Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices 50885 

ADDRESSES: Written comments and 

recommendations for the proposed 

information collection should be sent 

within 30 days of publication of this 

notice to www.reginfo.gov/public/do/ 

PRAMain. Find this particular 

information collection by selecting 

‘‘Currently under 30-day Review—Open 

for Public Comments’’ or by using the 

search function. 

To obtain copies of a supporting 

statement and any related forms for the 

proposed collection(s) summarized in 

this notice, you may make your request 

using one of following: 

1. Access CMS’ website address at 

website address at: https://

www.cms.gov/Regulations-andGuidance/Legislation/Paperwork

ReductionActof1995/PRA-Listing.html. 

FOR FURTHER INFORMATION CONTACT: 

William Parham at (410) 786–4669. 

SUPPLEMENTARY INFORMATION: Under the 

Paperwork Reduction Act of 1995 (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. The term ‘‘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 publish a 30-day notice in the 

Federal Register concerning each 

proposed collection of information, 

including each proposed extension or 

reinstatement of an existing collection 

of information, before submitting the 

collection to OMB for approval. To 

comply with this requirement, CMS is 

publishing this notice that summarizes 

the following proposed collection(s) of 

information for public comment: 

1. Type of Information Collection 

Request: Revision of a currently 

approved collection; Title of 

Information Collection: State Children’s 

Health Insurance Program and 

Supporting Regulations; Use: States 

must submit title XXI plans and 

amendments for approval by the 

Secretary. We use the plan and its 

subsequent amendments to determine if 

the state has met the requirements of 

title XXI. Information provided in the 

state plan, state plan amendments, and 

from the other information we are 

collecting will be used by advocacy 

groups, beneficiaries, applicants, other 

governmental agencies, providers 

groups, research organizations, health 

care corporations, health care 

consultants. States will use the 

information collected to assess state 

plan performance, health outcomes and 

an evaluation of the amount of 

substitution of private coverage that 

occurs as a result of the subsidies and 

the effect of the subsidies on access to 

coverage. 

This iteration proposes to: Remove 

certain reporting requirements, revise 

the information collection instrument, 

and revise reporting instructions. We 

are also proposing to change the 

respondent’s occupation and hourly 

wage, adjust the number of respondents, 

and adjust the number of enrollees by 

using more recent data. Form Number: 

CMS–R–308 (OMB control number: 

0938–0841); Frequency: Yearly, Once, 

and Occasionally; Affected Public: State, 

Local, or Tribal Governments; Number 

of Respondents: 51; Total Annual 

Responses: 9,677,272; Total Annual 

Hours: 485,940. (For policy questions 

regarding this collection contact Cassie 

Lagorio at 410–786–4554.) 

Dated: September 7, 2021. 

William N. Parham, III, 

Director, Paperwork Reduction Staff, Office 

of Strategic Operations and Regulatory 

Affairs. 

[FR Doc. 2021–19599 Filed 9–10–21; 8:45 am] 

BILLING CODE 4120–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0008] 

Blood Products Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) 

announces a forthcoming public 

advisory committee meeting of the 

Blood Products Advisory Committee. 

The general function of the committee is 

to provide advice and recommendations 

to the Agency on FDA’s regulatory 

issues. Members will participate via 

teleconference. At least one portion of 

the meeting will be closed to the public. 

DATES: The meeting will be held on 

November 4, 2021, from 9:30 a.m. to 

5:20 p.m. Eastern Time. 

ADDRESSES: Please note that due to the 

impact of the COVID–19 pandemic, all 

meeting participants will be joining this 

advisory committee meeting via an 

online teleconferencing platform. The 

online web conference meeting will be 

available at the following link on the 

day of the meeting: https://youtu.be/ 

2Xz4YzkwNDs. 

FOR FURTHER INFORMATION CONTACT: 

Christina Vert or Joanne Lipkind, Center 

for Biologics Evaluation and Research, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

6268, Silver Spring, MD 20993–0002, 

240–402–8054, Christina.Vert@

fda.hhs.gov, or 240–402–8106, 

Joanne.Lipkind@fda.hhs.gov, 

respectively, or FDA Advisory 

Committee Information Line, 1–800– 

741–8138 (301–443–0572 in the 

Washington, DC area). A notice in the 

Federal Register about last minute 

modifications that impact a previously 

announced advisory committee meeting 

cannot always be published quickly 

enough to provide timely notice. 

Therefore, you should always check the 

Agency’s website at https://

www.fda.gov/AdvisoryCommittees/ 

default.htm and scroll down to the 

appropriate advisory committee meeting 

link, or call the advisory committee 

information line to learn about possible 

modifications before coming to the 

meeting. 

SUPPLEMENTARY INFORMATION: 

Agenda: The meeting presentations 

will be heard, viewed, captioned, and 

recorded through an online 

teleconferencing platform. On 

November 4, 2021, for Topic I, the 

committee will meet in open session to 

hear an overview of the research 

programs of the Plasma Derivatives 

Branch, Division of Plasma Protein 

Therapeutics, Office of Tissues and 

Advanced Therapies, Center for 

Biologics Evaluation and Research 

(CBER). For Topic II, the committee will 

meet in open session to hear an 

overview of the research programs of the 

Laboratory of Cellular Hematology, 

Division of Blood Components and 

Devices, Office of Blood Research and 

Review (OBRR), CBER. For Topic III, the 

committee will meet in open session to 

hear an overview of the research 

programs of the Laboratory of Emerging 

Pathogens, Division of Emerging & 

Transfusion Transmitted Diseases, 

OBRR, CBER. After the open sessions, 

the meeting will be closed to the public 

for committee deliberations. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its website prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s website after 

the meeting. Background material is 


lotter on DSK11XQN23PROD with NOTICES1
50886 Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices 

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

AdvisoryCommittees/Calendar/ 

default.htm. Scroll down to the 

appropriate advisory committee meeting 

link. 

Procedure: On November 4, 2021, the 

meeting is open to the public, from 9:30 

a.m. to 11:30 a.m. for Topic I; 12:50 p.m. 

to 2:10 p.m. for Topic II; and 3:10 p.m. 

to 4:30 p.m. for Topic III. Interested 

persons may present data, information, 

or views, orally or in writing, on issues 

pending before the committee. Written 

submissions may be submitted to the 

contact person on or before October 28, 

2021. Oral presentations from the public 

will be scheduled between 

approximately 11:10 a.m. and 11:30 a.m. 

for Topic I; 1:50 p.m. and 2:10 p.m. for 

Topic II; and 4:10 p.m. and 4:30 p.m. for 

Topic III. Those individuals interested 

in making formal oral presentations 

should notify the contact person and 

submit a brief statement of the general 

nature of the evidence or arguments 

they wish to present, the names and 

addresses of proposed participants, and 

an indication of the approximate time 

requested to make their presentation on 

or before October 20, 2021. Time 

allotted for each presentation may be 

limited. If the number of registrants 

requesting to speak is greater than can 

be reasonably accommodated during the 

scheduled open public hearing session, 

FDA may conduct a lottery to determine 

the speakers for the scheduled open 

public hearing session. The contact 

person will notify interested persons 

regarding their request to speak by 

October 21, 2021. 

Closed Committee Deliberations: On 

November 4, 2021, from 11:30 a.m. to 

12:20 p.m. for Topic I; 2:10 p.m. to 3 

p.m. for Topic II; and 4:30 p.m. to 5:20 

p.m. for Topic III, the meeting will be 

closed to permit discussion where 

disclosure would constitute a clearly 

unwarranted invasion of personal 

privacy (5 U.S.C. 552b(c)(6)). The 

recommendations of the advisory 

committee regarding the progress of the 

individual investigator’s research 

programs along with other information, 

will be discussed during this session. 

We believe that public discussion of 

these recommendations on individual 

scientists would constitute an 

unwarranted invasion of personal 

privacy. 

For press inquiries, please contact the 

Office of Media Affairs at fdaoma@

fda.hhs.gov or 301–796–4540. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with disabilities. 

If you require accommodations due to a 

disability, please contact Christina Vert 

(BPAC@fda.hhs.gov) at least 7 days in 

advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our website at 

https://www.fda.gov/advisorycommittees/about-advisory-committees/ 

public-conduct-during-fda-advisorycommittee-meetings for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: September 3, 2021. 

Lauren K. Roth, 

Acting Principal Associate Commissioner for 

Policy. 

[FR Doc. 2021–19686 Filed 9–10–21; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2021–N–0104] 

PolyMedica Industries Inc., et al.; 

Withdrawal of Approval of Three New 

Drug Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is withdrawing 

approval of three new drug applications 

(NDAs) from multiple holders of those 

NDAs. The basis for the withdrawal is 

that these NDA holders have repeatedly 

failed to file required annual reports for 

those NDAs. 

DATES: Approval is withdrawn as of 

September 13, 2021. 

FOR FURTHER INFORMATION CONTACT: 

Kimberly S. Lehrfeld, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 51, Rm. 6226, 

Silver Spring, MD 20993–0002, 301– 

796–3137, Kimberly.Lehrfeld@

fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: The 

holder of an approved application to 

market a new drug for human use is 

required to submit annual reports to 

FDA concerning its approved 

application in accordance with § 314.81 

(21 CFR 314.81). 

In the Federal Register of March 3, 

2021 (86 FR 12474), FDA published a 

notice offering an opportunity for a 

hearing (NOOH) on a proposal to 

withdraw approval of those NDAs 

because the holders of those NDAs had 

repeatedly failed to submit the required 

annual reports for those NDAs. The 

holders of the NDAs identified in table 

1 did not respond to the NOOH. Failure 

to file a written notice of participation 

and request for hearing as required by 

§ 314.200 (21 CFR 314.200) constitutes 

an election by those holders of the 

NDAs not to make use of the 

opportunity for a hearing concerning the 

proposal to withdraw approval of their 

NDAs and a waiver of any contentions 

concerning the legal status of the drug 

products. Therefore, FDA is 

withdrawing approval of the three 

applications listed in table 1. 

TABLE 1—APPROVED NDAS FOR WHICH REQUIRED REPORTS HAVE NOT BEEN SUBMITTED

Application No. Drug NDA Holder 

NDA 016401 ............ Neopap (acetaminophen) Suppositories, 120 milligrams 

(mg).

PolyMedica Industries Inc., 2 Constitution Way, Woburn, 

MA 01801. 

NDA 050266 ............ Achromycin (tetracycline hydrochloride (HCl)) Ophthalmic 

Ointment, 10 mg/gram.

Storz Ophthalmics Inc. (subsidiary of American Cyanamid 

Co.), 401 North Middletown Rd., Pearl River, NY 10965. 

NDA 050268 ............ Achromycin (tetracycline HCl) Ophthalmic Suspension, 1% Do. 

FDA finds that the holders of the 

NDAs listed in table 1 have repeatedly 

failed to submit reports required by 

§ 314.81. In addition, under § 314.200, 

FDA finds that the holders of the NDAs 

have waived any contentions 

concerning the legal status of the drug 

products. Therefore, under these 

findings, approval of the NDAs listed in 

table 1 and all amendments and 

supplements thereto is hereby 

withdrawn as of September 13, 2021. 


lotter on DSK11XQN23PROD with NOTICES1