarketing (3), and (5), and (d)(1) and (3) require in the burden estimate for §§ 601.2 and/
studies for approved human drugs and applicants to follow specific procedures or 601.12. A regulation may be listed
licensed biological products. Section to submit information to FDA of any under more than one subsection of
506B of the FD&C Act provides FDA changes, in the product, production § 601.12 due to the type of category
with additional authority to monitor the process, quality controls, equipment, under which a change to an approved
progress of postmarketing studies that facilities, or responsible personnel application may be submitted.
applicants have made a commitment to established in an approved license There are also additional container
conduct and requires the Agency to application. The appropriate procedure and/or package labeling requirements
make publicly available information depends on the potential for the change for certain licensed biological products
that pertains to the status of these to have a substantial, moderate, or including: § 640.74(b)(3) and (4) for
studies. Under section 506B(a) of the minimal adverse effect on the identity, Source Plasma Liquid; § 640.84(a) and
FD&C Act, applicants that have strength, quality, purity, or potency of (c) for Albumin; § 640.94(a) for Plasma
committed to conduct a postmarketing the products as they may relate to the Protein Fraction; § 660.2(c) for Antibody
study for an approved human drug or safety or effectiveness of the product. to Hepatitis B Surface Antigen;
licensed biological product must submit Under § 601.12(b)(4), an applicant may § 660.28(a), (b), and (c) for Blood
to FDA a status report of the progress of ask FDA to expedite its review of a Grouping Reagent; § 660.35(a), (c
the study or the reasons for the failure supplement for public health reasons or through g), and (i through m) for
of the applicant to conduct the study. if a delay in making the change Reagent Red Blood Cells; § 660.45 for
This report must be submitted within 1 described in it would impose an Hepatitis B Surface Antigen; and
year after the U.S. approval of the extraordinary hardship of the applicant. § 660.55(a) and (b) for Anti-Human
application and then annually until the The burden estimate for § 601.12(b)(4) is Globulin. The burden associated with
study is completed or terminated. minimal and included in the estimate the additional labeling requirements for
A summary of the collection of under § 601.12(b)(1) and (3) in table 1. submission of a license application for
information requirements follows: Section 601.12(e) requires applicants these certain biological products is
Section 601.2(a) requires a to submit a protocol, or change to a minimal because the majority of the
manufacturer of a biological product to protocol, as a supplement requiring burden is associated with the
submit an application on forms FDA approval before distributing the requirements under §§ 610.60 through
sradovich on DSK3GDR082PROD with NOTICES

prescribed for such purposes with product. Section 601.12(f)(1) through (3) 610.65 or 21 CFR 809.10. Therefore, the
accompanying data and information, requires applicants to follow specific burden estimates for these regulations
including certain labeling information, procedures to report certain labeling are included in the estimate under
to FDA for approval to market a product changes to FDA. Section 601.12(f)(4) §§ 610.60 through 610.65 in table 1. The
in interstate commerce. The container requires applicants to report to FDA burden estimates associated with
and package labeling requirements are advertising and promotional labeling § 809.10 are approved under OMB
provided under §§ 610.60 through and any changes. control number 0910–0485.

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Section 601.27(a) requires that application. Each annual postmarketing the basis for the request and the
applications for new biological products status report must be accompanied by a supporting data.
contain data that are adequate to assess completed transmittal Form FDA 2252 Section 640.120 requires licensed
the safety and effectiveness of the (Form FDA 2252 approved under OMB establishments to submit a request for
biological product for the claimed control number 0910–0001). Under an exception or alternative to any
indications in pediatric subpopulations, § 601.70(d), two copies of the annual requirement in the biologics regulations
and to support dosing and report shall be submitted to FDA. regarding blood, blood components, or
administration information. Section Sections 601.91 through 601.94 blood products. For licensed
601.27(b) provides that an applicant concern biological products for which establishments, a request for an
may request a deferred submission of human efficacy studies are not ethical or exception or alternative must be
some or all assessments of safety and feasible. Section 601.91(b)(2) requires, submitted in accordance with § 601.12;
effectiveness required under § 601.27(a) in certain circumstances, such therefore, the burden estimate for
until after licensing the product for use postmarking restrictions as are needed § 640.120 is included in the estimate
in adults. Section 601.27(c) provides to ensure the safe use of the biological under § 601.12(b) in table 1.
that an applicant may request a full or product. Section 601.91(b)(3) requires Section 680.1(c) requires
partial waiver of the requirements under applicants to prepare and provide manufacturers to update annually their
§ 601.27(a) with adequate justification. labeling with relevant information to license file with the list of source
The burden estimates for § 601.27(a) are patients or potential patients for materials and the suppliers of the
included in the burden estimate under biological products approved under part materials. Section 680.1(b)(3)(iv)
§ 601.2(a) in table 1 since these 601, subpart H, when human efficacy requires manufacturers to notify FDA
regulations deal with information to be studies are not ethical or feasible (or when certain diseases are detected in
provided in an application. based on evidence of effectiveness from source materials.
Section 601.28 requires sponsors of studies in animals). Section 601.93 Sections 600.15(b) and 610.53(d)
licensed biological products to submit provides that biological products require the submission of a request for
the information in § 601.28(a), (b), and approved under subpart H are subject to an exemption or modification regarding
(c) to the Center for Biologics Evaluation the postmarketing recordkeeping and the temperature requirements during
and Research (CBER) or to the Center for safety reporting applicable to all shipment and from dating periods,
Drug Evaluation and Research (CDER) approved biological products. Section respectively, for certain biological
each year, within 60 days of the 601.94 requires applicants under products. Section 606.110(b) (21 CFR
anniversary date of approval of the subpart H to submit to the Agency for 606.110(b)) requires the submission of a
license. Section 601.28(a) requires consideration during preapproval request for approval to perform
sponsors to submit to FDA a brief review period copies of all promotional plasmapheresis of donors who do not
summary stating whether labeling
materials including promotional meet certain donor requirements for the
supplements for pediatric use have been
labeling as well as advertisements. collection of plasma containing rare
submitted and whether new studies in
Under §§ 601.91(b)(2) and 601.93, any antibodies. Under §§ 600.15(b),
the pediatric population to support
potential postmarketing reports and/or 610.53(d), and 606.110(b), a request for
appropriate labeling for the pediatric
recordkeeping burdens would be an exemption or modification to the
population have been initiated. Section
included under the adverse experience requirements would be submitted as a
601.28(b) requires sponsors to submit to
reporting (AER) requirements under 21 supplement. Therefore, the burden
FDA an analysis of available safety and
CFR part 600 (OMB control number hours for any submissions under
efficacy data in the pediatric population
0910–0308). Therefore, any burdens §§ 600.15(b), 610.53(d), and 606.110(b)
and changes proposed in the labeling
based on this information. Section associated with these requirements are included in the estimates under
601.28(c) requires sponsors to submit to would be reported under the AER § 601.12(b) in table 1.
FDA a statement on the current status of information collection requirements In July 1997, FDA revised Form FDA
any postmarketing studies in the (OMB control number 0910–0308). The 356h ‘‘Application to Market a New
pediatric population performed by, on burden estimate for § 601.91(b)(3) is Drug, Biologic, or an Antibiotic Drug for
or behalf of, the applicant. If the included in the estimate under Human Use’’ to harmonize application
postmarketing studies were required or §§ 610.60 through 610.65. procedures between CBER and CDER.
agreed to, the status of these studies is Section 610.9(a) requires the The application form serves primarily as
to be reported under § 601.70 rather applicant to present certain information, a checklist for firms to gather and
than under this section. in the form of a license application or submit certain information to FDA. As
Sections 601.33 through 601.35 clarify supplement to the application, for a such, the form, now entitled
the information to be submitted in an modification of any particular test ‘‘Application to Market a New or
application to FDA to evaluate the method or manufacturing process or the Abbreviated New Drug or Biologic for
safety and effectiveness of conditions which it is conducted under Human Use,’’ helps to ensure that the
radiopharmaceuticals intended for in the biologics regulations. The burden application is complete and contains all
vivo administration for diagnostic and estimate for § 610.9(a) is included in the the necessary information so that delays
monitoring use. The burden estimates estimate under §§ 601.2(a) and 601.12(b) due to lack of information may be
for §§ 601.33 through 601.35 are and (c) in table 1. eliminated. In addition, the form
included in the burden estimate under Under § 610.15(d), the Director of provides key information to FDA for
§ 601.2(a) in table 1 since these CBER or the Director of CDER may efficient handling and distribution to
sradovich on DSK3GDR082PROD with NOTICES

regulations deal with information to be approve, as appropriate, a the appropriate staff for review. The
provided in an application. manufacturer’s request for exceptions or estimated burden hours for
Section 601.70(b) requires each alternatives to the regulation for nonbiological product submissions to
applicant of a licensed biological constituent materials. Manufacturers CDER using FDA Form 356h are
product to submit annually a report to seeking approval of an exception or approved under OMB control number
FDA on the status of postmarketing alternative must submit a request in 0910–0001 (an estimated 3,200
studies for each approved product writing with a brief statement describing submissions × 24 hours = 76,800 hours).

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Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices 44871

For advertisements and promotional (i.e., license applications, labeling and advertising and promotional labeling
labeling (e.g., circulars, package labels, other supplements, protocols, (which can include multiple pieces).
container labels, etc.) and labeling advertising and promotional labeling, Based on information obtained from
changes, manufacturers of licensed notifications) for a particular product FDA’s database system, there were an
biological products may submit to CBER received annually by FDA. The hours estimated 11,676 submissions using
or CDER Form FDA 2253. In August of per response are based on information Form FDA 2253 of advertising and
1998, FDA revised and harmonized provided by industry and past FDA promotional labeling from 114
Form FDA 2253 so the form may be experience with the various respondents.
used to transmit specimens of submissions or notifications. The hours Under §§ 601.28 and 601.70(b), FDA
promotional labeling and per response include the time estimated estimates that it takes an applicant
advertisements for biological products to prepare the various submissions or approximately 24 hours (8 hours per
as well as for prescription drugs and notifications to FDA, and, as applicable, study × 3 studies) annually to gather,
antibiotics. The revised, harmonized the time required to fill out the complete, and submit the appropriate
form updates the information about the appropriate form and collate the information for each postmarketing
types of promotional materials and the documentation. Additional information status report (approximately two to four
codes that are used to clarify the type of regarding these estimates is provided studies per report) and the accompanied
advertisement or labeling submitted, below as necessary. transmittal Form FDA 2252. Included in
clarifies the intended audience for the Under §§ 601.2 and 601.12, the these 24 hours is the time necessary to
advertisements or promotional labeling estimated hours per response are based prepare and submit two copies of the
(e.g., consumers, professionals, news on the average number of hours to annual progress report of postmarketing
services), and helps ensure that the submit the various submissions. The studies to FDA under § 601.70(d). For
submission is complete. Form FDA 2253 estimated average number of hours is FY 2015, there were 139 reports from 82
can also be submitted electronically. based on the range of hours to complete respondents.
Form FDA 2253 is approved under OMB a very basic application or supplement
Under § 610.15(d), FDA has received
and a complex application or
control number 0910–0001. no submissions since the
supplement.
Respondents to this collection of Under section 601.6(a), the total implementation of the final rule in April
information are manufacturers of annual responses are based on FDA 2011. Therefore, FDA is estimating 1
biological products. Under tables 1 and estimates that establishments may notify respondent and 1 annual request to
2, the numbers of respondents are based an average of 20 selling agents and account for a possible submission to
on the estimated annual number of distributors of such suspension, and CBER or CDER of a request for an
manufacturers that submitted the provide FDA of such notification. The exception or alternative for constituent
required information to FDA or the number of respondents is based on the materials under § 610.15(d).
number of submissions FDA received in estimated annual number of There were a total of 2,777
fiscal year (FY) 2015. Based on suspensions of a biologic license. In amendments to an unapproved
information obtained from FDA’s table 1, FDA is estimating one in case application or supplement and
database systems, there are an estimated a suspension occurs. resubmissions submitted using Form
391 licensed biologics manufacturers. Under §§ 601.12(f)(4) and 601.45, FDA 356h.
The total annual responses are based on manufacturers of biological products FDA estimates the burden of this
the estimated number of submissions may use Form FDA 2253 to submit collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
21 CFR section Form FDA No. responses per burden per Total hours 10
respondents responses
respondent response

601.2(a) 2, 610.60 through 610.65 3 356h ................... 28 1.36 38 860 ..................... 32,680
601.5(a) ........................................... N/A ..................... 12 0.75 9 0.33 (20 minutes) 3
601.6(a) ........................................... N/A ..................... 1 1 1 1 ......................... 1
601.12(a)(5) ..................................... N/A ..................... 537 24.41 13,108 1 ......................... 13,108
601.12(b)(1)/(b)(3)/(e) ...................... 356h 2 ................. 164 3.66 600 80 ....................... 48,000
601.12(c)(1)/(c)(3) 5 ......................... 356h 2 ................. 120 4.78 574 50 ....................... 28,700
601.12(c)(5) ..................................... 356h 2 ................. 7 1.14 8 50 ....................... 400
601.12(d)(1)/(d)(3) 6/(f)(3) 8 .............. 356h 2 ................. 246 3.34 822 24 ....................... 19,728
601.12(f)(1) 7 .................................... 2253 ................... 72 1.93 139 40 ....................... 5,560
601.12(f)(2) 7 .................................... 2253 ................... 60 1.82 109 20 ....................... 2,180
601.12(f)(4)/601.45 9 ........................ 2253 ................... 114 102.42 11,676 10 ....................... 116,670
601.27(b) ......................................... N/A ..................... 20 16.50 330 24 ....................... 7,920
601.27(c) ......................................... N/A ..................... 12 1.08 13 8 ......................... 104
601.70(b) and (d)/601.28 ................ 2252 ................... 82 1.70 139 24 ....................... 3,336
610.15(d) ......................................... N/A ..................... 1 1 1 1 ......................... 1
680.1(c) ........................................... N/A ..................... 9 1 9 2 ......................... 18
680.1(b)(3)(iv) .................................. N/A ..................... 1 1 1 2 ......................... 2
sradovich on DSK3GDR082PROD with NOTICES

Amendments/Resubmissions .......... 356h ................... 125 22.22 2,777 20 ....................... 55,540

Total ......................................... ............................ ........................ ........................ ........................ ............................ 333,951
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 The reporting requirements under §§ 601.14, 601.27(a), 601.33, 601.34, 601.35, 610.9(a), 640.17, 640.25(c),
640.56(c), 640.74(b)(2), 660.51(a)(4), and 680.1(b)(2)(iii) are included in the estimate under § 601.2(a).
3 The reporting requirements under §§ 601.93(b)(3), 640.70(a), 640.74(b)(3) and (4), 640.84(a) and (c), 640.94(a), 660.2(c), 660.28(a), (b), and
(c), 660.35(a), (c through g), and (i through m), 660.45, and 660.55(a) and (b) are included under §§ 610.60 through 610.65.

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44872 Federal Register / Vol. 81, No. 132 / Monday, July 11, 2016 / Notices

4 The reporting requirements under §§ 601.12(a)(2) and (b)(4), 600.15(b), 610.9(a), 610.53(d), 606.110(b), 640.6, 640.17, 640.21(c), 640.22(c),
640.25(c), 640.56(c), 640.64(c), 640.74(a) and (b)(2), 640.120, and 680.1(d) are included in the estimate under § 601.12(b).
5 The reporting requirements under §§ 601.12(a)(2), 610.9(a), 640.17, 640.25(c), 640.56(c), and 640.74(b)(2) are included in the estimate under
§ 601.12(c).
6 The reporting requirement under § 601.12(a)(2) is included in the estimate under § 601.12(d).
7 The reporting requirement under § 601.14 is included in the estimate under § 601.12(f)(1) and (2).
8 The reporting requirement under §§ 601.12(a)(4) and 601.14 is included in the estimate under § 601.12(f)(3).
9 The reporting requirement under § 601.94 is included in the estimate under § 601.45.
10 The numbers in this column have been rounded to the nearest whole number.

Under table 2, the estimated recordkeeping requirements associated
recordkeeping burden of 1 hour is based with the AER system.
on previous estimates for the

TABLE 2—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Annual
Number of disclosures Total annual Average burden
21 CFR section Total hours 2
respondents per disclosures per disclosure
respondent

601.6(a) .................................................. 1 20 20 0.33 (20 minutes) ........................ 7
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Rounded to the nearest whole number.

Dated: July 5, 2016. to 6 p.m. Pickup of materials will begin starting interventions in childhood. The
Leslie Kux, at 7:30 a.m. literature suggests that myopia
Associate Commissioner for Policy. ADDRESSES: The public workshop will progression is most rapid between 6 and
[FR Doc. 2016–16352 Filed 7–8–16; 8:45 am] be held at the FDA White Oak Campus, 11 years of age and manipulating
BILLING CODE 4164–01–P 10903 New Hampshire Ave., Bldg. 31, peripheral retinal image quality may be
Conference Center, the Great Room, a treatment strategy to control axial
(Rm. 1503), Silver Spring, MD, 20993. length and therefore the progression of
DEPARTMENT OF HEALTH AND Entrance for the public workshop myopia. The results of studies
HUMAN SERVICES participants (non-FDA employees) is conducted with specialized contact
through Building 1 where routine lenses, both rigid and soft, have
Food and Drug Administration security check procedures will be indicated that this approach may reduce
performed. For parking and security the rate of myopic progression in
[Docket No. FDA–2016–N–0001] information, please refer to http:// children. As research into myopia
www.fda.gov/AboutFDA/ control is continuing at a rapid pace,
Controlling the Progression of Myopia: accompanying potential safety and
WorkingatFDA/BuildingsandFacilities/
Contact Lenses and Future Medical effectiveness questions also have
WhiteOakCampusInformation/
Devices; Public Workshop emerged. To ensure that the studies
ucm241740.htm.
AGENCY: Food and Drug Administration, FOR FURTHER INFORMATION CONTACT:
conducted provide information that can
HHS. Michelle Tarver, Office of Device adequately inform the regulatory
ACTION: Notice of public workshop. Evaluation, Center for Devices and review, we are conducting a workshop
Radiological Health, Food and Drug to answer questions about the
SUMMARY: The Food and Drug Administration, 10903 New Hampshire appropriate clinical trial design and
Administration (FDA), in cosponsorship Ave., Bldg. 66, Rm. 2504, Silver Spring, outcomes for these devices.
with the American Academy of MD 20993, 301–796–6884. II. Topics for Discussion at the Public
Ophthalmology (AAO), American SUPPLEMENTARY INFORMATION: Workshop
Academy of Optometry (AAOpt),
American Association for Pediatric I. Background Topics to be discussed at the public
Ophthalmology and Strabismus The prevalence of myopia in the workshop include, but are not limited to
(AAPOS), American Optometric United States has increased over the the following topics:
Association (AOA), American Society of past decade with approximately 24 • Myopia Demographics.
Cataract and Refractive Surgery percent (over 30 million) of adults over • Contact Lens Use and Safety in a
(ASCRS), and Contact Lens Association 40 years of age being affected. Recent Pediatric Population.
of Ophthalmologists, Inc. (CLAO) is studies have found the overall • Contact Lens Behaviors and
announcing a public workshop entitled prevalence of myopia to be 1.2 percent Hygiene.
‘‘Controlling the Progression of Myopia: among non-Hispanic White children, • Studies Conducted on Myopia
Contact Lenses and Future Medical 6.6 percent in African Americans, 3.7 Control Devices and Their Challenges.
Devices.’’ The purpose of this workshop percent in Hispanic, and 3.98 percent in • Regulation of Contact Lenses
sradovich on DSK3GDR082PROD with NOTICES

is to discuss the increasing prevalence Asian children. Pathologic myopia is (Ref. 1).
of myopia, as well as suggested clinical the third most frequent cause of • Patient/Caregiver Perspectives and
trial design attributes for studies using blindness due to retinal detachments or the Role in Trial Design and Conduct
contact lenses or other medical devices abnormal blood vessel growth. Given (Refs. 2 and 3).
to control the progression of myopia. these potentially poor outcomes with We will also have a panel discussion
DATES: The public workshop will be high myopia, researchers have sought to address questions related to the
held on September 30, 2016, from 8 a.m. ways to prevent its development by design of these clinical trials.

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Document Created: 2016-07-09 00:21:35
Document Modified: 2016-07-09 00:21:35
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.
Dates		Submit electronic or written comments on the collection of information by September 9, 2016.
Contact		FDA PRA Staff, Office of Operations, Food and Drug Administration, Three White Flint North 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, [email protected]
FR Citation		81 FR 44868
81 FR 44868 - Agency Information Collection Activities; Proposed Collection; Comment Request; General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Form FDA 356h

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 81, Issue 132 (July 11, 2016)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
